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Updated July 2026

Pharma Guide · Buyer Checklist

6 Things to Check Before Choosing a Third-Party Manufacturer in India

Third-party manufacturing lets you market pharmaceutical products under your own brand while a WHO-GMP certified manufacturer handles production — but only if the manufacturer can actually issue export documentation in your brand name. Six specific checks, including this one specific detail most buyers overlook, determine whether this model works for your business or stalls at the documentation stage.

  • 10 companies reviewed
  • WHO-GMP verified criteria
  • 14 min read

  • WHO-GMP Status

    Active cert — not expired

  • Sample COA

    real batch data, 24 hours

  • DCGI Approvals

    molecule-level approval

  • COPP on file

    for your target country

  • Grade A/B cleanroom

    sterile injectable

  • Written by

    Bhavya Bhambani

    Content Writer, 9M India

  • Reviewed by

    Manish Agrawal

    MD, 9M India Limited

  • Fact-checked by

    Manish Shah

    Plant Head, 9M India

About 9M India Limited — examples and standards referenced in this guide

9M India Limited is a WHO-GMP certified pharmaceutical manufacturer established in 2009, located in Birkoni, District Mahasamund, Chhattisgarh. The company offers third-party pharma manufacturing across sterile injectables, capsules, tablets, eye drops, syrups, and topicals for international buyers, with export documentation including COPP issued referencing the buyer’s own brand name. This guide uses 9M India’s documentation standards as the benchmark — COPP, FSC, COA, and stability data available within 24 hours, exports to 15+ countries.

Why these 6 checks matter — industry context

India’s third-party pharmaceutical manufacturing market is estimated at ₹12,000–15,000 crore annually and growing at 12–15% (industry estimate, 2024), serving domestic branded generic companies, hospital chains, and international importers seeking to market quality pharmaceutical products under their own brand without owning manufacturing infrastructure. A verification challenge specific to third-party manufacturing: not every WHO-GMP certified manufacturer has the documentation systems set up to issue COPP and export paperwork referencing a buyer’s brand name rather than their own — this is a genuine operational capability gap, not a formality. These six checks are the practical buyer’s verification framework for this specific sourcing model.

Brand-Name COPP

Confirm the manufacturer can issue COPP in YOUR brand/product name

This is the single detail that determines whether third-party manufacturing actually works for your registration.

#1 of 6

For export drug registration, the Certificate of Pharmaceutical Product (COPP) must reference your specific product name and your company as the marketing authorisation holder. Confirm the manufacturer has direct, demonstrated experience issuing COPP for third-party brands — not every manufacturer’s documentation systems are set up for this smoothly, even when they’re genuinely WHO-GMP certified.

Why this is a genuine capability gap, not a formality
Some manufacturers primarily issue documentation under their own brand and have limited experience supporting third-party brand registration specifically — this shows up as friction, delay, or confusion when a buyer actually requests brand-specific COPP, even after the manufacturing relationship is otherwise agreed.

How to verify - step by step

  • Ask directly: “Can you issue a COPP referencing my brand/product name?” Not the manufacturer’s own brand — explicitly yours.

  • Request a sample or template of a previous third-party COPP: Evidence they’ve actually done this before, not just theoretical willingness.

  • Confirm the process and typical timeline for brand-specific COPP issuance: This can differ from their standard COPP process.

  • Ask how many third-party brands they currently support: A higher number signals more mature documentation systems for this specific need.

Why this check matters for export
Without a COPP correctly referencing your brand name, your drug registration application cannot proceed — this single documentation detail can stall an otherwise sound third-party manufacturing relationship indefinitely.

Red flags to watch for

Manufacturer hesitates or is vague when asked about brand-name COPP specifically · No prior example or reference of third-party brand COPP issuance · Significantly longer timeline quoted for brand-specific vs standard COPP · Manufacturer suggests using their own brand name “for now”

From Industry Rankings

See how the top 10 third-party manufacturing companies in India compare on brand-name COPP support

Our editorial ranking compares the top 10 third-party pharma manufacturing companies in India across all 6 criteria in this guide — brand-name COPP capability, WHO-GMP scope, DCGI approvals, MOQ fit, agreement process, and export track record.

See the full ranking

WHO-GMP Scope

Confirm WHO-GMP certificate covers the dosage form you need manufactured

Sterile injectables and ophthalmic products require Grade A/B cleanroom certification specifically — not every WHO-GMP facility holds it.

#2 of 6

WHO-GMP certification scope is specific to the dosage forms inspected and approved. Confirm the manufacturer’s certification explicitly covers your required dosage form before proceeding — assuming coverage without checking the scope line is a common and avoidable mistake.

What is WHO-GMP certification in India?
WHO-GMP is issued by CDSCO following an on-site inspection against World Health Organization Good Manufacturing Practice guidelines, and is time-limited, requiring periodic re-inspection. Sterile dosage forms (injectables, ophthalmics) require additional Grade A/B cleanroom validation within the same certification framework.

