How to Source Finished Medicines from WHO-GMP Certified Manufacturers in India
Akuma Enterprises is a pharmaceutical trading and export company in Kharar, Punjab, India — not a manufacturer. We source finished medicines from WHO-GMP certified contract manufacturers in India and verify source licences and certificates before quoting.
Summary:In India, a WHO-GMP certificate (under the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce) is issued to a specific manufacturing site by the State Licensing Authority (State FDA), typically following joint inspection with CDSCO. Importers should always verify the certificate holder's name, site address, approved dosage categories, underlying Form 25/Form 28 manufacturing licence numbers, and expiry date.
1. What a WHO-GMP Certificate Covers (and What It Does Not)
A WHO-GMP certificate confirms that an audited manufacturing premises meets World Health Organization Good Manufacturing Practices for specific dosage lines listed on the certificate. It belongs solely to the licensed manufacturer and is valid only for the named site and dosage categories during its validity period.
Issuing framework in India: Issued under the Drugs and Cosmetics Act, 1940 and Rules by the State Drug Licensing Authority / State FDA following joint inspection with CDSCO Zonal Officers where applicable.
Key items to verify: Certificate number and file reference, full factory address, underlying manufacturing licences (e.g. Form 25 and Form 28), specific dosage categories authorized (beta-lactam vs. general lines), issue date, and validity expiry date.
Exporter vs. manufacturer role: Trading and export companies such as Akuma Enterprises hold GST and Import-Export Code (IEC) registrations, while WHO-GMP certificates and product permissions remain in the partner manufacturer's name.
Un certificat OMS-BPF atteste qu'un site de fabrication inspecté respecte les Bonnes Pratiques de Fabrication de l'Organisation mondiale de la Santé pour les lignes galéniques mentionnées sur le document. Il appartient exclusivement au fabricant agréé pour le site et la durée indiqués.
Autorité émettrice en Inde : Délivré en vertu du Drugs and Cosmetics Act 1940 par l'autorité pharmaceutique de l'État (State FDA), généralement après inspection conjointe avec les inspecteurs de la CDSCO.
Points de contrôle essentiels : Numéro de certificat et référence de dossier, adresse exacte de l'usine, licences de fabrication (Form 25 / Form 28), formes galéniques couvertes (lignes générales vs bêta-lactamines) et date d'expiration.
Rôle de l'exportateur et du fabricant : Une société de sourcing et d'export telle qu'Akuma Enterprises détient son enregistrement GST et son code import-export (IEC), tandis que le certificat OMS-BPF et l'autorisation de fabrication restent au nom du fabricant partenaire.
2. How Akuma Enterprises Qualifies Partner Manufacturers
Before quoting a finished medicine, Akuma Enterprises verifies documentation held by the partner manufacturer and shares copies with licensed trade buyers for their own supplier qualification:
Verified WHO-GMP & Form 25 / 28 Licences: For example, partner manufacturer M/s Agron Remedies Pvt. Ltd. (Sarverkhera, Moradabad Road, Kashipur-244713, U.S. Nagar, Uttarakhand, India) holds WHO-GMP Certificate No. 17P/1/30/2001 (valid until 01-08-2027, following joint inspection with CDSCO North Zone on 25-09-2024; view WHO-GMP PDF).
Additional Regulatory Audit Records: Partner manufacturer M/s Agron Remedies Pvt. Ltd. also holds NAFDAC Nigeria GMP approval Ref. NAFDAC/DER/HQ/006/VOL.IX/675 (valid through September 2028 covering Beta-Lactam Cephalosporins and General lines; view NAFDAC PDF).
Per-Shipment Documentation: Every dispatched batch includes the partner manufacturer's batch Certificate of Analysis (CoA). CoPP, Free Sale Certificate (FSC), stability summaries, and dossiers are requested per SKU from the manufacturer depending on availability.
Avant tout devis pour un médicament fini, Akuma Enterprises vérifie les documents détenus par le fabricant partenaire et transmet des copies aux importateurs agréés pour leur propre qualification :
Certificat OMS-BPF et licences Form 25 / 28 vérifiés : Par exemple, notre fabricant partenaire M/s Agron Remedies Pvt. Ltd. (Sarverkhera, Moradabad Road, Kashipur-244713, U.S. Nagar, Uttarakhand, Inde) est titulaire du certificat OMS-BPF n° 17P/1/30/2001 (valide jusqu'au 01-08-2027, suite à l'inspection conjointe CDSCO Zone Nord du 25-09-2024 ; consulter le PDF OMS-BPF).
Approbation d'inspection étrangère : M/s Agron Remedies Pvt. Ltd. détient également l'approbation GMP de la NAFDAC Nigeria réf. NAFDAC/DER/HQ/006/VOL.IX/675 (valide jusqu'en septembre 2028 pour les lignes Bêta-lactamines Céphalosporines et Générales ; consulter le PDF NAFDAC).
Documents de lot : Chaque lot expédié est accompagné du certificat d'analyse (CoA) du fabricant. Le CoPP, le Certificat de Libre Vente (CLV), les données de stabilité et les dossiers sont vérifiés auprès du fabricant selon le produit.
Frequently Asked Questions
Does Akuma Enterprises manufacture medicines or own a plant?
No. Akuma Enterprises is a pharmaceutical trading and export partnership firm in Kharar, Punjab, India (GSTIN 03ACLFA6940J1ZB, IEC ACLFA6940J). Finished medicines are manufactured by licensed WHO-GMP certified partner manufacturers in India.
In whose name are the WHO-GMP certificate, CoPP, and batch CoA issued?
They are issued in the name of the partner manufacturer that produces and releases the product (for example, M/s Agron Remedies Pvt. Ltd. for covered dosage lines). Akuma Enterprises obtains, verifies, and forwards these documents to licensed buyers.
Can an importer verify the partner manufacturer's WHO-GMP certificate before ordering?
Yes. Copies of verified partner certificates, including certificate numbers, approved dosage forms, site address, and validity dates, are provided on request and downloadable directly from our Certifications page for listed verified partners.
Request a quote or product documents
Contact us for a quote and the manufacturer's documents for your product.