Third Party Pharma Manufacturing in India: A Complete Guide for 2027

27 October 2026 | By Admin

Third party pharma manufacturing in India allows pharmaceutical businesses to outsource drug production to licensed manufacturers. This guide for 2027 covers the manufacturing process, investment requirements, product selection, quality standards, regulatory compliance and key factors for choosing a reliable manufacturing partner.

Third party pharma manufacturing in India means that an established pharmaceutical brand, PCD franchise company, or startup will have its products manufactured for it by an authorised manufacturer without setting up its own factory. The pharma marketing company would be responsible for managing the product range, branding, marketing and distribution, while the manufacturer would be responsible for making the formulations, manufacturing, controlling quality and packaging. This document provides insight into how the process works, how much it will cost, what documentation would be required, how to select the partner and what to avoid.

 

According to press reports quoting government officials, there are more than 10,500 pharma product manufacturing plants in India, out of which 8,500 are from the MSME sector. There is certainly a lot of choice available, but this is also exactly why choosing the right partner becomes crucial. A poorly chosen one can damage all these.

 

Key Takeaways

 

• Third Party Pharma Manufacturing allows brand ownership to be distinct from manufacturing; hence, you can market products without owning a plant.
• Your manufacturer must have a license for products manufacturing and your products must match the dosage forms and categories mentioned in the license.
• All documentation, licenses and labelling issues need to be addressed prior to the manufacturing of the first batch.
• The MOQ and price will depend largely on dosage form, formulation, packaging and the batch size.
• There have been updates in the Schedule M (GMP) which apply to all manufacturers in India; hence, always ask for compliance.

 

What is Third Party Pharma Manufacturing?

 

Third Party Pharma Manufacturing, also known as contract manufacturing, refers to an agreement between two companies whereby one firm contracts out the manufacture of products to another company. This is because the brand owner markets the product under its own brand name and trademark. The manufacturer produces them at its own licensed facility, following the marketer's specifications and agreed quality standards.

 

How this Business Model Works?

 

The concept is built around a very basic allocation of tasks. The marketer selects the products to produce, designs the packaging for the products and markets the brand to the doctors, chemists, distributors and institutions, while the manufacturer acquires the raw materials and packaging materials, manufactures the products and delivers them. An agreement is entered into between the two parties on the list of the goods, the cost, quality and delivery deadline.

 

As the marketer does not have to have land, plant, machinery and a large technical workforce, the barriers to entry are much reduced compared to own-plant manufacturing. That is why startups, PCD pharma franchise companies, export companies and even established brands opt for Third Party Pharma Manufacturing.

 

Third Party Manufacturing and the Law

 

Indian drug law is worth understanding before you sign any agreement. Neither the Drugs and Cosmetics Act, 1940 nor the Drugs and Cosmetics Rules, 1945 make any provision for "Third Party Manufacturing" as a separate licensing category. There are, in fact, two ways in which it can be done legally.

 

In the first structure, the third party manufacturer holds the manufacturing licence and the marketer sells the product under its own brand, with both names shown on the label. In the second structure, the marketer obtains a loan licence (Form 25A or Form 28A, depending on the product category) to manufacture at another licensee's premises. Legal scholars point out that the Rules permit manufacture in a factory belonging to some other licensee via the loan licence procedure, while the Drugs Rules also explain what the term "marketer" means. Since different conditions apply to different products in different states, it is recommended that you seek professional guidance first.

 

Who Uses This Model?

 

• Start-up pharma and nutraceutical brands with limited capital
• PCD pharma franchise companies that need a steady supply of branded generics
• Established companies adding new dosage forms or therapy segments
• Export-oriented companies that need WHO-GMP certified production
• Hospital supply, institutional and government tender suppliers

 

What are the Benefits of Third Party Manufacturing?

The process is favoured because it changes a high fixed-cost business model to a low cost and dynamic business model. There are many benefits which are grouped into three categories: Investments, Production capabilities and Operations.

 

Lower Investments and Rapid Launch

 

Developing an FDA-compliant plant requires land, clean rooms, utilities, water supply system, manufacturing equipment, QC laboratory facilities and labour. This service reduces the need for all these investments. Your money is invested in developing the product, branding and marketing it. The other benefit is that you will not need to wait for several years to set up the manufacturing facility.

