JB Chemicals & Pharmaceuticals has received USFDA approval for its Supplementary Abbreviated New Drug Application (sANDA) for Atenolol Tablets USP 25 mg. 50 mg. and 100 mg. (anti-hypertensive) manufactured using company's own bulk drug (API). The company had initiated this change as a part of its plan to gradually backward integrate US formulations business. This approval is expected to boost company's US sales.
The company could not commercialize this formulation earlier due to problems associated with external API supplier. This approval will help company supply these formulations with its own API. The company plans to commercialize this product in the next quarter. Currently, the market for this product in US is about USD 70 million.
The company is focused on US business and this approval will help grow its exports.
Shares of the company gained Rs 5.1, or 1.71%, to trade at Rs 303.50. The total volume of shares traded was 8,409 at the BSE (9.59 a.m., Wednesday).