ANVISA-Brazil concludes inspection at Caplin Steriles Gummidipoondi facility with zero observations

Chennai: Caplin Point Laboratories Limited has informed that ANVISA-Brazil concluded an inspection at Caplin Steriles' injectable and ophthalmic Gummidipoondi manufacturing facility with zero observations.

The inspection was conducted between August 12th and 16th, 2024 

Chairman C.C.Paarthipan added, “It is indeed gratifying to have two back to back audits with Zero observations. We remain steadfast in our commitment to maintaining the highest levels of quality compliance at all our sites. Brazil is an important part of our expansion plans in Latin America and this clearance opens the door to the largest market in that geography.”

As per a Medical Dialogues report, the USFDA had also concluded an unannounced inspection with zero observations at Caplin Steriles' injectable and ophthalmic manufacturing facility located at Gummidipoondi.

Read also: Caplin Steriles Gummidipoondi facility gets zero USFDA observations

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited, has developed and filed 42 ANDAs in USA on its own and with partners, with 30 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Mexico, Australia, Canada, South Africa etc

Read also: Caplin Steriles bags USFDA nod for Phenylephrine hydrochloride Ophthalmic Solution