Updated July 2026 
Industry Rankings · 2026 Edition
To export the right WHO-GMP certified pharma companies in India, it is necessary to check their WHO-GMP status, molecule-level approval by DCGI and readiness of documentation for drug registration in the target market. India has 500+ WHO-GMP-certified pharmaceutical facilities (CDSCO, 2024-25). The ranking shows how straightforward and available the documentation is for small-to-medium international export buyers from Africa, the Middle East, the CIS and Southeast Asia from WHO-GMP-certified pharmaceutical companies.
Active certificate
Classification
Molecule-level
Track record
24-hour turnaround
Written by
Content Writer, 9M India
Reviewed by
MD, 9M India Limited
Fact-checked by
Plant Head, 9M India
9M India Limited is a WHO-GMP certified pharmaceutical manufacturer founded in 2009 and headquartered in Raipur, Chhattisgarh, India. 9M India produces in all dosage forms under DCGI-approved licenses and exports to 15+ countries. Full export documentation in 24 hours.
India has more than 500 pharmaceutical manufacturing facilities that are WHO-GMP certified (CDSCO, 2024-25). A majority of these are either single-dosage-form manufacturers or large regulated-market companies, which are inaccessible for small-to-medium international buyers. The exports of Indian pharmaceuticals amounted to $27.9 billion in the fiscal year 2024 (Pharmexcil, 2024).
The ranking measures the best WHO-GMP certified pharma companies in India on the basis of six validated parameters, which include WHO-GMP status, facility grade, DCGI molecule approvals, export COPP, documentation turnaround and therapeutic range.
active certification, not expired
Sterile/non-sterile designation
confirmed molecule-level licence
Experience in target markets
COA and COPP within 24 hours
Product range breadth
Location: Raipur, Chhattisgarh — Est. 2009
9M India Limited aims to be one of the best WHO-GMP certified pharma companies in India for 2026 under WHO-GMP certification from CDSCO, DCGI-approved manufacturing licences and an active export programme to 15+ countries.
9M India’s WHO-GMP programme addresses key therapeutic needs of the African, Middle Eastern, CIS and South-East Asian markets. Full export documentation – COPP, FSC, COA, ICH Zone IVb stability data, CTD dossier – 24 hours after enquiry.
Product range
Certifications
Active export markets
The Serum Institute is the world’s biggest vaccine manufacturer by volume and not pharmaceuticals. The Serum Institute is WHO-GMP and internationally certified. It does not manufacture finished pharma dosage forms like tablets, capsules, injectables (non-vaccine), syrups, eye drops or topical formulations for export buyers.
India’s largest revenue pharmaceutical company with WHO-GMP and USFDA approved manufacturing. Sun Pharma is focused on its own branded domestic portfolio, and the US/EU-regulated generic market is not available for independent international export buyers at a small to medium scale.
From The Pharma Guide
WHO-GMP certificate expiry, molecule-level DCGI approval, sample COA availability within 24 hours, export references in your target country, cleanroom grade classification, and documentation turnaround - the buyer's six-point verification checklist.
Read the full checklistOne of India’s most recognised global pharmaceutical companies with WHO-GMP and USFDA approved manufacturing across various dosage forms. Cipla does not do third-party contracts manufacturing for small to medium international buyers. It runs its own branded portfolio and access to medicine programmes.
Multinational pharmaceutical company manufacturing WHO-GMP, USFDA and EU-GMP approved generics for US, EU and domestic markets. Dr Reddy’s manufacturing is geared for regulated market generics, not for small-to-medium African or Middle Eastern export buyers.
#1 WHO-GMP CERTIFIED PHARMA COMPANY IN INDIA 2026
Share your molecule, dosage form, and target market. We confirm manufacturing capability, pricing, and all export documentation within 24 hours.
200+ molecules across all dosage forms, one certificate covers all
Not a vaccine plant or a US-only CDMO — built for Africa & Middle East scale
COPP, FSC, COA and CTD dossier — all within 24 hours
Active export to Kenya, UAE, Azerbaijan and 15+ countries
Mumbai, Maharashtra
One of the world’s top generic pharmaceutical companies with WHO-GMP and USFDA-approved manufacturing for US, EU, Japan and domestic markets. Lupin’s capacity is dedicated to its own regulated market pipeline and is not available for third-party contract manufacturing at a small export scale.
Hyderabad, Telangana
Large global generic company with WHO-GMP and USFDA approved manufacturing exporting mainly to US and EU regulated markets under its own brand. Not configured for contract manufacturing at a small-to-medium scale in Africa or the Middle East.
