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 Injection USP, 15 mg/mL and 30 mg/mL Single-dose Vial, a generic therapeutic equivalent version of (RLD), TORADOL injection of Roche.
Ketorolac Tromethamine Injection USP is a nonsteroidal anti-inflammatory drug (NSAID), indicated for the short-term (≤5 days) management of moderately severe acute pain.
According to IQVIATM (IMS Health), Ketorolac Tromethamine Injection USP had US sales of approximately $53 million for the 12-month period ending December 2022.
About Caplin Steriles Limited
Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a niche sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP and ANVISA. Caplin Steriles Limited, has developed and filed 30 ANDAs in USA on its own and with partners, with 21 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.
About Caplin Point Laboratories Limited
Caplin Point Laboratories Limited is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. Caplin Point is one of the few companies to show consistent high-quality growth in Revenues, Profits and Cash flow over the last 15 years. The Company has state of the art manufacturing facilities that cater to a complete range of finished dosage forms. The Company has also entered regulated markets such as US, Canada, Australia etc through its Subsidiary Caplin Steriles Limited.
Be First to Comment