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Caplin Point Laboratories said its wholly owned subsidiary, Caplin Steriles, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Verapamil Hydrochloride injection USP, 5 mg/2 mL (2.5 mg/mL) and 10 mg/4 mL (2.5 mg/mL) single-dose vial, a generic therapeutic equivalent version of (RLD), Isoptin injection, 2.5 mg/mL, of Mt. Adams Technologies LLC.
Verapamil Hydrochloride is a calcium channel blocker used in the treatment of cardiac conditions such as high blood pressure, arrhythmias and angina. According to IQVIA (IMS Health), Verapamil Hydrochloride injection USP had US sales data of approximately $28 million for the 12-month period ending December 2019.
Caplin Steriles has developed and filed 15 ANDAs on its own and with partners, with 7 approvals so far. The company is also working on a portfolio of 35 simple and complex Injectable and Ophthalmic products, to be filed over the next 4 years.
Shares of Caplin Point extended gains for the second day. In the past two sessions, the stocks has added 17.16% from a recent closing low of Rs 193.75 recorded on 24 March 2020.
Caplin Point Laboratories is a fast-growing pharmaceutical company with a business model catering predominantly to emerging markets of Latin America and Africa. The company has manufacturing facilities that cater to a complete range of finished dosage forms. The company's wholly owned subsidiary Caplin Steriles caters to the regulated markets for injectable and ophthalmic products.
The pharmaceutical company reported 27.8% rise in consolidated net profit to Rs 58.56 crore on a 43.5% jump in net sales to Rs 228.21 crore in Q3 December 2019 over Q3 December 2018.
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