USFDA approves Caplin Steriles eye drop
Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by the United States Food and Drug Administration (USFDA)) for its Abbreviated New Drug Application (ANDA) Difluprednate Ophthalmic Emulsion, 0.05% (Eye drops).
The product is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DUREZOL, from Sandoz Inc.
Medical Dialogues team had earlier reported that the USFDA had approved Caplin Steriles's Abbreviated New Drug Application (ANDA) Timolol Maleate Ophthalmic Solution USP, 0.5% (Eye drops).
Read also: ANVISA-Brazil concludes inspection at Caplin Steriles Gummidipoondi facility with zero 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: USFDA nod to Caplin Steriles Timolol Maleate Ophthalmic Solution