 

Access to Production Capacity

 

An ideal contract manufacturer operates more than one dosage-form line with pre-existing batch sizes. This helps you to increase or reduce the production size depending on the needs of the market. For instance, Systole Remedies, a third party manufacturing company, indicates that its production facility is capable of handling both large and small-scale production processes, something that will work well for both a new brand trying out the market and an old brand with high demands.

 

Advantages of Operation

 

• Regulatory compliance: all about licensing, labelling and inspection is known to a contract manufacturer.
• Technical expertise: formulation, stability and analysis experts are available without hiring them.
• Broad range of products: a single manufacturer can manufacture tablets, capsules, syrups, injections, etc., and thus deal with only one supplier but not several.
• More time for sales: focus on marketing to doctors, distributors and expanding the market and not the manufacturing plant.
• Less risky: no investment in machinery that can become obsolete.

 

Where Third Party Manufacturing May Not Suit You?

 

The model is not perfect. You depend on another company's quality discipline, so a supplier failure becomes your failure in the market. You also have less direct control over scheduling. These risks are manageable through careful selection, a clear quality agreement and regular audits, which this guide covers in later sections.

 

Third Party Manufacturing Process

 

The following process illustrates how a standard Third Party Pharma Manufacturing project would progress from the initial inquiry up to delivery. Timeframes depend upon the type of product as well as the readiness of the documentation.

 

Step 1: Inquiry and Requirements Discussion

 

Mention the requirements you have regarding the product name, product formula, dose strength, quantity, packing and market destination. The manufacturer verifies the feasibility of the same, confirms the products fall under the licensed categories and discusses its manufacturing capability.

 

Step 2: Product Selection and Formulation Discussion

 

The next step involves selecting the products. For already developed generics, the manufacturer uses its own formulations. For custom products, the technical team discusses the formulation, including composition, strength, excipients and stability. In case of any novel drug or fixed-dose combinations that require regulatory clearance, this is the stage where you need to ensure its approval status.

 

Step 3: Quotation and Agreement

 

The supplier quotes prices for each product, minimum order quantity, packaging and payment terms. On accepting the same, both parties enter into a manufacturing agreement. A good agreement involves confidentiality, quality responsibility, batch release procedure, complaints and handling, recall procedure, labelling responsibility, and termination clauses.

 

Step 4: Submission of Documents & Label Artwork Validation

 

Submission of documents on business, trademarks and licenses for your structure as well as label artwork, is made. The regulatory team at the manufacturer ensures that the artwork is validated according to the labelling laws like manufacturer’s name and address, license number, batch number, manufacture and expiry dates and marketer.

 

Step 5: Procurement of Raw Materials & Packaging Materials

 

Upon validation of artwork and placing of order, procurement of active pharmaceutical ingredients, excipients and packaging material from approved suppliers is made.

 

Step 6: Manufacture and In-Process QC

 

The batch is manufactured according to good manufacturing practices. In-process inspection of quality parameters is done through blending, tablet weight and hardness, fill volumes and sterility of the injectable preparations.

 

Step 7: Release of the Product

 

The QC laboratory performs tests on the finished product to meet the specifications of identification, assay, disintegration/dissolution, if any and microbial limits. Batches that pass the tests only are released and there is usually an accompanying certificate of analysis upon release.

 

Step 8: Packaging, Shipping and Delivery

 

Released batches are packed in your own brand packs and shippers and shipped out to your own warehouse or distributors. Good 3rd Party Manufacturer always provide batch information, test report and invoice with each shipment. Retained samples are kept at the manufacturer's premises for the lifetime of the product as per the quality system requirements.

 

Typical Timeline

 

There are various factors affecting the timeline such as dosage form, availability of raw materials and the completeness of documentation provided. Generally, simpler oral solid dosage forms take less time than injectable dosage forms due to sterility testing and validation. You should request a written timeline at the quotation stage.

Documents Required for Third Party Pharma Manufacturing

 

The document requirements will be based on your form of business, product types, and the state where you are operating. The following is a list of documents that most customers should have ready.

