Chennai: Caplin Steriles Limited, a subsidiary 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) Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops).
The product is a generic therapeutic equivalent version of the Reference Listed Drug (RLD), from Alcon Research LLC.
Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% is indicated to dilate the pupil of the eyes.
According to IQVIA (IMS Health), Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% had US sales of approximately $32 million for the 12-month period ending Mar 2024.
team had earlier reported that Caplin Steriles had received nod from the USFDA for its Abbreviated New Drug Application (ANDA) Ofloxacin Ophthalmic Solution USP 0.3% (eye drops).
Read also: USFDA grants nod for Caplin Steriles Ofloxacin Ophthalmic Solution
Caplin Steriles 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 41 ANDAs in USA on its own and with partners, with 28 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: Caplin Steriles bags USFDA approval for Ketorolac tromethamine Ophthalmic Solution