India Pharma Outlook Team | Tuesday, 27 January 2026
Naprod Life Sciences has clinched a fresh ANVISA GMP renewal for its manufacturing facility in Tarapur, strengthening its foothold in one of the world’s toughest regulated markets.
The renewed Good Manufacturing Practice (GMP) certification of the plant was granted by Brazil National Health Surveillance Agency (ANVISA) on the basis of a comprehensive audit of the oncology injectable and oral solid dosage lines of the plant, on which no critical observations were made.
This inspection which was done in July 2025 as part of partner led regulatory requirements confirmed that the processes, quality systems and compliance measures of Naprod are of high international standards. With ANVISA GMP renewal, the company is now able to proceed with the production and exportation of key products to Brazil, which is a significant market in the Latin American pharma.
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This renewal helps us to serve our expansion objectives in Brazil, as we have a strong oncology and specialty business in Brazil, and it is also a strategic market, according to Mohan Jain, Managing Director of Naprod Life Sciences.
Tarapur is the liquid and lyophilis injectable formulation plant of Naprod in Maharashtra, which manufactures oral solid formulations in oncology among various other therapy sectors. The site is already certified with significant international qualifications i.e. EU-GMP, PIC/S and WHO-GMP and the ANVISA GMP renewal provides an additional level of assurance on global compliance.
This certification is likely to assist Naprod to match the growth in demand of specialty medicines in foreign regions. It also forms the basis of the company efforts of enhancing partnerships, building on its international customer base and ensuring consistent access to regulated markets that are pegged on high quality standards.