Caplin Steriles gets USFDA approval for Verapamil Hydrochloride Injection

Chennai: Caplin Steriles Limited, a Wholly Owned 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) 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.

According to IQVIATM (IMS Health), Verapamil Hydrochloride injection USP had US sales data of approximately US$28 million for the 12-month period ending Dec 2019.

Verapamil Hydrochloride is a calcium channel blocker used in the treatment of cardiac conditions such as high blood pressure, arrhythmias, and angina.

Caplin Steriles Limited has developed and filed 15 ANDAs on its own and with partners, with 7 approvals so far. Mr.C.C.Paarthipan, Chairman of Caplin Point Laboratories Limited commented "We are pleased to receive another approval under Caplin Steriles name and we would be launching this product in the US soon. We're also expecting a couple more approvals shortly, which should enhance our revenue traction in the US."

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. 

Read also: Caplin Point subsidiary receives USFDA approval for Sodium Nitroprusside injection to reduce BP

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 has state of the art manufacturing facilities that cater to a complete range of finished dosage forms. The Company's Wholly Owned Subsidiary Caplin Steriles Limited caters to the Regulated Markets for Injectable and Ophthalmic products. 

Caplin Point Laboratories Limited has been selected on Forbes Asia's "200 Best Under a Billion" list for three consecutive years (2014, 2015 & 2016).

Read also: USFDA grants final nod to Caplin Point arm for Tranexamic Acid Injection