7 Things to Check before Finalizing a Third Party Medicine Manufacturer
- Pharma Vends
- July, 22, 2025
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India is the world’s largest provider of pharma medicine, accounting for more than 20% of worldwide exports. In this, there is a huge impact and role of the domestic need for affordable, high-quality pharmaceuticals, which continues to rise as the population grows, lifestyle diseases become more prevalent, and rural healthcare expands.
As a result, brands concentrate on marketing and distribution, while manufacturing is outsourced to specialized units, resulting in increased third-party manufacturing growth. Moreover, new and existing pharmaceutical companies prefer low capital expenditures.
This is also because building a GMP-certified facility costs crores of rupees; it is quicker and faster to outsource to an experienced third-party business. Thus, medicines and healthcare product companies can easily maintain their investments free for branding, sales force, pcd franchise networks, and state expansion.
However, the third-party medicine manufacturing industry also gets huge support from government schemes and infrastructure clusters. This includes Baddi (HP), Uttarakhand, Gujarat, Telangana, and even Maharashtra which feature robust pharmaceutical parks for this pharma sector growth. Therefore, various states of India provide tax breaks, plug-and-play infrastructure, trained labour, and logistics centres.
Along with this, India’s top schemes, such as Make in India, oil for pharma, and bulk medicine parks, improve capacity and competitiveness. One of the other important things is that many third-party manufacturers in India are WHO-GMP/USFDA/EU-GMP certified, enabling exports to regulated and semi-controlled markets. Therefore, because of this, today global purchasers benefit from low costs, high volume, and skilled production services of third-party manufacturing services in India rather than producing locally.
Consequently, the third-party medication manufacturing industry in India is expected to expand further due to demand for inexpensive generics and specialty medications. Also, this business is ideal for startups that have only a few assets to run their medicine business.
Factors to Consider before Selecting a Third-Party Medicine Manufacturer for Your Pharma Business
Certification and Compliance:
You also should check for WHO-GMP, ISO, DCGI, and other quality certifications. Then, try to ensure that they adhere to good manufacturing practices (GMP), this is essential for trust and legal compliance. Also, if you intend to export to regulated markets, ensure that they have USFDA or EUGMP certification.
Product Portfolio and Technical Capabilities:
Always try to confirm that chosen companies have good experience with your product (tablets, ointments, syrups, injectables, etc.). Moreover, for delicate products (such as tacrolimus ointment or biotech medicines), be sure they have proven formulations, stability data, and specialized facilities. However, request samples to ensure product quality.
Production Capacity and Scalability:
As your firm grows, the third-party medicine manufacturer in India always ensures that they can easily handle both your initial and future bulk orders. After that, you can find out the batch size, lead time, and turnaround and also determine whether they can manage urgent requests during peak demand.
Packaging and Customization:
Examine their packaging options, do they provide private labeling, custom design, and export-ready packaging? Then, examine samples of tubes, bottles, cartons, and labels for quality and also ensure they adhere to regulatory labeling standards for both home and foreign markets.
Quality Control and Testing:
Verify that third-party manufacturing pharma companies have an in-house quality control lab or collaborate with approved labs. Then, try to examine how they manage raw material testing, in-process inspections, final batch testing, and stability data. After all this, request recent CAOs (certificates of analysis).
Transparent Terms and Documentation:
One of the most important elements you should discuss is the pricing structure, payment periods, hidden costs, and taxes up front. After this, you should confirm that they provide manufacturing agreements, non-disclosure agreements (where applicable), and required licenses. This is also included to ask about product registration assistance if you intend to export.
Market Reputation and Client References:
Investigate their track record and customer reviews, and also ask for references; genuine producers will not hesitate. If possible, you can also visit their facility to observe hygiene, storage, personnel strength, and SOPs in action.
List of the Necessary Legal Documents to get Third-Party Manufacturing Services in India
When working with a third-party medicine manufacturer in India, you must have the proper legal documentation. Thus, here we have given a comprehensive list of the necessary legal documents to ensure seamless, compliant, and risk-free operations:
- Drug License:
- GST Registration:
- 3rd Party Manufacturing Agreement:
- Trademark Registration:
- Non-disclosure Agreement (NDA):
- Product Approval Documents:
- Quality Assurance and Batch Release Certificate:
Who needs it?
Pharma Company Owner
Pharma Distributor/Wholesaler/Trader
Doctor or a Medical Representative
Why? The Drugs and Cosmetics Act of 1940 requires that pharmaceutical items be legally marketed or distributed in India.
Also, depending on your business strategy, you can obtain a wholesale drug license (Forms 20b & 21b) or a retail license.
You must have a valid GST number that is used for invoicing, tax compliance, and claiming input tax credits.
This is a legally binding agreement between you and the manufacturer. This document includes product names and specifications, batch sizes and manufacturing schedules, quality standards, pricing terms, intellectual property and confidentiality agreements, delivery dates and penalties, and dispute resolution procedures.
If you market under your brand name, you should register it with the Indian trademark registry. This particularly prevents your brand from being copied.
Some businesses in India are well known to sign a separate contract with the manufacturer to safeguard this, including the formulas, product descriptions, pricing, artwork, and marketing strategies. After this, they also maintain confidentiality and limit the exploitation of your valuable information.
These are required for each product to be manufactured.
Formulation Details
Packaging Artwork Approvals (Labels/Cartons)
Export required NOC or Product Registration
Manufacturers should provide:
Each batch will have its certificate of analysis (COA)
A batch release certificate certifying conformance to specifications
These procedures verify that the product has been tested and is safe to sell.
Conclusion
Consequently, we have given some important factors while you invest in any third-party medicine manufacturer in India. Also, we have given some required details of the documents you need as customers. Thus, Pharmavends is your one-stop location to get all the benefits and services to grow your business.