How to verify — step by step

  • Request the actual certificate document: On CDSCO letterhead, with authorised signature and stamp.

  • Check the scope line for your specific dosage form: Sterile forms require Grade A/B cleanroom certification specifically.

  • Check the expiry date: Certificates are time-limited and require periodic re-inspection.

  • Cross-verify on the CDSCO database: At cdsco.gov.in using the manufacturer’s licence number.

Why this check matters for export
Import regulators require the submitted WHO-GMP certificate to explicitly cover the dosage form being registered under your brand — a mismatch here delays your registration regardless of how strong the underlying manufacturing relationship is.

Red flags to watch for

Certificate scope doesn’t list your required dosage form · Manufacturer assumes coverage without showing the scope line · Certificate older than 3 years without re-inspection documentation · Cannot provide certificate within 24 hours

DCGI Approval

Confirm DCGI manufacturing approval is already in place for your specific molecule

Legal manufacture cannot begin without this — regardless of how ready the brand relationship is.

#3 of 6

The manufacturer must hold DCGI approval for your exact molecule, strength, and dosage form before any legal manufacture can begin. Confirm this directly rather than accepting a general assurance of capability — this is the same underlying legal requirement whether the product is sold under the manufacturer’s own brand or yours.

Why this matters equally in third-party relationships
A third-party arrangement doesn’t change the underlying regulatory requirement — DCGI approval must exist for the specific molecule regardless of whose brand appears on the label. Confirm this is genuinely in place, not something being pursued in parallel with your registration timeline.

How to verify — step by step

  • Request the DCGI licence for your exact molecule: Strength and dosage-form specific.

  • Confirm approval is currently active, not pending: A manufacturer offering to manufacture “while approval is in process” is a serious red flag.

  • Verify the licence details match your exact requirement: Not a similar molecule or different strength.

  • Ask how the DCGI approval interacts with third-party brand registration: Confirm there’s no additional layer of approval needed specifically for third-party arrangements.

Why this check matters for export

A product manufactured without correct DCGI approval cannot legitimately be included in an export drug registration dossier, under any brand name — this is a foundational legal requirement, not a paperwork detail.

Red flags to watch for

Manufacturer offers to produce your molecule without existing DCGI approval · “Approval in process” presented as sufficient to begin · DCGI licence details don’t match your exact molecule or strength · Confusion about how DCGI approval interacts with third-party brand arrangements

From the Compare section

Contract vs third-party manufacturing — what's the actual difference?

In India, the terms are often used interchangeably. Technically, third-party manufacturing (loan licence) typically refers to arrangements under the buyer’s brand, while contract manufacturing refers to production to the buyer’s specification. Both require WHO-GMP certification and the same core export documentation.

Complete COA
WHO-GMP certified facility

Sterility · Bacterial endotoxin · Particulate matter · Assay · pH — all required and documented per WHO-GMP batch release procedure.

  • All tests mandatory for batch release
ISO 9001 only facility

Sterility · Bacterial endotoxin · Particulate matter · Assay · pH — all required and documented per WHO-GMP batch release procedure.

  • Pharma-specific tests not mandated
Read Full Comparison

MOQ Fit

Confirm MOQ is compatible with your third-party programme's actual volume

A mismatch here is the most common reason third-party manufacturing relationships stall before they start.

#4 of 6

Confirm the manufacturer’s minimum order quantity matches realistic volumes for your target market and brand launch plan. Third-party programmes often start smaller than established brand volumes — ensure the manufacturer’s MOQ structure accommodates a realistic launch quantity, not just their standard commercial minimum.

Why MOQ conversations need extra care in third-party arrangements

A new brand entering a market typically can’t commit to the same volumes as an established distributor with proven sell-through. Ask specifically whether the manufacturer has flexibility for a smaller launch order with a growth commitment, versus a rigid one-size MOQ regardless of relationship stage.

How to verify — step by step

  • State your realistic launch-stage volume honestly: Not an optimistic future projection — your actual near-term plan.

  • Ask if launch-order flexibility exists for new third-party brands: Some manufacturers structure this differently than standard commercial MOQ.

  • Confirm MOQ per dosage form if your brand spans multiple products: Different products may carry different minimums.

  • Discuss a realistic volume growth path: Understanding how MOQ terms might evolve as your brand scales.

Why this check matters for export
An MOQ that doesn’t match realistic launch-stage volumes can stall a third-party brand relationship before it generates enough sales history to justify larger orders — creating a chicken-and-egg problem worth addressing directly upfront.

Red Flags to Watch For

Rigid MOQ with no flexibility discussion for new brand launches · MOQ significantly exceeds realistic first-year volume for a new market entrant · No willingness to discuss a phased volume growth approach · Inconsistent MOQ figures quoted across conversations

Agreement Process

Confirm a documented manufacturing/loan-licence agreement process exists

Ask what a standard third-party agreement actually covers — IP protection, exclusivity, and quality accountability specifically.

