Caplin Point Laboratories said that its subsidiary — Caplin Steriles has secured approval from Agência Nacional de Vigilância Sanitária (ANVISA), the Brazilian national health surveillance agency, for its sterile injectable manufacturing plant in Tamil Nadu (TN).
The approval from ANVISA enables Caplin Steriles to register and market its products in Brazil, which is considered to be the largest pharma market in Latin America.
CC Paarthipan — Chairman of Caplin Point Laboratories said: “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.”
Caplin Steriles’ sterile injectable manufacturing site is located near Chennai. The sterile product manufacturing company has developed and filed 20 abbreviated new drug applications (ANDAs) in the US on its own and with partners, and so far, has 16 approvals.
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