USFDA issues EIR for Caplin Steriles Gummidipoondi facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-01-07 06:00 GMT | Update On 2025-01-07 06:00 GMT
Chennai: Caplin Point Laboratories Ltd. has announced that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for the recent inspection conducted at Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi.
The unannounced USFDA inspection was conducted between August 5th and 9th, 2024 and was concluded with Zero 483 observations.
"The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements," the Company stated.
Medical Dialogues team had earlier reported that the USFDA had concluded an unannounced inspection with zero observations at Caplin Steriles' injectable and ophthalmic manufacturing facility located at Gummidipoondi.
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 45 ANDAs in USA on its own and with partners, with 31 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.
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