#5 of 6

Ask what a standard third-party manufacturing agreement looks like with this manufacturer, and what it explicitly covers — IP protection for your formulation, exclusivity terms if relevant, and quality accountability structure. A manufacturer wit-0-hout a clear, standard agreement process represents a coordination risk for your brand relationship.

What a genuine third-party agreement process should include
Beyond basic commercial terms, look for clarity on formulation confidentiality, what happens if quality issues arise, how pricing changes are communicated, and whether there are any exclusivity commitments in either direction. A manufacturer who has done this before will have clear, consistent answers; one who hasn’t will improvise answers during your conversation.

How to verify — step by step

  • Ask to see a sample or template third-party manufacturing agreement: Not just a verbal description — an actual document structure.

  • Confirm IP/formulation confidentiality terms: How your specific formulation details are protected.

  • Ask about quality accountability structure: What happens procedurally if a batch fails to meet specification.

  • Discuss exclusivity terms if relevant to your brand strategy: Whether either party can be restricted from working with others in your category/market.

Why this check matters for export
A third-party manufacturing relationship is inherently ongoing and higher-trust than a one-time purchase order — the absence of a clear, documented agreement framework is a structural risk to your brand’s supply continuity.

Red Flags To Watch For

No sample or template agreement available to review · Vague or inconsistent answers about IP/confidentiality protection · No clear process described for quality issue resolution · Manufacturer discourages putting terms in writing

Export References

Ask for export references specifically for third-party branded products

General export experience under the manufacturer's own brand doesn't transfer automatically to third-party brand support.

#6 of 6

Confirm the manufacturer’s export history and references cover third-party brand export registration specifically — not just their own or their major clients’ products. This distinction matters because the documentation flow (see Check 1) is genuinely different for third-party arrangements.

Why this reference check needs to be specific
A manufacturer with extensive export experience under their own brand may still be relatively new to supporting third-party brand registration — these are related but distinct capabilities. Ask pointed questions to confirm which kind of experience you’re actually evaluating.

How to verify — step by step

  • Ask specifically for third-party brand export references: Not general export history — brand-specific relationships.

  • Request to speak with an existing third-party brand client if possible: Direct reference conversations reveal more than documentation alone.

  • Ask how many active third-party brands the manufacturer currently supports: A track record signals mature, tested processes.

  • Confirm the reference covers a market and dosage form similar to yours: Relevance matters more than volume of references.

Why this check matters for export
A reference check that confirms general export capability but not third-party brand support specifically can give false confidence going into a relationship that later stalls on the brand-name COPP issue covered in Check 1.

Red Flags To Watch For
References provided are all for the manufacturer’s own brand, not third-party · Unwillingness to connect with an existing third-party brand client · Very limited or no track record of third-party brand relationships · References don’t cover a market or dosage form relevant to your situation

More Pharma Guide

Frequently asked questions

  • What is third-party pharmaceutical manufacturing in India?

    Third-party manufacturing (also called loan licence manufacturing) is a model where a WHO-GMP certified manufacturer produces finished pharmaceutical products for another company’s brand under a manufacturing agreement. The manufacturer holds the DCGI licence; the buyer holds the marketing authorisation and brand rights in their target country.

  • Can a third-party manufacturer issue COPP referencing my brand name?

    Yes, if the manufacturer has the documentation systems and CDSCO relationship to support it — but confirm this explicitly rather than assuming. Some manufacturers primarily issue documentation under their own brand and are less experienced supporting third-party brand registration specifically.

  • What is the difference between third-party and contract manufacturing?

    In practice, the terms are often used interchangeably in India. Technically, third-party manufacturing typically refers to loan-licence arrangements under the buyer’s brand, while contract manufacturing refers to production to the buyer’s specification. Both require WHO-GMP certification and the same core export documentation.

  • What documents does a third-party manufacturer provide for export?

    WHO-GMP Certificate, DCGI Manufacturing Licence, COPP from CDSCO referencing your product/brand name, Free Sale Certificate, COA per batch, Stability Data, Manufacturing/Loan Licence Agreement, and CTD/ACTD Dossier.

    British Pharmacopoeia 2024

  • What is the minimum order quantity for third-party pharma manufacturing?

    MOQ typically ranges from 10,000 units (topicals) to 10 lakh units (tablets/capsules) depending on dosage form. These MOQs are often negotiable for launch-stage third-party brand orders — discuss this directly rather than assuming a fixed minimum applies.

9M India — passes all 6 checks

Ready to verify 9M India against your checklist?

WHO-GMP certificate, DCGI approval, sample COA, COPP, stability data — all available within 24 hours of your first enquiry.

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WHO-GMP certified · DCGI approved · 15+ export countries · Birkoni, Chhattisgarh · Est. 2009

By Formulation Type
Tablets Capsules Granules & Powders Syrups Suspensions Solutions Ointments Creams Gels Injections Eye Drops Ear Drops External Liquid Dosage
By Therapeutic Segment
Antibiotics Pain Management Cardiovascular Diabetic Care CNS / Neurology Gastrointestinal Respiratory Dermatology Vitamins & Minerals Ophthalmic Paediatrics Anti Infective

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