 

Business Documents

 

Evidence of the organization’s constitution: partnership deed, LLP agreement, or Certificate of Incorporation along with Memorandum and Articles of Association
 

• PAN of the firm or company
• GST registration certificate
• Proof of business premises, such as a rent agreement or ownership document
• Identity and address proof of proprietor, partners or directors
• Bank account details and cancelled cheque for payments

 

Licences

 

According to the Drugs & Cosmetics Rules, 1945, a company intending to market its own brand has to take a legal route. The most common routes taken are:

 

• License with the manufacturer: the manufacturing unit possesses a license under form 25 (in case of drugs other than Schedule C & C (1)) and form 28 (for schedule C & C (1) drugs), while you are acting as a marketer.
• License on loan: you have a license under form 25A and form 28A to manufacture at another licensee’s premises. Application forms are Form 24A for non-Schedule C/C(1) products and Form 27A for Schedule C/C(1) products. A wholesale drug licence is generally required, and the loan licence route does not cover Schedule X drugs.
• Wholesale or distribution licence: if you sell to chemists and distributors, a valid wholesale drug licence is required in your state.

 

Product Permissions

 

The majority of generic preparations can be produced under the manufacturing company's license that shows the list of authorized products. At the same time, in order to manufacture and sell a new product or fixed-dose combination, approval according to New Drugs and Clinical Trials Rules, 2019 should be obtained. Inquire about your manufacturing company's list of product approvals and make sure all items intended for marketing are included in the list. A product approval list can be found on Systole Remedies website.

 

Brand and Packaging Documents

 

• Trademark registration certificate or application acknowledgement for your brand name
• Final label, carton and package insert artwork
• Product composition and specification sheets for custom formulations

 

Compliance Documents to Request from the Manufacturer

 

• Copy of valid manufacturing licence and product approval list
• GMP certification, such as WHO-GMP, along with evidence of compliance with the revised Schedule M
• ISO certification, where claimed
• Sample certificates of analysis and batch manufacturing records
• Quality agreement template

 

Price Control and Other Rules

 

Some products have their ceiling prices fixed by the Drugs (Price Control) Order, 2013 for the schedule medicines. According to legal commentaries, marketers are considered a part of the "manufacturer" in the context of price control, thus you are jointly responsible for complying with the pricing. Nutraceuticals and food supplements might be regulated according to FSSAI guidelines rather than the drug guidelines depending upon the nature of the product.

 

Important: This section contains general information only. Procedures related to License, fees, etc. vary and there is a different procedure for every state licensing authority. Verify the present procedure at CDSCO website or State Drugs Control Department before the application.

 

Minimum Order Quantity (MOQ) in Third Party Manufacturing

 

Minimum Order Quantity is the minimum quantity of a product a manufacturer will accept. There is Minimum Order Quantity because every batch has a fixed cost of setting up. Some of the costs associated with every batch of production are machine cleaning, set-up cost, quality assurance, documentation, etc.

 

Factors That Affect MOQ

 

• Formulation: The formulations of tablets and capsules will be made in larger batches; injectables, ointment and eye drop formulations may require different batch sizes owing to machine and sterility requirements.
• Machine and batch size: each machine has an optimum batch size. Operating far below this is a waste of machine capacity.
• Raw material purchase: certain APIs and excipients will be available only in set pack sizes, thereby dictating a practical minimum.
• Products Packaging: blisters, strips, bottles, ampoules and vials all require minimum print orders and material orders, and customized printed cartons also have their minimum print run.
• Formulation complexity: some formulations that have some processing requirements such as coating, special release or sterile fill might need large quantities to make it economical.
• Batch testing and validation: every batch needs to be tested, and the first batches might also need more validation tests; thus the minimum quantity required.

 

Approach to MOQ

 

MOQ can be stated as per product, per batch or per order, but varies from manufacturer to manufacturer. As there is no universal number, be careful about any claims made on standard MOQ. Instead, ask for a list of MOQ for all of the items from the selected Third Party Pharma Manufacturers , along with the low MOQ for trial orders.

 

MOQ Management – The Right Way?

 

• Create a selective product list in order to achieve MOQ without overstocking.
• Select products that are in steady demand in the distribution chain.
• Blend products according to the manufacturer’s policy.
• Take shelf life into consideration as dead stock leads to wastage of working capital.
• Consider staged deliveries against one large production lot whenever possible.

