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Updated July 2026

Pharma Guide · Buyer Checklist

6 Things to Check Before Choosing a Tablet Manufacturer in India

With over 500 WHO-GMP certified pharmaceutical facilities in India (CDSCO, 2024-25), choosing the right injection manufacturer in India is not just about price. Six specific checks determine whether your supply chain will pass international drug registration — or fail at the regulator’s desk.

  • 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 200+ molecules across plain, film-coated, enteric-coated (EC), and fixed-dose combination (FDC) tablets. 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 produces over 150 billion tablet units annually (Pharmexcil export data estimate, 2024), driven substantially by plain, enteric-coated, and FDC tablets exported to Africa, Middle East, and South-East Asia. A verification challenge specific to tablets: DCGI approval is granted per dosage-form variant, so a manufacturer approved for plain tablets of a molecule may not hold separate approval for the enteric-coated or FDC version of the same drug. These six checks are the practical buyer’s verification framework, drawn from the documentation requirements of NAFDAC (Nigeria), KEBS/PPB (Kenya), MOH UAE, SFDA (Saudi Arabia), and WHO prequalification guidelines.

WHO-GMP Certification

Verify the WHO-GMP certificate expiry date — not just the existence of a certificate

The most common buyer mistake is confirming a WHO-GMP certificate exists without checking whether it's currently valid.

#1 of 6

When sourcing from a tablet manufacturer in India, request the actual WHO-GMP certificate document. It must show the facility name, manufacturing site address, licence number, dosage forms covered, issue date, and expiry date. WHO-GMP certificates in India are issued by CDSCO following an on-site inspection.

What is WHO-GMP certification in India?

WHO-GMP is a pharmaceutical-specific manufacturing standard covering facility design, water systems, air handling, process validation, analytical QC, and batch documentation. It is time-limited and requires 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 document: Ask for a PDF or scan on official CDSCO letterhead.

  • Check the expiry date explicitly: Do not accept a certificate without a visible expiry date.

  • Confirm dosage forms covered: The certificate should list solid oral dosage manufacturing.

  • Cross-verify on CDSCO database: Cross-reference at cdsco.gov.in using the licence number.

Why this check matters for export
NAFDAC, KEBS/PPB, MOH UAE, and SFDA all require submission of a valid, unexpired WHO-GMP certificate for drug registration. An expired certificate is grounds for automatic rejection. (WHO Technical Report Series No. 986, 2014)

Red flags to watch for

Certificate older than 3 years with no re-inspection documentation · Certificate does not list tablet/solid oral dosage forms · Manufacturer cannot provide certificate within 24 hours · Certificate shows a different manufacturing site

From Industry Rankings

See how the top 10 tablet manufacturers in India compare on WHO-GMP status

Our editorial ranking compares the top 10 tablet manufacturers in India across all 6 criteria in this guide — WHO-GMP status, dosage-form range, DCGI approvals, export track record, documentation speed, and FDC capability.

See the full ranking

DCGI Approval

Confirm DCGI approval at the molecule AND dosage-form level — the check most buyers miss

Plain-tablet approval does not automatically extend to the enteric-coated or FDC version of the same molecule.

#2 of 6

The WHO-GMP certificate covers the facility as a whole. The DCGI manufacturing licence is product-specific — specifying molecule, strength, and dosage-form variant. A manufacturer may hold DCGI approval for plain tablets of a molecule but not for its EC, sustained-release, or FDC version.

Why this distinction matters for tablets specifically

Tablets carry more dosage-form variants than almost any other category — plain, film-coated, enteric-coated, sustained-release, dispersible, chewable, and FDC. Each requires separate DCGI approval. Confirm the licence references your exact tablet type, not just the molecule name.

How to verify — step by step

  • Request the manufacturing licence: Ask for the DCGI licence referencing your exact molecule, strength, and tablet type.

