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Updated July 2026

Pharma Guide · Buyer Checklist

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

With over 500 WHO-GMP certified pharmaceutical facilities in India (CDSCO, 2024-25), topical formulations face a specific risk most buyers underestimate: physical stability in tropical storage conditions. Six specific checks — including one most buyers never think to ask about — determine whether your cream or ointment survives the journey to a hot-climate export market intact.

  • 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 holds DCGI-approved manufacturing licences for topical formulations across 200+ molecules, including antifungal, corticosteroid, antibiotic, and combination creams and ointments. 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

Dermatological and topical formulations constitute a growing segment of India’s $27.9 billion pharmaceutical export total (Pharmexcil, 2024), driven substantially by antifungal topicals — Clotrimazole, Miconazole, Ketoconazole, Luliconazole — for tropical climate markets with high fungal infection burden. A verification challenge specific to topicals: creams and ointments are emulsions or semi-solid bases that can physically separate, change texture, or liquefy under heat stress in ways standard chemical assay data won’t catch — a risk most buyers don’t think to ask about explicitly. These six checks are the practical buyer’s verification framework, drawn from the documentation requirements of NAFDAC (Nigeria), MOH UAE, and WHO prequalification guidelines.

WHO-GMP Certification

Confirm WHO-GMP certificate scope explicitly covers topical dosage forms

Some facilities hold WHO-GMP for solid oral or sterile forms only — not topical manufacturing.

#1 of 6

WHO-GMP certifies the facility, but the certification scope is specific to the dosage forms inspected and approved. Ask for the certificate and check the scope line explicitly covers cream, ointment, and gel manufacturing before proceeding.

What is WHO-GMP certification in India?
WHO-GMP is issued by CDSCO following on-site inspection against World Health Organization Good Manufacturing Practice guidelines, and is time-limited, requiring periodic re-inspection. For topical products specifically, the inspection additionally validates semi-solid manufacturing equipment, homogenisation processes, and fill-finish for tubes and jars.

How to verify - step by step

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

  • Check the scope line explicitly: It should list cream, ointment, or gel manufacturing 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
NAFDAC and MOH UAE require the submitted WHO-GMP certificate to explicitly cover the dosage form being registered — a general facility certificate without topical scope will not satisfy this requirement.

Red flags to watch for

Certificate scope lists only oral solid dosage forms · Manufacturer assumes topical coverage without showing the scope line · Certificate older than 3 years without re-inspection documentation · Cannot provide certificate within 24 hours

From Industry Rankings

See how the top 10 ointment & cream manufacturers in India compare on stability data

Our editorial ranking compares the top 10 topical manufacturers in India across all 6 criteria in this guide — WHO-GMP scope, DCGI combination approvals, tropical stability data, PET testing, export track record, and documentation speed.

See the full ranking

DCGI Approval

Confirm DCGI approval at the molecule AND combination level

Combination topicals require a specific DCGI licence for the exact combination — not just individual molecule approvals.

#2 of 6

Combination topicals — such as Betamethasone+Clotrimazole or triple-combination antifungal creams — require a distinct DCGI licence for the exact combination and strength, not just individual molecule approvals held separately.

Why this trips up buyers most often for topicals
A manufacturer holding individual DCGI approvals for a steroid and an antifungal separately does not automatically hold approval to combine them into a single cream. Some combinations may also carry Schedule H prescription-only restrictions under the Drugs and Cosmetics Act — confirm this before ordering.

How to verify — step by step

  • Request the combination-specific DCGI licence: Not individual molecule approvals — the combination approval document itself.

  • Confirm the exact strength and ratio matches: Your specific formulation, not a similar but different combination.

  • Check Schedule H prescription-only status if applicable: This affects registration and distribution requirements in some markets.

  • Ask how long the combination approval has been active: Recently approved combinations may have thinner export/COPP history.

Why this check matters for export
Import regulators check the DCGI licence against the exact combination filed in the dossier — a mismatch between individually-approved molecules and an unapproved combination is a common cause of rejection.

Red flags to watch for

Manufacturer shows individual molecule approvals, not combination approval · Strength or ratio doesn’t match your exact formulation · No clarity on Schedule H status where relevant · No history of exporting this specific combination

Stability Data

Request ICH Zone IVb stability data — with physical stability specifically included

A cream that separates or an ointment that liquefies after months in a hot warehouse is a failed shipment.

#3 of 6

For tropical climate export, request stability data at 30°C/75% relative humidity that explicitly includes physical stability observations — phase separation, texture change, and liquefaction are common failure modes for creams and ointments that standard chemical stability data alone won’t catch.

Why physical stability matters more for topicals than other dosage forms
Creams and ointments are emulsions or semi-solid bases, structurally more vulnerable to heat and humidity stress than tablets or capsules. A product can pass chemical assay perfectly while visibly separating or changing texture on the shelf — request stability reports that document physical appearance and consistency at each time point, not just active ingredient content.

How to verify — step by step

  • Request Zone IVb-specific data: 30°C/75% RH — not just standard 25°C/60% RH conditions.

  • Confirm physical stability observations are explicitly included: Phase separation, texture, colour, and consistency at each interval — not just assay.

  • Check the shelf-life claim matches the data: A 24-month claim needs 24-month real-time data.

  • Ask for combination-specific stability data if applicable: Combination products may degrade differently than either molecule alone.

Why this check matters for export

Import regulators reviewing topical product dossiers specifically look for physical stability observations alongside chemical assay — an incomplete stability package is a common cause of registration query for this dosage category.

Red flags to watch for

Only chemical assay data offered without physical stability observations · Only 25°C/60% RH data offered when Zone IVb is required · Shelf-life claim exceeds available real-time stability data · No combination-specific stability data for combination products

From the Compare section

Cream vs ointment vs gel — which topical base fits your export market?

