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Jan 2026 ANVISA GMP renewed for Tarapur facility Read more

Quality & Regulatory

One sterile-injectables site, 15+ international accreditations.

Every accreditation on this register is issued and renewed independently by its own regulator, against Naprod's manufacturing facility at MIDC Tarapur, Boisar, Maharashtra, not against any single product.

15+ international accreditations · manufacturing since 1994

View the accreditation register Report a product complaint

Accreditation register

15+ accreditations, one manufacturing site

Naprod's Tarapur facility holds 15+ international manufacturing accreditations. Each register entry shows issuing body, scope, site, and validity where the issued certificate on file states it; entries still being digitized are labeled accordingly until their full detail is published.

21 accreditations on record · 15 detailed today · 6 being digitized

Group company

MacChem: API manufacturing accreditations

MacChem (MAC-CHEM PRODUCTS (INDIA) PVT. LTD.), the group's active-pharmaceutical-ingredient company, manufactures oncology and general APIs and sterile bulk from its own site at MIDC Tarapur, Boisar. It is a separate legal entity from Naprod, with its own accreditation register. These credentials support MacChem's API supply into the EU and WHO-regulated markets.

6 accreditations on record · all confirmed from certificates on file

Market access

Each accreditation is a key to a specific market

Regulatory affairs teams read this register as a market-access map, not a trophy wall. The accreditations group into three tracks: stringent regulatory authority (SRA) export, rest-of-world export, and domestic supply.

Each certificate is scoped to the Tarapur site's quality systems and process controls. It does not itself constitute approval of any individual product, and every underlying product registration still depends on its own dossier being filed and maintained in that market.

Currently detailed

Confirmed from certificates on file

ANVISA, Brazil's Agência Nacional de Vigilância Sanitária, renewed GMP certification for the Tarapur site in January 2026, with the certificate valid through June 2027 and covering sterile oncology injectables manufacturing. The renewal was reported by Pharma India Magazine. WHO-GMP certification, issued under the World Health Organization's GMP Certification Scheme, covers sterile and non-sterile pharmaceutical manufacturing at Tarapur and underpins Naprod's participation in WHO-regulated tenders and rest-of-world export. EU-GMP certification, issued by a European Union GMP competent authority, opens the European Union export market for the Tarapur site's sterile injectables. These three are among the accreditations confirmed from the issued certificate held on file, each carrying issuing body, scope, site, and validity detail; full documentation for further entries is published on this page as it is finalized.

Pharmacovigilance

Product complaints and safety reports

Distributors, regulatory affairs contacts, and healthcare professionals can report a product quality complaint or a suspected adverse event connected to a Naprod- or MacChem-manufactured product through the pharmacovigilance and product-complaint pathway maintained on the Contact page. Every report is logged and triaged, and, where it concerns a marketed product, routed to the responsible regulatory affairs contact for the market in question. Naprod does not make, and this page does not imply, any claim about the safety or efficacy of a marketed product; certification and complaint-handling statements here describe manufacturing quality systems and process controls only.

Pending approval Named quality-management-system framework and pharmacovigilance SOP references are pending company confirmation and are not published here until verified.