USFDA grants nod for Caplin Steriles Ofloxacin Ophthalmic Solution

Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ofloxacin Ophthalmic Solution USP 0.3% (eye drops).

The product is a generic therapeutic equivalent version of (RLD), OCUFLOX Ophthalmic Solution of Allergan Inc.

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers. Conjunctivitis, commonly known as "pink eye," is an inflammation or infection of the conjunctiva — the transparent membrane that covers the white part of the eye and lines the inside of the eyelids.

According to IQVIA (IMS Health), Ofloxacin Ophthalmic Solution USP 0.3% had US sales of approximately $52 million for the 12- month period ending December 2023.

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Medical Dialogues had earlier reported that Caplin Steriles Limited had been granted final approval by the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ketorolac tromethamine Ophthalmic Solution 0.5% (eye drops).

Read also: Caplin Steriles bags USFDA approval for Ketorolac tromethamine Ophthalmic Solution

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 and ANVISA. Caplin Steriles Limited, has developed and filed 41 ANDAs in USA on its own and with partners, with 27 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.