  • Check dosage-form specificity: Confirm EC, SR, or FDC status is explicitly listed, not just the base molecule.

  • Verify FDC combination approval separately: If your product is a combination, confirm the exact ratio is approved — see Check 4.

  • Cross-check against Section 26A restrictions: Some FDC combinations are restricted; confirm yours is not.

Why this check matters for export
Import regulators require the dossier to cite a valid, dosage-form-specific manufacturing licence. A generic “tablet” approval that doesn’t specify EC or FDC status is a common cause of query and delay.

Red flags to watch for

Manufacturer presents facility WHO-GMP when asked for dosage-form approval · DCGI licence doesn’t specify EC/SR/FDC status · Manufacturer offers to “add” your dosage-form variant after the order is placed · Licence shows a different manufacturing site

Dissolution Data

Request dissolution profile data for EC and modified-release tablets

A tablet that dissolves too early — or too late — is a clinical failure, not a manufacturing inconvenience.

#3 of 6

For enteric-coated tablets, dissolution data must show less than 10% release at pH 1.2 within 2 hours (protecting the drug from stomach acid) and more than 80% release at pH 6.8 within 45 minutes (ensuring intestinal absorption). Modified-release tablets require a full dissolution profile across multiple time points.

Why dissolution data is non-negotiable for these tablet types
A manufacturer without documented dissolution data for stability batches — not just release batches — is not genuinely production-ready for that tablet type. Dissolution behaviour can drift over shelf life, which is why stability-batch dissolution data matters as much as day-one release data.

How to verify — step by step

  • Request the full dissolution profile: Not just a single time-point result — ask for the complete profile across the specification.

  • Confirm data is from stability batches: Not just from the original release batch.

  • Check pH conditions match tablet type: EC tablets need the two-stage pH test specifically.

  • Ask for dispersible tablet dispersion time: If applicable — WHO standard is under 3 minutes.

Tablet Type Key Dissolution Requirement
Enteric-coated (EC) <10% release pH 1.2 (2hrs); >80% release pH 6.8 (45min)
Sustained/Extended-release Multi-point profile across full dosing interval
Dispersible Complete dispersion within 3 minutes (WHO standard)

Why this check matters for export

Dissolution data is a standard, mandatory component of the Quality module (Module 3) in any CTD/ACTD dossier — its absence stalls submission at the outset.

Red flags to watch for

Only single time-point dissolution data offered · No stability-batch dissolution data available · EC tablet tested only at one pH condition · Dispersion time exceeds WHO standard for dispersible tablets

From the Compare section

Tablet vs capsule manufacturing — which dosage form fits your product?

Tablets offer longer shelf life and lower unit cost; capsules offer better bioavailability for some molecules and Halal compliance in HPMC form. The right choice depends on your specific molecule and target market.

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

FDC Approval

Confirm FDC-specific DCGI approval — where your product is a combination

Two individually approved molecules do not equal one approved combination.

#4 of 6

Fixed-dose combination (FDC) tablets require a distinct DCGI licence for the exact combination and ratio — separate from individual molecule approvals. Some combinations are restricted under Section 26A of the Drugs and Cosmetics Act, 1940.

Why FDC approval trips up buyers most often

A manufacturer holding individual DCGI approvals for both Molecule A and Molecule B does not automatically hold approval to combine them into a single FDC tablet. This is the single most common documentation gap buyers discover after formulation is already finalised — verify it before, not after.

How to verify — step by step

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

  • Confirm the exact ratio matches: E.g. Amlodipine 5mg + Atenolol 50mg is a different approval from Amlodipine 5mg + Atenolol 25mg.

  • Check Section 26A restricted list: Confirm your combination isn’t among restricted FDCs.

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

Why this check matters for export

Import regulators specifically check whether the manufacturing licence covers the combination as filed — a mismatch between individually-approved molecules and an unapproved combination is grounds for dossier rejection.

