Alembic Pharma Gets USFDA Nod for Cancer Drug; Shares Rise 1.92%

Mumbai, June 19: Alembic Pharmaceuticals has secured tentative approval from the U.S. Food and Drug Administration (USFDA) for Binimetinib Tablets, 45 mg, adding another oncology product to its growing pipeline for the American market.

The approval relates to Alembic’s abbreviated new drug application (ANDA) for a generic version of Mektovi, a drug marketed by Array. Binimetinib is used in the treatment of certain forms of advanced melanoma and is also prescribed in combination therapies for specific patients with metastatic non-small cell lung cancer carrying BRAF mutations.

For Alembic, the development is significant not just because of the product itself but because of its position in the approval queue. The company said it is the first applicant to file its ANDA for the 45 mg strength under Paragraph IV certification, potentially making it eligible for 180 days of generic marketing exclusivity in the United States if the application receives final approval.

That exclusivity period can be valuable. It allows a generic drugmaker to enter the market ahead of competing copies, often translating into stronger pricing and market share during the initial launch phase.

Alembic Pharma Share Price Gains After Regulatory Update

Investors reacted positively to the announcement, pushing the stock higher in afternoon trade.

As of 13:18 IST on June 19, 2026, Alembic Pharmaceuticals shares were trading at ₹764.10, up ₹14.40 or 1.92%. The Alembic Pharma share price gained momentum after the company disclosed the USFDA development, with traders viewing the approval as a potential addition to its future U.S. revenue pipeline.

The company said Binimetinib Tablets have an estimated U.S. market size of about $259 million for the 12 months ended March 2026, citing IQVIA data.

Company Background

Vadodara-based Alembic Pharmaceuticals is one of India’s established pharmaceutical manufacturers, with a presence across branded formulations, generic medicines and active pharmaceutical ingredients.

The company has built a sizeable U.S. generics business over the years and continues to focus on expanding its portfolio through product filings and regulatory approvals. With this latest development, Alembic’s cumulative USFDA tally stands at 242 ANDA approvals, comprising 222 final approvals and 20 tentative approvals.

Conclusion

While tentative approval does not immediately allow commercial sales, it marks an important regulatory milestone and keeps Alembic positioned for a potential future launch in a niche oncology segment.

For investors, the bigger takeaway is the possibility of first-to-file exclusivity and access to a market estimated at more than $250 million annually. Further clarity will emerge once the company receives final approval from the USFDA and outlines its launch plans.

Source:

• https://www.nseindia.com/get-quote/equity/APLLTD/Alembic-Pharmaceuticals-Limited
• https://nsearchives.nseindia.com/corporate/APLLTD_19062026130010_Intimation_to_SE_Press_Release_TA_S.pdf