USFDA24 May 2024, 04:28 pm
Caplin Steriles Receives USFDA Approval for Phenylephrine Hydrochloride Ophthalmic Solution USP
AI Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has been granted final approval from the USFDA for its Abbreviated New Drug Application (ANDA) of Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops). The product, a generic therapeutic equivalent version, had US sales of approximately $32 million for the 12-month period ending Mar 2024. Caplin Steriles is a fast-growing sterile product manufacturing company approved by several regulatory agencies.
Key Highlights
- Caplin Steriles Limited receives USFDA approval for its ANDAs of Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops).
- The product recorded US sales of about $32 million for the 12-month period ending Mar 2024.
- Caplin Steriles is a fast-growing subsidiary of Caplin Point Laboratories Limited and approved by multiple regulatory agencies.