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

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