Caplin Point opens higher on USFDA approval to subsidiary

The stock price of Caplin Point Laboratories surged by more than six per cent in the early trade on Monday, after it reported an approval of injection, given to one of its subsidiaries.

 USFDA approval for Hydrochloride injection is a very important trigger for the company as it enhances its sustainability in the current situation of lockdown. Ropivacaine hydrochloride is a drug, used for local anesthetic purpose during surgery or for acute pain management.

Caplin Steriles Limited is a wholly-owned subsidiary of the company. The investment in this subsidiary was intended to unlock value in the global injectable markets. The subsidiary has been given an approval for its abbreviated new drug application (ANDA) Ropivacaine Hydrochloride injection USP from USFDA. The approval is granted for the range of 0.2 per cent in 40 mg/20 mL (2 mg/mL), 0.5 per cent in 100 mg/20 mL (5 mg/mL), 0.5 per cent in 150 mg/30 mL (5 mg/mL) and 1 per cent in 200 mg/20 mL (10 mg/mL) dosage, which is intended for single-dose vial presentations, a generic therapeutic equivalent version of (RLD), Naropin Injection, of Fresenius Kabi USA LLC. As of end of December 2019, Hydrochloride injection had US sales numbers of up to $34 million.

Caplin Point Laboratories is engaged in the business of generic drug formulation, having strong export market presence and opportunities.