Contact Us Contact Us Contact Us

Updated July 2026

Pharma Guide · Buyer Checklist

6 Things to Check Before Choosing a Topical (Ointment/Cream) Manufacturer in India

India’s pharmaceutical contract manufacturing sector is valued at approximately $2.8 billion and growing at 10–12% annually (Pharmexcil, 2024). But the single most common sourcing mistake is approaching a regulated-market CDMO built for multi-million-unit US and EU orders when your actual programme needs 1–5 lakh units for Africa or the Middle East. Six specific checks help you avoid that mismatch entirely.

  • 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 contract manufacturing across sterile injectables, capsules, tablets, eye drops, syrups, and topicals for international buyers at 1–10 lakh unit MOQs — deliberately sized for Africa, Middle East, and CIS export programmes rather than regulated-market volumes. 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 contract manufacturing sector serves two distinct buyer profiles with very different needs: regulated-market CDMOs built for US/EU generic pharma companies requiring multi-million-unit batches, and WHO-GMP certified manufacturers structured for Africa, Middle East, and CIS buyers at 1–10 lakh unit programme sizes. A verification challenge specific to contract manufacturing: buyers frequently approach the wrong category of manufacturer entirely, discovering the MOQ mismatch only after significant time invested in a relationship that was never going to fit their programme size. These six checks are the practical buyer’s verification framework, drawn from real sourcing patterns across Africa and Middle East export programmes.

MOQ Fit

Match the manufacturer's minimum batch size to your actual programme size

This single question — asked first — filters out most mismatches before any further discussion.

#1 of 6

Large regulated-market CDMOs commonly require batch sizes in the millions of units — fundamentally incompatible with a 1–5 lakh unit Africa or Middle East export programme. Confirm the manufacturer’s minimum batch size before any further discussion of pricing, documentation, or timelines.

Why this mismatch happens so often
Buyers researching “top pharma contract manufacturers in India” frequently surface large, regulated-market-focused companies first, simply because they’re the most visible. These companies are not wrong choices in the abstract — they’re wrong for a 1–5 lakh unit programme specifically, and confirming MOQ compatibility upfront saves significant wasted time on both sides.

How to verify - step by step

  • Ask directly: “What is your minimum batch size for [dosage form]?” Before discussing anything else — molecule, pricing, or timeline.

  • State your actual programme volume upfront: Don’t wait to be asked — volunteering your real numbers gets a faster, more honest answer

  • Ask if MOQ varies by dosage form: Injectables, tablets, and syrups often carry different MOQs even at the same manufacturer.

  • Confirm whether MOQ is negotiable for repeat orders: Some manufacturers flex on a first order if a long-term relationship is likely.

Why this check matters for export
A mismatch discovered late in the relationship — after formulation discussions, sample requests, or documentation reviews — wastes months. Confirming MOQ fit as the first question protects your timeline more than any other single check in this guide.

Red flags to watch for

Manufacturer avoids stating a clear minimum batch size · MOQ quoted is wildly inconsistent between conversations · Manufacturer suggests you “just try” without confirming feasibility first · No distinction made between MOQ for different dosage forms

From Industry Rankings

See how the top 10 contract manufacturing companies in India compare on MOQ and documentation speed

Our editorial ranking compares the top 10 contract manufacturing pharma companies in India across all 6 criteria in this guide — MOQ fit, WHO-GMP scope, DCGI approvals, documentation turnaround, cross-dosage capability, and export track record.

See the full ranking

WHO-GMP Scope

Confirm WHO-GMP certificate covers your specific required dosage form

A contract manufacturer may hold WHO-GMP for solid oral forms but not for sterile injectables or ophthalmic products.

#2 of 6

WHO-GMP certification scope is specific to the dosage forms inspected and approved. Confirm the certification explicitly covers the dosage form you need manufactured before proceeding further — this is especially important for sterile products, which carry additional Grade A/B cleanroom requirements.

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. It is distinct from ISO 9001, which is not accepted for pharmaceutical export drug registration.

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 injectables and ophthalmics 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 — assuming coverage without checking the scope line is a common and avoidable mistake.

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 approval for your specific molecule is already in place

A manufacturer agreeing to produce your molecule without existing DCGI approval is offering to manufacture outside their licence.

