Caplin Steriles Limited (Caplin), a subsidiary company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) ketorolac tromethamine ophthalmic solution 0.5% (eye drops), a generic therapeutic equivalent version of (RLD), ACULAR ophthalmic wolution of Allergan Inc.
Ketorolac tromethamine ophthalmic solution 0.5% is a nonsteroidal, anti- inflammatory indicated for the treatment of inflammation following cataract surgery and for the temporary relief of ocular itching due to seasonal allergic conjunctivitis.
According to IQVIATM (IMS Health), ketorolac tromethamine ophthalmic solution 0.5% had U.S. sales of approximately $36 million for the 12-month period ending December 2023.
About Caplin Steriles Limited Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a fast-growing sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, INVIMA and ANVISA. Caplin Steriles Limited, has developed and filed 39 ANDAs in USA on its own and with partners, with 26 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.