Naprod Life Sciences renews ANVISA GMP certification for Tarapur manufacturing facility
Renewal strengthens Naprod's ongoing access to Brazil and Latin American regulated markets for oncology and specialty formulations
Naprod Life Sciences is pleased to announce the continuous renewal of Good Manufacturing Practice (GMP) certification for its Tarapur manufacturing facility by ANVISA, Brazil’s National Health Surveillance Agency.
The renewal follows a successful regulatory inspection conducted in July 2025, which assessed Naprod’s oncology injectable and oral solid dosage operations. This inspection, part of ongoing partner-led regulatory requirements, involved a thorough evaluation of the facility, manufacturing processes, quality systems, and compliance practices. The audit concluded with no critical observations, further cementing Naprod’s commitment to maintaining world-class quality standards across its operations.
The Tarapur facility, an integrated manufacturing site, houses dedicated oncology and general blocks, designed to manufacture liquid and lyophilised injectable formulations as well as solid oral dosage forms. The continuous renewal of the ANVISA GMP certification ensures Naprod’s eligibility to manufacture and supply oncology and select general therapeutic products to Brazil, a key market in Latin America. Brazil represents the largest pharmaceutical market in the region, and this renewal allows Naprod to further strengthen its foothold in Brazil while meeting the regulatory standards required for pharmaceutical distribution.
Mohan Jain, Managing Director of Naprod Life Sciences remarked, “We are proud to continue our strong partnership with ANVISA, reaffirming our commitment to global regulatory excellence. The renewal of our GMP certification is a testament to the high-quality systems, processes, and teams we have in place. Brazil is a strategic market for us, and this renewal supports our goal of expanding our presence while delivering high-quality oncology and specialty products to our partners and patients.”
This continuous GMP certification also bolsters Naprod’s global regulatory portfolio, complementing existing approvals such as EU-GMP, PIC/S, and WHO-GMP. As Brazil is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the renewed approval further facilitates access to other PIC/S-aligned markets in Latin America. The certification continues to support Naprod’s growth strategy, enabling the commercialisation of developed products, expansion of its international client base, and advancement of partnerships in manufacturing, co-development, and technology transfer, thereby improving speed-to-market in key regional markets.