 

Third Party Manufacturing Cost

 

The cost for Third Party Manufacturing is different for each product type. Since one unit cost does not apply to all tablets, syrups, and injections, smart consumers compare quotations based on the same specification and not the lower number. Here are the primary cost factors:

 

Pricing Factors

 

• Formulation and raw materials: the API, its grade and its market price are often the biggest part of the cost. Complex or branded formulations are costlier than generic formulations.
• Formulation: Injectable or sterile dosage forms have higher equipment and testing costs than regular tablet or syrup formulations.
• Batches: Larger batch sizes lower the unit cost because the setup and testing costs will be shared among more units.
• Packaging: The cost is increased by blister packaging, alu-alu packing, amber bottles, printed boxes, leaflets, and shippers. Quality packaging makes the product more appealing and stable, but it also increases the cost.
• Quality testing: Quality testing, stability testing, or analytical testing increases the cost.
• Design: Changes in artwork or printing, such as new cartons or minimum print runs, incur one-time costs.
• Logistics: Freight charges, insurance, cold chain logistics for temperature-sensitive products, and proximity of your warehouse all matter.
• GST: The supply of pharmaceutical products attracts GST and the GST varies by product category. Consult your tax adviser about the GST applicable on the product.

 

Read the Quotation Carefully

 

A good quotation contains information on product, strength, packaging quantity, rate, minimum order quantity, validity period and payment terms. Confirm if packaging costs, artwork fees, testing fees, and GST have been included in the cost per unit. In addition, too low prices might conceal the lack of inclusion of the aforementioned fees and poor quality of raw materials used as well as the quality assurance process.

 

Cost vs. Value

 

Manufacturing your goods at a cheap cost, which results in a failed production lot, complaints from consumers in the market or even a recall, is a lot more expensive than paying reasonable prices for good quality. Treat your manufacturer as a partner and compare other factors along with the cost.

 

Pharmaceutical Product Categories Available for Third Party Manufacturing

 

A good manufacturer will provide various forms of products across different therapy segments. The following table shows some of these product categories.

 

Dosage Form	Common Examples	What to Check
Tablets	Antibiotics, analgesics, antacids, antidiabetics, cardiac medicines	Beta-lactam and non-beta-lactam segregation, coating and blister options
Capsules	Antibiotics, multivitamins, digestive enzymes, probiotics	Hard gelatin versus softgel capability, cross-contamination controls
Syrups and Suspensions	Cough syrups, tonics, paediatric suspensions, antacid liquids	Liquid section capacity, bottle types, preservative systems
Dry Syrups	Paediatric antibiotics and other reconstitution powders	Separate beta-lactam and non-beta-lactam facilities, reconstitution stability
Injections	Liquid and dry injectables, antibiotics, analgesics	Sterile area standards, sterility testing, ampoule and vial lines
Ointments and Creams	Antifungals, antibacterials, anti-inflammatory topicals	Tube filling, homogeniser capability, content uniformity
Eye and Ear Drops	Antibiotic, lubricant and anti-allergy drops	Ophthalmic-grade controls, sterility and particulate limits

 

Tablets and Capsules

 

Oral solids form the core of most portfolios. There are tablets that include plain, film-coated, and sugar-coated forms. There are also capsules such as hard gelatin capsules containing powders and pellets. You need to determine whether there are dedicated facilities by the Third Party Pharma Company for the production of beta-lactams like penicillin and cephalosporins.

 

Syrups, Suspensions and Dry Syrups

 

Liquids can be used for children and older patients. Dry syrups are powder formulations reconstituted with water upon use. The dry form is preferred in the case of antibiotics due to stability reasons. You should inquire about the type of packaging bottles used, closure system, and the stability of the reconstituted dry syrup formulation.

 

Injections

 

Liquid and dry powder injections fall under the category of injectables. They require clean rooms, sterility assurance systems and extensive testing. As failure to adhere to this process results in risks to patient safety, special attention should be paid to the sterilization facility's compliance and inspection records.

