CHENNAI / MUMBAI / RAJKOT - In a regulatory filing as submitted to the Indian Stock Exchanges, Chennai headquartered pharmaceutical products manufacturing Indian company Caplin Laboratories Ltd said of having got a nod from USFDA (US Food & Drugs Administration) to market to treat hypotension (abnormally low blood pressure).
In a press-release titled, "CAPLIN STERILES GETS USFDA APPROVAL FOR PHENYLEPHRINE HYDROCHLORIDE INJECTION USP", as attached and enclosed with the regulatory filing as submitted by the company to the Indian Bourses, it further read that, Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT) Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine Hydrochloride injection USP, 10 mg/mL Single-Dose Vial, 50 mg/5 mL (10mg/mL) Pharmacy Bulk Package, and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package, a generic therapeutic equivalent version of (RLD), VAZCULEP Injection, of Avadel Legacy Pharmaceuticals LLC.
Phenylephrine Hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
According to IQVIA™ (IMS Health), Phenylephrine Hydrochloride injection USP had US sales data of approximately $45 million for the 12-month period ending Mar 2020.
Caplin Steriles Limited, has developed and filed 17 ANDAs on its own and with partners, with 9 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.
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