Caplin Steriles bags USFDA approval for Ketorolac tromethamine 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) Ketorolac tromethamine Ophthalmic Solution 0.5% (eye drops).

The product is a generic therapeutic equivalent version of (RLD), ACULAR Ophthalmic Solution 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.

Seasonal allergic conjunctivitis is an allergic reaction that affects the eyes, triggered by airborne allergens such as pollen, mold spores, and pet dander during specific seasons.

According to IQVIA (IMS Health), Ketorolac tromethamine Ophthalmic Solution 0.5% had US sales of approximately $36 million for the 12-month period ending December 2023.

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Caplin Point Laboratories Limited is a pharmaceutical company with a end to end business model catering predominantly to emerging markets of Latin America and Africa. The Company has state of the art manufacturing facilities that cater to a complete range of finished dosage forms.

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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, 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.

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