 

Ointments, Eye Drops and Ear Drops

 

These products have their requirements for filling lines and, for eye and ear drops, sterile/low bioburden control. The mentioned segments may typically belong to dermatology, ENT and ophthalmology franchises.

 

Therapeutic Areas

 

Quite a lot of companies categorize their products according to therapy areas, not forms. Typical therapeutic ranges include cardiac, diabetic, hormones, gynaecology, paediatrics, orthopaedics, dermatology, ophthalmology, critical care, neurology, nephrology and urology. Systole Remedies offers contract manufacturing of tablets, capsules, syrups, dry syrups, injections, ointments, ear drops, eye drops and cardiac, hormones and diabetic ranges; and their website features a range of PCD segments including gynae, pediatric, oncology, ortho, derma, critical care, neurology, nephrology and urology.

 

Quality Standards and Regulatory Framework in Pharma Manufacturing

 

It is always better to be aware of some of the standards that you are likely to encounter during your conversations with manufacturers since quality is the basic requirement of all good manufacturing relationships.

 

GMP and Revised Schedule M

 

GMPs pertain to the guidelines that ensure the production of medicines according to the necessary consistency and requirements. In India, GMPs are prescribed under schedule M of the Drugs and Cosmetics Rules. It has been notified by the Ministry of Health and Family Welfare on the revision of Schedule M in December 2023, which ensures that Indian practices are aligned with the standards of WHO. Larger manufacturing firms have been granted a short transition period, while smaller or medium manufacturing firms having turnover below Rs 250 crore have been granted an extension up to 31 December 2025. As of 1 January 2026, the new rules will apply to manufacturing firms in India.

 

WHO-GMP Certification

 

The WHO-GMP Certification means that the facility complies with GMP standards consistent with the World Health Organization. It is the preferred or required certification for many export markets and institutional customers. According to various press reports, only a small percentage of Indian MSME facilities are WHO-GMP certified; therefore, the WHO-GMP certification is an important differentiator. One should always ensure to view the certification, its expiration date and its scope, which may be only for some products or dosage forms.

 

ISO and GLP

 

The ISO certifications include ISO 9001. Good Laboratory Practice (GLP) is a set of procedures for conducting, documenting, and planning laboratory research and testing. This practice is not intended as an alternative to a valid manufacturing license or GMP, but may be considered an additional safety measure. The certification year and the version of the standards must be up-to-date.
 

Third Party Manufacturing vs. Own Manufacturing vs. PCD Franchise

Brand owners often confuse these three models, so it helps to compare them side by side.

 

Factor	Third Party Manufacturing	Own Manufacturing	PCD Pharma Franchise
Investment	Low to moderate	High (land, plant, machinery)	Low
Brand ownership	Your own brand	Your own brand	Usually, the parent company's brand
Control over production	Shared, through agreements	Full	Limited
Time to launch	Months	Often years	Fast
Best suited for	Brand builders and growing companies	Large, established companies	Distributors and entrepreneurs entering pharma sales

 

In a PCD franchise, you market the parent company's products in an assigned territory. In Third Party Pharma Manufacturing, you build and own the brand while the manufacturer makes the product. Some businesses start with a PCD franchise to learn the market and then move to their own brands through contract manufacturing.

 

How to Choose a Third Party Pharma Manufacturer in India?

 

Manufacturer selection is the most crucial step in this business. Follow the checklist given below for evaluating potential manufacturers based on facts and not claims.

 

1. Licenses and Certifications

 

Request the manufacturing license and the product approval list. See whether the license is valid for you and your products. A buyer would prefer WHO-GMP certification, ISO certification and, even better, compliance with the Revised Schedule M. According to Systole Remedies, they are ISO- and WHO-GMP-certified.

 

2. Quality Systems

 

A reliable manufacturer has a documented quality management system. It should include a quality assurance team that is independent of production, standard operating procedures, change control, deviation and complaint handling, batch release procedures and recall procedures. Ask who releases batches and how out-of-specification results are investigated.

 

3. Manufacturing Capabilities

 

Make sure that the producer can manufacture the dosage forms that you want. It is also important to ensure that the manufacturer has enough manufacturing capacity, batch size, beta-lactam and sterile areas, and test laboratories. The producer with production facilities and test laboratories under its control can control quality better than the other producer.

