Alembic Pharmaceuticals Limited has filed its quarterly compliance certificate with stock exchanges, fulfilling mandatory regulatory requirements under SEBI regulations. The pharmaceutical company submitted the certificate on 8th April, 2026, covering the quarter ended 31st March, 2026.

Regulatory Compliance Filing

The company filed a Certificate under Regulation 74(5) of the SEBI (Depositories and Participants) Regulations, 2018 with both BSE and NSE. Company Secretary Manisha Saraf signed the filing, which was submitted to ensure compliance with securities market regulations.

Registrar Confirmation

MUFG Intime India Private Limited, formerly known as Link Intime India Private Limited, serves as the registrar and share transfer agent for Alembic Pharmaceuticals. The registrar issued the compliance certificate on April 3, 2026, confirming proper handling of securities dematerialisation processes.

Ashok Shetty, Sr. Vice President-Corporate Registry at MUFG Intime India, signed the certificate confirming that:

• Securities received from depository participants for dematerialisation during the quarter were properly confirmed
• Security certificates received were mutilated and cancelled after due verification
• Depository names were substituted in the register of members within prescribed timelines
• All securities are listed on stock exchanges where earlier issued securities are listed

Stock Exchange Details

The filing was submitted to both major Indian stock exchanges where Alembic Pharmaceuticals shares are traded.

This routine compliance filing demonstrates the company's adherence to SEBI regulations governing depositories and participants, ensuring transparent and proper handling of shareholder securities during the dematerialisation process.

Alembic Pharmaceuticals Limited has officially announced receiving final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets in 5 mg and 10 mg strengths. The company made this announcement through a regulatory filing under Regulation 30 to the stock exchanges.

Regulatory Approval and Market Position

The approved ANDA is therapeutically equivalent to the reference listed drug product Farxiga Tablets of AstraZeneca AB. Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor with dual therapeutic indications for adults with type 2 diabetes mellitus.

Generic Drug Exclusivity Benefits

Alembic Pharmaceuticals was among the first ANDA applicants to submit a substantially complete application with paragraph IV certification for Dapagliflozin Tablets. This strategic positioning has earned the company eligibility for 180 days of shared generic drug exclusivity, providing a competitive advantage during the initial market launch period.

Market Opportunity and Commercial Impact

According to IQVIA data, Dapagliflozin tablets in 5 mg and 10 mg strengths represent an estimated market size of USD 10,487 million for the twelve months ending December 2025. This substantial market opportunity reinforces the commercial significance of the USFDA approval for Alembic Pharmaceuticals.

Regulatory Portfolio Expansion

With this latest approval, Alembic Pharmaceuticals has achieved a cumulative total of 235 ANDA approvals from the USFDA, comprising 217 final approvals and 18 tentative approvals. This milestone demonstrates the company's consistent regulatory success and strengthens its position in the US generic pharmaceutical market.

Therapeutic Applications

The approved Dapagliflozin tablets serve dual therapeutic purposes for adults with type 2 diabetes mellitus. The medication is indicated to reduce the risk of hospitalization for heart failure in patients with established cardiovascular disease or multiple cardiovascular risk factors, and as an adjunct to diet and exercise for improving glycemic control.