Caplin Steriles Limited Receives USFDA Approval for Ketorolac Tromethamine Ophthalmic Solution 0.5%

Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Ketorolac tromethamine Ophthalmic Solution 0.5%. This solution is a generic equivalent of ACULAR Ophthalmic Solution of Allergan Inc., indicated for inflammation following cataract surgery and temporary relief of ocular itching due to seasonal allergic conjunctivitis. According to IQVIA™, sales of Ketorolac tromethamine Ophthalmic Solution 0.5% in the US were approximately $36 million for the 12-month period ending December 2023. Caplin Steriles Limited is a sterile product manufacturing company approved by numerous regulatory agencies and has filed 39 ANDAs in the US, with 26 approvals. The company is also working on a portfolio of over 40 simple and complex injectable and ophthalmic products for approval in the next 4 years. Caplin Point Laboratories Limited, the parent company, is a fast-growing pharmaceutical company with a unique business model catering to emerging markets in Latin America and Africa. It has consistently shown high growth in cashflows, profitability, and revenues for the past 15 years and has been recognized with various awards.