 

4. Documentation and Transparency

 

Request sample batch records, certificates of analysis and artwork approval procedures. A transparent partner shares these readily and explains its documentation system. Hesitation here is a warning sign.

 

5. Facilities Audit

 

If possible, inspect the manufacturing plant. Look at its cleanliness, material handling, storage areas, laboratories, and staff training. If not, request an inspection report or arrange an independent audit.

 

6. Sourcing of Raw Materials

 

Inquire into the sources of APIs and other raw materials, vendor qualification process, and testing of the incoming materials. A sound source is critical to assure quality and availability.

 

7. Delivery Performance and Communications

 

Ask for lead times and means of communicating any delays and who to contact at the manufacturing company. Try to contact the existing clients wherever possible.

 

8. Price and Terms

 

Comparison of quotations must be done by keeping the specifications the same. Pricing terms, MOQ, pricing changes, confidentiality, and termination clauses must be considered.

 

9. Location and Logistics

 

Manufacturing in a cluster with good road and rail connectivity reduces logistics time. Systole Remedies is located in Village Ogli, Kala Amb, District Sirmaur, Himachal Pradesh, which is an established manufacturing area in India, and claims to provide its services to clients all over India.

 

Common Errors to Avoid

 

Most errors made in contract manufacturing are predictable and avoidable. They are the errors that buyers generally make along with the questions needed to prevent them.

 

Mistake 1: Making a Decision Solely Based on Quotation

 

Sometimes the most economical quotation may be an indication of low-quality ingredients, reduced quality tests or other costs that have been hidden. Think about this: what do you really get for your money?

 

Mistake 2: Neglecting the Licence and Approval Status

 

It's assumed that any manufacturer can manufacture any item. Consider: Are all products I need manufactured and approved in accordance with your licence?

 

Mistake 3: Not Considering the Legal Structure

 

Using a different company’s licence to promote the products and lacking a label or a separate licence can lead to you being held liable under drug regulations. Consider: Which legal structure do I need for my brand? How should it be marked?

 

Mistake 4: No Certificate of Compliance

 

A certificate of compliance is not about how compliant your company is with the existing requirements. For example, is your production facility compliant with the revised Schedule M? When did you have the last regulatory audit?

 

Mistake 5: No Terms of Cooperation

 

All is well until something goes wrong, but there are no terms of cooperation. Would you cooperate on issues such as Responsibility, Batch Rejection, Recall Costs, Confidentiality, and Termination of Cooperation?

 

Mistake 6: Unclear MOQ and Delivery Timeline

 

An ambiguous MOQ will bring overstocking and an ambiguous delivery timeline will result in understocking. For instance, what MOQ does a specific product have and what is the guarantee of the delivery timeline?

 

Mistake 7: Bad Artwork & Labelling

 

Labelling mistakes lead to delays, the need for redo and non-compliance. Who would check my artwork based on your labelling requirements?

 

Mistake 8: No Visit / Audit

 

It is impossible for me to understand the manufacturing capacity by means of only reading a brochure. Will I have the possibility of seeing your manufacturing plant, examining your paperwork, and speaking with your quality control staff?

 

Mistake 9: Ordering too much initially

 

Over-ordering will be hard to handle and might expire eventually. Question to ask: Is it possible to place smaller quantities initially?

 

Mistake 10: Not Taking Your Needs into Account After Purchase

 

Questions of effectiveness in the market and stability of the product will become apparent. Question to ask: What about complaint handling and how long would I have to wait for help?

 

Pre-Signing Checklist for Third Party Pharma Manufacturing

 

• Use this short checklist before you sign any manufacturing agreement. Each item should be confirmed in writing.
• The manufacturing license is valid and encompasses all the products and forms mentioned in your list.
• There are product authorizations for new drugs and for fixed-dose combinations.
• The GMP, WHO-GMP, and ISO certifications are valid, and you have reviewed the scope.
• The legal arrangement (manufacturer’s license or loan license) has been decided and is in writing.
• Product-wise MOQ, rates, packaging specifications and GST treatment are stated in the quotation.
• Artwork has been approved against labelling requirements before printing.
• The agreement covers quality responsibilities, batch rejection, recall, confidentiality and exit terms.
• Lead times and dispatch commitments are written down.
• You have audited the facility or received an independent audit report.