Red Flags to Watch For
Manufacturer shows individual molecule approvals, not combination approval · Ratio on the licence doesn’t match your exact formulation · Combination appears on Section 26A restricted list · No clarity on how long the FDC approval has been active

Certificate of Analysis

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

A genuine tablet 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 tablet manufacturer generates a COA for every batch as part of WHO-GMP batch release — a sample should be available within 24 hours.

What a complete tablet COA must contain
Beyond assay, tablet COAs specifically require hardness, friability, and uniformity of weight data — parameters that determine whether the tablet survives packaging and transport without crumbling or chipping.

How to verify — step by step

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

  • Check for hardness and friability specifically: These are the parameters most often omitted.

  • Confirm numerical values, not just pass/fail: Every parameter should show the actual result obtained.

  • 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
Dissolution Confirms release rate — see Check 3
Hardness Confirms tablet withstands handling without breaking
Friability Confirms resistance to chipping/abrasion during transport
Uniformity of weight Confirms consistent dosing across the batch
Microbial limits Confirms contamination within acceptable range

Why this check matters for export
International regulators require actual numerical results, not just pass/fail — a COA lacking hardness or friability data is treated as incomplete for dossier submission.

Red flags

COA not available within 24 hours · COA is a blank template · Hardness/friability data missing · COA shows only pass/fail without values

Export References

Ask for export references in your specific target country — an existing COPP saves 6–12 months

If the tablet manufacturer has already registered products in your market, your registration timeline shrinks dramatically.

#6 of 6

A Certificate of Pharmaceutical Product (COPP) confirms a specific product is authorised for manufacture and sale in India. If a tablet manufacturer has already exported to your target country and holds an active COPP, your registration timeline can shorten by 6–12 months.

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 tablets specifically, confirm the COPP references your exact dosage-form variant — a COPP for plain tablets doesn’t automatically cover an FDC or EC version. (WHO Technical Report Series No. 986, Annex 10)

How to verify — step by step

  • Ask “Have you previously exported to [country]?”: request the specific product name and year of first registration.

  • Ask “Do you hold an active COPP for [country]?”: confirm it matches your exact molecule and dosage-form variant.

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

  • Confirm FDC-specific COPP if applicable: A plain-tablet COPP doesn’t cover your FDC combination.

Why this check matters for export
Dossier review queues in Africa and the Middle East are long; an existing, dosage-form-matched COPP eliminates the initial 30–90 day waiting period entirely.

Red Flags to Watch For
Vague answers about prior export experience · COPP offered doesn’t match your specific dosage-form variant · No CTD/ACTD dossier despite claimed export history · Cannot name a specific country or product previously registered

More Pharma Guide

Frequently asked questions

  • How do I verify a WHO-GMP certificate for an Indian tablet manufacturer?

    Request the actual certificate on CDSCO letterhead showing facility name, site address, licence number, dosage forms covered, issue date, and expiry date. Cross-reference at cdsco.gov.in.

    Reference: Central Drugs Standard Control Organisation (CDSCO)

  • What is the difference between plain, EC, and FDC tablet DCGI approvals?

    DCGI approval is dosage-form specific. Plain tablet approval for a molecule does not extend to its enteric-coated or FDC version — each requires a separate DCGI manufacturing licence referencing the exact dosage-form variant.

  • What should a tablet Certificate of Analysis contain?

    A complete COA shows batch number, dates, assay, dissolution, hardness, friability, uniformity of weight, microbial limits, and the signature of the releasing Qualified Person — with actual numerical results, not just pass/fail.

    British Pharmacopoeia 2024

  • How long does it take to get a COPP for a tablet product from India?

    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

  • What is a restricted FDC combination under Section 26A?

    Section 26A of the Drugs and Cosmetics Act, 1940 allows the Indian government to prohibit manufacture and sale of certain fixed-dose combinations found to lack therapeutic justification. Always confirm your specific combination is not on the restricted list before ordering.

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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