Ointments are anhydrous and highly occlusive, best for dry conditions. Creams are cosmetically elegant emulsions suited to most dermatological applications. Gels are quick-drying, preferred for hairy areas and NSAID analgesic topicals.

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

Preservative Efficacy

Request Preservative Efficacy Test (PET) data for multi-use packaging

A cream in a multi-use jar without validated preservative efficacy is a contamination risk waiting to happen.

#4 of 6

Creams and ointments in multi-use tubes or jars require validated preservative systems to prevent microbial contamination across repeated use over the product’s shelf life. Request Preservative Efficacy Test (PET) data per European Pharmacopoeia criteria as a standard part of the documentation package.

Why PET data absence signals an incomplete stability package
PET testing challenges the formulation with specific microorganisms and measures the preservative system’s ability to reduce contamination over defined time intervals. Its absence from a manufacturer’s standard documentation is a signal the stability package overall may be incomplete, not just this one test.

How to verify — step by step

  • Request PET data specifically: Per European Pharmacopoeia criterion A or B, as part of the standard documentation package.

  • Confirm the preservative system used: Parabens, phenoxyethanol, benzyl alcohol, or other validated systems.

  • Check PET data matches your exact packaging format: Tube vs jar can affect contamination risk and preservative requirements.

  • Ask about single-use/unit-dose alternatives if PET data is unavailable: Some markets may accept preservative-free single-use formats instead.

Why this check matters for export
Import regulators reviewing topical dossiers for multi-use packaging formats specifically expect PET data as part of the Quality module — its absence is treated as an incomplete submission.

Red Flags to Watch For

No PET data available for multi-use packaging formats · Preservative system not disclosed · PET data doesn’t match the actual packaging format being ordered · Manufacturer unfamiliar with European Pharmacopoeia PET criteria

Certificate of Analysis

Request a sample Certificate of Analysis within 24 hours — and know what to look for

A genuine topical manufacturer in India holds batch release data and can share a sample COA immediately.

#5 of 6

A Certificate of Analysis (COA) is the batch-level document proving a specific production batch meets all specifications. A legitimate topical manufacturer generates a COA for every batch — a sample should be available within 24 hours.

What a complete topical COA must contain
Beyond assay, topical COAs require physical characteristics (appearance, homogeneity), microbial limits, preservative content, and pH — parameters that determine both efficacy and patient tolerability of the finished cream or ointment.

How to verify — step by step

  • Request a real sample COA: From an actual recent batch, not a template.

  • Confirm physical characteristics are described, not just assay: Appearance and homogeneity assessment specifically.

  • Check preservative content is tested: Not just assumed present from the formulation.

  • Verify the signing authority: Should be signed by a Qualified Person or pharmacist.

Parameter Why It Matters
Assay (potency) Confirms active ingredient at label strength
Physical characteristics Confirms appearance, homogeneity, no visible separation
Microbial limits Confirms contamination within acceptable range
Preservative content Confirms preservative system is present at effective level
pH Confirms skin tolerability and formulation stability

Why this check matters for export
International regulators require actual numerical results — a COA showing only “Pass” without values, or missing physical characteristics, is treated as incomplete for dossier submission

Red Flags To Watch For

COA not available within 24 hours · Physical characteristics/homogeneity not described · COA is a blank template without real batch data · Preservative content not tested

Export References

Ask for export references and COPP for your specific target country

General export claims mean little if none of it covers products with similar climate exposure to yours.

#6 of 6

A Certificate of Pharmaceutical Product (COPP) confirms a specific product is authorised for manufacture and sale in India. Confirm the manufacturer’s export history covers topical products specifically to markets with similar climate conditions to yours — tropical climate export experience is a meaningfully stronger signal than general export claims.

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]?” — specifically, not general export history.

  • Ask “Do you hold an active COPP for [country]?” — confirm it covers your exact molecule and combination.

  • Ask about climate-related complaints or returns history: A manufacturer with genuine experience will speak candidly about how they’ve addressed this.

  • Request a CTD or ACTD dossier if available: Export-experienced manufacturers typically hold ready dossiers.

Why this check matters for export
A manufacturer with genuine tropical-climate topical export experience will have already resolved the physical stability challenges covered in Check 3 — this is a strong practical signal beyond the paperwork itself.

Red Flags To Watch For
General export claims without topical-specific references · No COPP covering your exact molecule or combination · No candid discussion of climate-stability challenges when asked · Cannot name a specific topical product previously registered

More Pharma Guide

Frequently asked questions

  • Why does physical stability matter more for topicals than other dosage forms?

    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 DCGI approvals are required for combination topical products?

    Combination formulations like antifungal+steroid creams require a specific DCGI licence for that exact combination and strength — separate from individual molecule approvals. Some combinations may also carry Schedule H prescription-only restrictions.

  • What is a Preservative Efficacy Test (PET) and why does it matter?

    PET testing challenges a formulation with specific microorganisms and measures the preservative system’s ability to reduce contamination over time, per European Pharmacopoeia criteria. It confirms multi-use packaging (tubes, jars) remains microbiologically safe across repeated use.

  • What should a topical Certificate of Analysis contain?

    A complete COA shows batch number, dates, assay, physical characteristics (appearance, homogeneity), microbial limits, preservative content, and pH — with actual numerical or descriptive results, not just pass/fail.

    British Pharmacopoeia 2024

  • What is the minimum order quantity for topical manufacturing in India?

    MOQ typically starts from 10,000 units per batch at WHO-GMP certified manufacturers for standard cream and ointment formulations. Pack size affects total batch weight — confirm molecule and pack-specific MOQ directly.

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

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