#3 of 6

Contract manufacturers must hold DCGI manufacturing approval for each molecule they produce commercially. A manufacturer agreeing to “add” your molecule without existing approval is offering something legally and regulatorily risky for your drug registration, not a normal accommodation.

Why this distinction matters more in contract manufacturing specifically
Contract manufacturing relationships often move faster than standard sourcing — buyers are eager to start, and manufacturers eager to win the business. This creates pressure to skip verifying DCGI approval status, which is exactly when it matters most to slow down and confirm.

How to verify — step by step

  • Request the DCGI licence for your exact molecule: Strength and dosage-form specific — before any formulation discussion proceeds.

  • Ask explicitly if approval is pending, not yet granted: A manufacturer offering to manufacture “while approval is in process” is a red flag, not a convenience.

  • Confirm the approval covers your specific requirement: Not just a similar molecule or a different strength.

  • Verify the licence is currently active: Not expired or under renewal.

Why this check matters for export

A product manufactured without the correct DCGI approval cannot legitimately be included in an export drug registration dossier — this isn’t a paperwork technicality, it’s a fundamental legal requirement for the manufacture itself.

Red flags to watch for

Manufacturer offers to produce your molecule without existing DCGI approval · “Approval in process” presented as equivalent to approval granted · DCGI licence details don’t match your exact molecule or strength · Manufacturer discourages you from requesting to see the licence directly

From the Compare section

CDMO vs contract manufacturer — which type of partner do you actually need?

A CDMO provides formulation development plus manufacturing. A contract manufacturer produces an already-established formulation without development work. For buyers with an existing molecule list, a straightforward contract manufacturer is usually sufficient and avoids unnecessary CDMO cost and complexity.

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

Documentation Speed

Test documentation turnaround time before signing anything

Send a formal request and time the response — this reveals more about regulatory readiness than any sales conversation.

#4 of 6

Send a formal documentation request for the WHO-GMP certificate, DCGI licence for your molecule, a sample COA, and COPP status for your target market. A commercially ready contract manufacturer responds within 24 hours — longer than 48 hours signals documentation system gaps that will slow your entire programme.

What slow turnaround actually reveals
Documentation delays typically indicate one of several underlying issues: documents are prepared by a third-party regulatory consultant rather than maintained in-house, the product isn’t genuinely in regular commercial production, or the facility lacks a proper document management system. Any of these represents a real supply chain risk for a contract manufacturing relationship specifically, where you’ll depend on this manufacturer repeatedly over time.

How to verify — step by step

  • Send a documentation request by email, note the time sent: Ask for WHO-GMP certificate, DCGI approval confirmation, and a sample COA for one molecule.

  • Note whether response arrives same business day: A benchmark manufacturer responds by end of business.

  • Follow up requesting COPP and stability data: These require more preparation but should arrive within 24-48 hours for existing export products.

  • Treat the entire exchange as a preview of the ongoing relationship: Not just a one-time test — this is how future requests will likely be handled too.

Why this check matters for export
A contract manufacturing relationship is inherently ongoing — a manufacturer who is slow with documentation before you’ve even signed an agreement will not improve once the relationship is locked in.

Red Flags to Watch For

No response within 48 hours to a documentation request · Documents arrive incomplete or as generic templates · Manufacturer asks for a purchase order before providing any documentation · Communication requires excessive follow-up to get a straight answer

Cross-Dosage Capability

Confirm cross-dosage-form capability under one roof, if your programme needs it

One WHO-GMP certification covering multiple dosage forms simplifies your documentation meaningfully.

#5 of 6

If your programme spans multiple dosage forms — injectables, tablets, syrups — a manufacturer offering all of them under one WHO-GMP certification simplifies documentation and consolidates your COPP applications, compared to managing multiple separate manufacturing relationships.

Why single-source capability reduces operational risk
Each additional contract manufacturer in your supply chain means an additional relationship to manage, an additional set of documentation to track, and an additional point of potential failure. Where a single manufacturer is genuinely capable across your required dosage forms — not just claiming capability — consolidating reduces this meaningfully.

How to verify — step by step

  • List your full dosage-form requirement upfront: Injectable, tablet, capsule, syrup, topical — whichever combination your programme needs.

  • Confirm DCGI approval exists for each dosage form separately: Cross-dosage capability requires separate approval per form.

