Naprod Life Sciences Secures ANVISA GMP Renewal for Tarapur Facility
Mumbai: Naprod Life Sciences Pvt. Ltd. has announced 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 evaluated Naprod’s oncology injectable and oral solid dosage operations. The inspection, carried out as part of ongoing partner-led regulatory requirements, involved a comprehensive assessment of the facility’s manufacturing processes, quality systems and compliance framework. The audit concluded with no critical observations, reinforcing Naprod’s adherence to global quality and regulatory standards.
The Tarapur facility is an integrated manufacturing site with dedicated oncology and general blocks, designed to produce liquid and lyophilised injectable formulations as well as solid oral dosage forms. The continued ANVISA GMP certification enables Naprod to manufacture and supply oncology and select general therapeutic products to Brazil, one of the largest pharmaceutical markets in Latin America.
Commenting on the development, Mohan Jain, Managing Director, Naprod Life Sciences Pvt. Ltd., said the renewal underscores the company’s commitment to regulatory excellence and quality manufacturing. He noted that Brazil remains a strategic market for Naprod and that the certification supports its objective of expanding its presence while supplying high-quality oncology and specialty products.
The continuous GMP certification also strengthens Naprod’s global regulatory standing, complementing its existing approvals, including EU-GMP, PIC/S and WHO-GMP. As Brazil is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the renewed approval is expected to facilitate access to other PIC/S-aligned markets across Latin America.
The certification supports Naprod’s broader growth strategy by enabling product commercialisation, expansion of its international customer base and advancement of partnerships in manufacturing, co-development and technology transfer, thereby improving speed-to-market in key regional markets.
Founded in 1994 and headquartered in Mumbai, Naprod Life Sciences Pvt. Ltd. is an Indian pharmaceutical company with a focus on oncology and anaesthesia therapies. The company manufactures formulations and specialty injectables for domestic and international markets, with a portfolio spanning oncology, cardiovascular, anaesthetic, anti-ulcerative and anti-infective segments. Naprod operates a manufacturing facility in Palghar, Maharashtra, accredited by EU-GMP, ANVISA (Brazil), INVIMA (Colombia), PIC/S and regulatory authorities across Africa and CIS markets.