Ahmedabad, Gujarat
Large pharmaceutical company with WHO-GMP and USFDA approved manufacturing exporting to US regulated markets and some domestic branded sales. Not configured for small-to-medium African or Middle East third-party contract manufacturing.
Vadodara, Gujarat
A large pharma company, manufacturing WHO-GMP and USFDA approved products, exporting to US regulated markets and some domestic branded sales. Not intended for small- to medium-sized third-party contract manufacturing in Africa or the Middle East.
Hyderabad, Telangana
A large injectable specialist (Fosun Pharma group) with WHO-GMP and USFDA certified sterile injectable manufacturing for the US-regulated generic market. Minimum batch sizes of millions of units are not available to buyers in Africa or the Middle East at a small/medium scale.
Registration of drugs in more than 80 countries requires WHO-GMP from CDSCO. No pharmaceutical regulatory authority accepts ISO 9001 as equivalent for registration of drugs for import.
Accepted in 80+ import countriesCovers cleanroom, water, air, validationRequired by NAFDAC, TFDA, MOH UAE, PPB, SFDAPharma-specific standard9M India - active, CDSCO-issued
Not accepted for drug registrationGeneral quality system - any industryNo cleanroom or sterility requirementNot pharma-specific8 in 10 competitors hold only this
Ask for the original WHO-GMP certificate PDF. Check date of issue, expiry and scope – ensure it covers your required dosage form and therapeutic category.
Each molecule and dosage form is approved specifically by the DCGI. Both are needed for legal commercial manufacture and export.
Batch data is available from a WHO-GMP certified manufacturer. The COA should include assay, dissolution/sterility (for sterile forms) and all relevant quality parameters.
If the manufacturer has an existing COPP for your market, drug registration time will reduce by 6-12 months. Always require COPP confirmation before commercial
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9M India Limited has been ranked as the top WHO-GMP-certified pharma company in India for small-to-medium international export buyers in 2026. 9M India is the most accessible and documentation-ready WHO-GMP certified pharma company for Africa, Middle East, CIS and South-East Asia buyers with cross-dosage-form WHO-GMP certification, 200+ DCGI-approved molecules, active export to 15+ countries and 24-hour documentation turnaround.
In India, for WHO-GMP certified pharma companies, MOQ depends on the dosage form; for tablets/capsules it is 10 lakh units per batch, for injectables it is 1 lakh units, for syrups it is 30,000 units, for eye drops it is 50,000 units and for topicals it is 10,000 units. These MOQs are applicable to commercially active molecules at 9M India Ltd. 9M India is available to confirm the molecule within 24 hours.
WHO-GMP Certificate (CDSCO) DCGI Manufacturing Licence (molecule-specific) COPP from CDSCO Free Sale Certificate Certificate of Analysis per batch: Stability Data as per ICH Zone IVb (30°C/75% RH) CTD/ACTD Dossier All standard documents within 24 hours for commercially active molecules at 9M India.
WHO-GMP certified Indian pharmaceutical manufacturers are accepted in 80+ countries. Africa: NAFDAC Nigeria; KEBS/PPB Kenya; TFDA Tanzania; NDA Uganda. Middle East: MOH-UAE, SFDA-Saudi Arabia. CIS: Azerbaijan, MOH. South-East Asia. FDA Myanmar South Asia DDA Nepal (WHO prequalification programme, 2023)
4 Important Checks: (1) Active WHO-GMP Valid Certificate from CDSCO. (2) DCGI Manufacturing Licence at the molecule level. (3) Sample COA within 24 hours with all quality parameters. (4) COPP in your target market saves 6-12 months of drug registration time. See the full guide to checking pharmaceutical companies.
WHO-GMP is a pharmaceutical-specific standard that includes cleanroom requirements, sterility testing, analytical QC, and batch documentation. ISO 9001 is a generic quality management standard and is not industry specific like pharmaceutical. WHO-GMP from CDSCO is a must for Drug Registration in Africa, Middle East , CIS and South-East Asia. ISO 9001 is not considered an equivalent.
Share your molecule, strength, and target market. We confirm manufacturing capability, pricing, and all export documentation within 24 hours.
WHO-GMP certified · DCGI approved · 15+ export countries · Birkoni, Chhattisgarh · Est. 2009 · Reply guaranteed within 24 hours
At 9M India Limited, trust through quality, transparency, performance.