 

Why Choose Systole Remedies for Third Party Pharma Manufacturing?

 

Systole Remedies Pvt. Ltd. is a pharmaceutical manufacturer based in Kala Amb, Himachal Pradesh. Based on information published on its website, the company offers the following to marketers and brand owners.

 

• Certifications: The company claims to be ISO and WHO-GMP certified. GLP is also amongst the certifications.
• Product Range: tablets, capsules, syrups, dry syrups, injectables, ointments, eye drops, ear drops, cardiac range, hormonal range, diabetic range, and beta-lactam along with non-beta-lactam range of medicines.
• Manufacturing unit: Manufacturing unit that can handle big as well as small orders.
• Technical Team and Equipment: a technically skilled team and modern equipment, as provided by the company.
• Packaging Assistance: assistance in providing quality packaging material and packaging design.
• Pan-India Service: third party manufacturing assistance throughout India.

 

Read more about the company’s capacities on their special web page: Third Party Pharma Manufacturing Company in India. As is the case with any supplier, it is important that one confirms the credentials, licensing and product approval with the supplier prior to conducting the transaction.

 

Frequently Asked Questions

 

Q1. What is Third Party Pharma Manufacturing?

 

Third Party Pharma Manufacturing is the process through which a licensed manufacturer produces the drugs for another company that will sell them under its own name.

 

Is it necessary for me to have a manufacturing facility for setting up a pharma business with the help of third party manufacturing?

 

Not necessarily. It's not required to have your own facility because the manufacturer will provide all such facilities, machinery and skilled personnel. You will require only the business registration, legal licensing structure, product permits and wholesaler's license.

 

Q2. What licenses are necessary for Third Party Pharma Manufacturing in India?

 

The manufacturing company should possess a valid manufacturing license in Form 25 or Form 28. In case you manufacture using loan license, then Form 25A or Form 28A will be required. You will also require the wholesale drug license and GST registration.

 

Q3. What is MOQ in third party pharma manufacturing?

 

MOQ is an acronym for Minimum Order Quantity, which indicates the smallest order quantity of orders taken by the manufacturer for the concerned product. MOQ is dependent on the dosage form, machinery, number of raw materials in the packing, packaging, and the formulation itself. It is always advisable to request a written quotation for the MOQ of each product.

 

Q4. What is the cost involved in third party pharma manufacturing?

 

This will depend upon the type of formulation, the API cost, dosage form, batch size, packaging, testing and logistics. Injectable products will have a higher cost compared to basic tablets. Always compare written quotations for the same specifications and see what all is covered like artwork and GST.

 

Q5. What dosage forms can be manufactured under third party pharma manufacturing agreements?

 

Some common dosage forms include tablets, capsules, syrups, dry syrups, injections, ointments, and eye and ear drops. This will depend on the type of licence and facilities available with the manufacturer.

 

Q6. What is the method of confirming the reliability of the pharma manufacturer?

 

Request a copy of the manufacturing license, list of approved products, GMP and ISO certification, certificate samples, and the quality agreement. The company’s adherence to the revised Schedule M is essential. If possible, do an audit of the premises and talk to their customers.

 

Q7. What is the time required for launching products through third party manufacturing?

 

It varies depending on documentation, artwork clearance, availability of raw materials and dosage form. Oral solids tend to be launched faster than injectable dosage forms. Get from your manufacturing company a written product-specific timeline while requesting a quotation.

 

Conclusion

 

Third Party Pharma Manufacturing provides a practical approach for getting to the market for pharma brands without large initial investments, on the condition that they select the right partner and establish the right legal structure. Licenses and product approvals, a documented quality system, product-by-product quotation comparison, everything agreed in writing, an audit, and a narrow portfolio are key to success.
 

Looking for a Third Party Pharma Manufacturing Partner? Explore Systole Remedies' manufacturing services and contact the team to discuss your requirements.
 

Phone No: +91-9828506600

Email ID: newbusiness@systoleremedies.com

Address: Village Ogli, Kala Amb, District Sirmaur, Himachal Pradesh 173030