Jan 2026 ANVISA GMP renewed for Tarapur facility Read more
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Quality & Regulatory

One sterile-injectables site, audited by 21 authorities across six regions.

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.

21 international accreditations · 6 verified against official regulator lists · manufacturing since 1994

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Accreditation register

21 accreditations, one manufacturing site

Naprod's Tarapur facility holds 21 international manufacturing accreditations. Three are fully published on this register today — ANVISA (Brazil), WHO-GMP, and ISO 9001:2015 — with issuing body, scope, and site (validity dates shown where a renewal has been published). The remaining 18 are confirmed on the company's official accreditation list and are being digitized for publication with the same level of detail: issuing body, certificate scope, and current validity.

21 accreditations on record · 3 detailed today · 18 being digitized

Pending approval 18 of 21 accreditations are being digitized for publication — issuing body confirmed, full scope and validity dates pending upload.

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. EU-GMP opens the European Union export market. ANVISA opens Brazil and, by extension, Mercosur trade. INVIMA opens Colombia and the Andean region. WHO-GMP supports WHO-regulated tenders, UN agencies, the Global Fund, and rest-of-world export markets that require it. UAE MOHAP and NHRA Bahrain open Gulf 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

ANVISA (Brazil), WHO-GMP, and ISO 9001:2015

ANVISA — Brazil's Agência Nacional de Vigilância Sanitária — renewed GMP certification for the Tarapur site in January 2026, extending it through January 2028 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. ISO 9001:2015 certifies the site's quality management system across pharmaceutical manufacturing operations. Full scope statements and certificate documents for all three are published on this page as they are 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, 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.