  • Ask whether documentation can be consolidated across dosage forms: One relationship, coordinated COPP applications, where genuinely supported.

  • Verify quality consistency claims across dosage forms: Ask for COA examples from each dosage form, not just the one you’re most focused on.

Why this check matters for export
Fewer manufacturer relationships means fewer COPP applications and fewer points of documentation failure across your full product programme’s registration process.

Red Flags To Watch For

Manufacturer claims broad capability without dosage-form-specific DCGI approval for each · Quality documentation is strong for one dosage form but weak for others · No consolidated documentation process across dosage forms · Inconsistent responsiveness depending on which dosage form is being discussed

Export References

Ask for export references and COPP for your specific target country

An existing COPP for your target market shortens registration timelines by 6–12 months.

#6 of 6

A Certificate of Pharmaceutical Product (COPP) confirms a specific product is authorised for manufacture and sale in India. Confirm the manufacturer holds an active COPP for your specific target market — this is a strong indicator of genuine, tested export readiness, not just theoretical capability.

What is a COPP (Certificate of Pharmaceutical Product)?
A COPP is issued under the WHO Certification Scheme by CDSCO for products manufactured by a DCGI-licensed manufacturer at a WHO-GMP certified facility. For topicals specifically, confirm the COPP references your exact molecule, combination, and packaging format. (WHO Technical Report Series No. 986, Annex 10)

How to verify — step by step

  • Ask “Have you previously exported this topical product to [country]?” — and confirm it covers your exact molecule and dosage form.

  • Ask whether COPP can be issued referencing your brand name: Important if this is a contract manufacturing arrangement under your own label.

  • Ask “Can you provide a CTD or ACTD dossier?” — export-experienced manufacturers typically hold ready dossiers.

  • Request references from other buyers in similar markets: A genuine contract manufacturer will have referenceable relationships to point to.

Why this check matters for export
Dossier review queues in Africa and the Middle East are long; an existing COPP eliminates the initial 30–90 day waiting period entirely, and confirms the manufacturer has genuinely navigated export registration before, not just claimed the capability.

Red Flags To Watch For
Vague answers about prior export experience · No clarity on whether COPP can be issued under the buyer’s brand name · No CTD/ACTD dossier despite claimed export history · Unwilling to provide any buyer references

More Pharma Guide

Frequently asked questions

  • What is the typical MOQ for contract manufacturing in India?

    Creams and ointments are emulsions or semi-solid bases that can physically separate, change texture, or liquefy under heat stress in ways that don’t necessarily show up in a standard chemical assay. Tropical climate storage during shipping and warehousing makes this a real, not theoretical, risk.

  • What is the difference between a CDMO and a contract manufacturer?

    A CDMO (Contract Development and Manufacturing Organisation) provides both formulation development and manufacturing services. A contract manufacturer produces an already-established formulation without development work. For buyers with an existing molecule list, a straightforward contract manufacturer is usually sufficient.

  • What documents does a contract manufacturing partner provide for export?

    WHO-GMP Certificate covering the required dosage form, DCGI Manufacturing Licence for each molecule, COPP from CDSCO, Free Sale Certificate, COA per batch, ICH Zone IVb stability data, and a CTD/ACTD dossier for registration submission.

  • Can I use a contract manufacturer in India for my own branded label?

    Yes — contract manufacturing allows you to have pharmaceutical products manufactured under your own brand label by a WHO-GMP certified manufacturer. The manufacturer holds the manufacturing licence; you hold the import licence or marketing authorisation. Confirm COPP can be issued referencing your brand name specifically.

    British Pharmacopoeia 2024

  • How long does it take to get a COPP for a contract-manufactured product?

    A fresh COPP application typically takes 30–90 days. Manufacturers with prior export experience to a specific country typically hold active COPPs providable within 24–48 hours.

    WHO Technical Report Series No. 986, Annex 10

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.

Send an enquiry
Contract Manufacturing
WhatsApp

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

Looking for something specific?

At 9M India Limited, trust through quality, transparency, performance.

Get In Touch With Us

Contract Manufacturing

Contract Manufacturing

3rd Party Manufacturing

3rd Party Manufacturing

Institutional Tenders

Institutional Tenders

Generic Medicines

Generic Medicines

OTC Products

OTC Products

Regulatory Services

QC & QA