Caplin Steriles, a subsidiary of Caplin Point Laboratories, has received approval from Brazil's National Health Surveillance Agency ANVISA for its sterile injectable manufacturing site near Chennai, Tamilnadu.
The approval grants access to the company to register and market its products in Brazil, the largest Pharmaceutical market in Latin America.C. C. Paarthipan, chairman of Caplin Point Laboratories commented Brazil is an important target for Caplin Steriles' mid to long term expansion plans. As a first step, we will focus on extending our US approved products for Brazil.
The National Health Surveillance Agency or ANVISA (Agcia Nacional de Vigilcia Sanitia) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. The agency is connected to the Ministry of Health, which manages ANVISA through a management contract signed periodically.
Caplin Steriles is a niche sterile product manufacturing company that is approved by USFDA and EU-GMP. Caplin Steriles has developed and filed 20 ANDAs in USA on its own and with partners, with 16 approvals so far. The company is also working on a portfolio of around 45 simple and complex injectable and ophthalmic products, that it intends to file over the next 4 years.
Caplin Point Laboratories is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. On a consolidated basis, the company's net profit increased by nearly 30% to Rs 70.85 crore on a 25.1% rise in net sales to Rs 300.44 crore in Q1 FY22 over Q1 FY21.
Shares of Caplin Point were trading 1.73% lower at Rs 807.15 on BSE.
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