JB Chemicals Share in Focus on Securing USFDA Approval for Hypertension Drug

JB Chemicals & Pharmaceuticals Ltd. has received approval from the United States Food and Drug Administration (USFDA) to manufacture and market Bisoprolol Tablets USP in 5 mg and 10 mg strengths. The approval was issued under the Abbreviated New Drug Application (ANDA) route.

As of 9:20 am on April 21, 2025, J B Chemicals and Pharmaceuticals share price was trading at ₹1,654.50, a 0.50% up, down 13.59% over the past six months and 7.88% over the past year.

Generic Version of Zebeta

The product is a generic version of Teva’s Zebeta tablets, which are prescribed for the management of hypertension. Bisoprolol is used to treat high blood pressure and belongs to the beta-blocker class of medications.

Product Details

• Drug name: Bisoprolol Tablets USP
• Strengths approved: 5 mg and 10 mg
• Indication: Management of hypertension
• Brand reference: Zebeta (Teva)

Approval Route

The approval comes through the ANDA process, which allows pharmaceutical companies to market a generic version of a previously approved drug, provided it meets regulatory requirements for safety, efficacy, and bioequivalence.

In a regulatory filing dated April 18, 2025, the company informed the National Stock Exchange of India that it had secured the approval. The announcement was signed by Sandeep Phadnis, Vice President – Secretarial and Company Secretary, JB Chemicals.

Geographic Market

The approval allows JB Chemicals to introduce the product in the United States, one of the largest pharmaceutical markets globally. The company did not provide additional commercial or launch-related details in the announcement.

Read More: KKR Expected to Sell Stake in JB Chemicals: Check Key Details Here

Conclusion

With this USFDA approval, JB Chemicals is cleared to supply Bisoprolol tablets in the US market. The drug will serve as an alternative to the branded version for the treatment of hypertension. No further information regarding timelines or sales projections was disclosed in the filing.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions. 

Investments in the securities market are subject to market risks, read all the related documents carefully before investing.