Strides Arcolab Limited (Strides) has received 2 ANDA approvals from US FDA for bupivacaine hydrochloride injection, USP, a general anaesthetic for the following strengths: bupivacaine hydrochloride injection, USP, 0.25per cent, 0.5 per cen and 0.75 per cent packaged in 10 mL and 30 mL Single-dose Vials (Preservative Free) and bupivacaine hydrochloride injection, USP, 0.25 per cent (2.5 mg/ mL) and 0.5 per cent (5 mg/ mL) each packaged in 50 mL Multiple-dose Vials.

According to IMS, the 2011 US market for injectable bupivacaine hydrochloride approximates to US$ 29 million. The product is expected to be launched shortly.

Bupivacaine is the thirteenth product approved under the Sagent - Strides partnership. Strides is developing and supplying more than 25 injectable products for the USA market which will be marketed by Sagent.

Bupivacaine hydrochloride is indicated for the production of local or regional anaesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25 per cent and 0.5 per cent concentrations are indicated for obstetrical anaesthesia.

Agila is the specialties unit of Strides Arcolab which was spun off as a separate division post the Company’s restructuring in 2009. It is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from 8 world class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world.

Strides Arcolab is a global pharmaceutical company that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.