Alembic Pharmaceuticals Limited (APL) has received a vote of confidence from CRISIL Ratings Limited, as the credit rating agency reaffirmed the company's AA+/Stable credit rating for its bank loan facilities. This development comes with an enhancement in the rated amount from Rs. 600.00 crores to Rs. 800.00 crores, while maintaining the company's overall borrowing limit.

Credit Rating Reaffirmation

The reaffirmation of the AA+/Stable rating applies to Alembic Pharmaceuticals' long-term bank loan facilities. This rating indicates a high degree of safety regarding timely servicing of financial obligations and very low credit risk, reflecting the company's strong financial position and creditworthiness.

Enhanced Loan Limit

While the rated amount has been increased by Rs. 200.00 crores, it's important to note that the company's overall borrowing limit remains unchanged. This suggests that Alembic Pharmaceuticals has restructured its borrowing mix, potentially to optimize its financial strategy.

Company's Disclosure

In compliance with regulatory requirements, Alembic Pharmaceuticals has formally notified the stock exchanges about this development. As per the LODR (Listing Obligations and Disclosure Requirements) data, the company stated:

"CRISIL Ratings Limited (CRISIL) vide its letter dated 25th July, 2025, has reaffirmed its Credit Rating on Bank Loan facilities with Enhanced Limits. Although, our rating amount for the following category of borrowing have been enhanced, the overall borrowing limit remains unchanged."

Recent Developments

It's worth noting that Alembic Pharmaceuticals has been making strides in its pharmaceutical business. According to the LODR data, the company recently received US Food & Drug Administration (USFDA) Final Approval for Carbamazepine Extended-Release Tablets USP in various strengths. This approval adds to the company's growing portfolio of ANDA (Abbreviated New Drug Application) approvals, which now stands at a cumulative total of 225, including 202 final approvals and 23 tentative approvals from the USFDA.

The reaffirmation of Alembic Pharmaceuticals' credit rating, along with the enhanced loan limit and recent regulatory approvals, indicates the company's solid financial footing and ongoing growth in its pharmaceutical operations. These developments may position the company well for future expansion and market opportunities in the pharmaceutical sector.

Alembic Pharmaceuticals Limited (APL) has achieved a significant milestone in its pharmaceutical portfolio with the recent approval from the United States Food and Drug Administration (US FDA) for its Carbamazepine Extended-Release Tablets USP. The approval covers three strengths: 100 mg, 200 mg, and 400 mg.

Product Details and Market Potential

The newly approved drug is therapeutically equivalent to Novartis' Tegretol-XR, a well-established medication in the market. Carbamazepine Extended-Release Tablets are primarily indicated for use as an anticonvulsant and for treating pain associated with trigeminal neuralgia.

According to IQVIA data, the approved tablets have an estimated market size of US$ 71.00 million for the twelve months ending March 2025, presenting a substantial opportunity for Alembic Pharmaceuticals in the US market.

Expanding FDA Approvals Portfolio

This latest approval marks a significant addition to Alembic's growing list of FDA-approved products. With this new approval, the company's tally of Abbreviated New Drug Application (ANDA) approvals from the US FDA has reached 225. This total comprises 202 final approvals and 23 tentative approvals, showcasing Alembic's strong pipeline and regulatory success in the US pharmaceutical market.

Company Background

Alembic Pharmaceuticals Limited, headquartered in Vadodara, India, has been a prominent player in the healthcare sector since 1907. The company is known for its vertically integrated research and development capabilities in the pharmaceutical industry. Alembic manufactures and markets generic pharmaceutical products globally, with state-of-the-art research and manufacturing facilities approved by regulatory authorities of many developed countries, including the US FDA.

In India, Alembic has established itself as one of the leaders in branded generics, with its products well-recognized by doctors and patients. The company's extensive field force of over 5,500 representatives contributes to its strong market presence.

This latest FDA approval for Carbamazepine Extended-Release Tablets further solidifies Alembic Pharmaceuticals' position in the global pharmaceutical market, particularly in the United States, and demonstrates the company's ongoing commitment to expanding its product portfolio in key therapeutic areas.