To get started with a third-party manufacturing service, you generally need documents such as a business incorporation certificate, a GST number, bank account details, a drug license, and formula details.
Now you must be wondering what the importance of these “papers” is and where to get them from. That’s why we have come up with this guide on the documents required for third-party pharma manufacturing. Let’s get started.
Why Documents Matter in Third-Party Pharma Manufacturing
Documents like a GST number and a drug license prove that your brand has the legal right to market and distribute the medicines. It prevents unauthorised production of fake or substandard medicines. Also, it ensures full traceability through the supply chain.
Each state drug authority and the Central Drugs Standard Control Organisation (CDSCO) require proof that the product is manufactured safely, legally and by a qualified manufacturer. Without the proper paperwork, a batch can be delayed at customs, turned away by a distributor, or flagged during an inspection.
Documentation also protects both sides in a commercial sense. In case of a dispute concerning quality, payment or product rights, it is resolved by a signed agreement. Most of the time, skipping this step to save time ends up costing more later.
What is Third-Party Medicine Manufacturing?
It is an agreement where a brand owner hires a licensed manufacturer to manufacture medicines under the brand owner’s own label. The brand owner does not require a factory, machinery or a manufacturing license. The manufacturer is responsible for production, quality control and packaging, while the brand owner is responsible for branding, distribution and sales.
That sounds easy. But medicines are a regulated product, so both parties have to prove they are compliant at each step. That’s where documentation comes in.
Pharma Manufacturing Documents: Quick Checklist
| Document | Why You Need It | Who Issues It |
|---|---|---|
| Certificate of Incorporation / Partnership Deed | Sets up your legal entity | MCA Portal / Registrar of Firms |
| GST Registration Certificate | Tax ID for invoicing | GST Portal |
| PAN Card (company & directors) | Required for tax & banking | Income Tax Dept (NSDL/UTIITSL) |
| MSME / Udyam Registration | Unlocks MSME benefits | Udyam Registration Portal |
| Bank Account Details & Cancelled Cheque | Verifies for manufacturer onboarding | Your bank |
| Manufacturing Agreement | Locks in pricing, MOQs, quality, recall liability | Brand owner & manufacturer (legal counsel) |
| Non-Disclosure Agreement | Protects your formula & trade secrets | Legal / IP counsel |
| Loan Licence Agreement | Needed if you hold a licence but no plant | State Licensing Authority |
| Product Supply Agreement | Sets delivery terms & legal liability | Brand owner & manufacturer |
| Master Formula Record (MFR) | Documents the manufacturing process & formula | In-house R&D / manufacturer’s tech team |
| Stability Data | Proves shelf-life & quality under stress | Testing lab / analytical R&D |
| Product Labelling & Artwork | Packaging cleared under Drugs & Cosmetics Rules | Design team & regulatory consultant |
| Certificate of Analysis (CoA) | QC report for raw materials & finished goods | Manufacturer’s QC lab |
| Product Registration / Approval | Needed for new or fresh drug approvals | State Licensing Authority / CDSCO |
| Drug Licence (Wholesale or Retail) | Legal permission to sell in India | State Drug Control / FDCA |
| WHO-GMP Certification | Confirms the plant meets WHO standards | State / Central Drug Controller |
| Special Category Permits | Covers injectables, cytotoxic & other special lines | State Drug Control / CDSCO |
| AYUSH Certificate | Required for herbal / ayurvedic products | Ministry of AYUSH |
| Batch CoA | Test report for every commercial batch dispatched | Manufacturer’s QC department |
| Veterinary Product Approvals | Covers animal healthcare products | Dept of Animal Husbandry & Dairying |
Documents Required for Third Party Pharma Manufacturing
Business Registration
Before anything else, your business needs to exist on paper. You’ll need:
- Certificate of Incorporation (for private limited companies) or partnership deed (for partnerships)
- GST registration certificate
- PAN card of the company and its directors or partners
- MSME or Udyam registration, if applicable
- Bank account details and a cancelled cheque
These establish that you’re a legitimate business entity, which every manufacturer will ask for before signing on.
Everything you need to set up and run third-party pharma manufacturing in India, at a glance.
Agreement and Contract Documents
This is the legal backbone of the entire arrangement. You’ll need:
- A manufacturing agreement between the brand owner and the manufacturer, spelling out pricing, minimum order quantities, quality standards, and timelines
- A non-disclosure agreement, if the formulation is proprietary
- A loan licence agreement, in cases where the brand owner holds a licence but doesn’t own a factory
- Product supply agreement covering delivery terms and liability
A good agreement also covers what happens if a batch fails quality checks and who bears the cost of a recall. Vague contracts can cause more problems than missing documents do.
Product-Related Documents
For each product you want manufactured, you’ll need:
- Product formulation or master formula record
- Stability data, especially for new formulations
- Product labelling and artwork, cleared as per Drugs and Cosmetics Rules
- Certificate of Analysis (CoA) for raw materials and finished goods
- Product registration or approval, if the formulation requires fresh approval from the drug authority
A Drug Licence
To sell pharma products in India, you need a valid Drug Licence. It can be a wholesale or retail licence, based on how you plan to sell.
If you don’t hold one yet, most third-party pharma manufacturing firms can help you get it. Your state’s Drug Control office issues the licence. It often takes a few weeks. Apply early. Don’t wait until your product list is final.
Papers You Need From Your Manufacturer
Make sure to ask for copies of the documents from your manufacturers as given below:
- WHO-GMP certifications
- Permits/approval for making certain products like injectables
- AYUSH certificate for herbal products
- Batch CoA
- Documents for manufacturing vet products
Choosing the Best Pharma Third Party Manufacturing Company
Documents are only useful if the company that creates them can be trusted. Before signing anything, ensure the manufacturer has an updated WHO-GMP licence, experience with similar formulations and is transparent about batch timelines. Ask for references from previous clients. Regardless of how competitive their pricing looks, a manufacturer who is cagey about sharing licence copies or past client details is a red flag.
How Lifevision Healthcare Supports New Partners
If you are new to the pharma business, it is hard to get this paperwork right the first time. We at Lifevision Healthcare guide new brands through the documentation process step by step, from checking manufacturing licences and product approvals to reviewing agreements before signing.
FAQs
Q1: Why do I need certain paperwork to opt for third-party manufacturing services?
A: Without the proper paperwork, a batch can be delayed at customs, turned away by a distributor, or flagged during an inspection.
Q2: How much time is required for preparing all documents?
A: Four to eight weeks on average if product approvals or fresh labelling clearances are needed.
Q3: Can the same process be used to manufacture Ayurvedic or nutraceutical products?
A: Yes, but the licenses are different. Ayurvedic products require an Ayurvedic manufacturing licence as they fall under an AYUSH permit. Nutraceuticals are not under the Drugs and Cosmetics Act; they fall under FSSAI.
Q4: What if my manufacturer’s GMP certificate is expired during the contract?
A: Always check the validity period of the certificate before signing a long-term agreement.
Q5: How to check the license of a pharma third party manufacturing company?
A: You can cross-check the manufacturing licence number on the website of the respective State Drug Control Authority or request the manufacturer to provide you with a certified copy.
Q6: Do I need a written agreement or can we work on verbal terms?
A: Of course, yes. It’s very important. Without it, it’s very difficult to resolve the dispute concerning quality or payment. Be sure to check the validity period of the certificate before signing a long-term agreement.
Q7: Can a third-party manufacturer help me with documents?
A: Yes, most good third-party pharma manufacturers like Life Vision Healthcare help their new clients with paperwork. After all, securing documents is an important part of getting started with any third-party pharma manufacturing.