Caplin Steriles Gummidipoondi facility gets zero USFDA observations
Mumbai: Caplin Point Labs has announced that the United States Food and Drug Administration (US FDA) has concluded an unannounced inspection with zero observations at Caplin Steriles' injectable and ophthalmic manufacturing facility located at Gummidipoondi.
The inspection was conducted between August 5th and 9th, 2024.
"This is to inform you that the United States Food and Drug Administration (US FDA) conducted an unannounced inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The inspection was conducted between August 5th and 9th, 2024 and concluded with zero observations," the Company stated in a BSE filing.
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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: USFDA nod to Caplin Steriles Timolol Maleate Ophthalmic Solution
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