USFDA nod to Caplin Steriles Timolol Maleate Ophthalmic Solution

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) Timolol Maleate Ophthalmic Solution USP, 0.5% (Eye drops).

It is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) TIMOPTIC, from Bausch and Lomb Inc.

Timolol Maleate Ophthalmic Solution USP, 0.5% (Eye drops) is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma.

According to IQVIA (IMS Health), Timolol Maleate Ophthalmic Solution USP, 0.5% had US sales of approximately $45 million for the 12-month period ending June 2024.

Medical Dialogues team had earlier reported that the Company had received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops).

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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

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