Alembic Limited has filed its quarterly compliance certificate with stock exchanges, fulfilling regulatory obligations under SEBI's depositories framework. The pharmaceutical company submitted the mandatory documentation for the quarter ended 31st March, 2026, demonstrating continued adherence to securities market regulations.

Regulatory Compliance Filing

The company filed a certificate under Regulation 74(5) of the SEBI (Depositories and Participants) Regulations, 2018 with both BSE Limited and the National Stock Exchange of India Limited on 6th April, 2026. This quarterly filing is a mandatory requirement for listed companies to confirm proper handling of dematerialised securities.

Registrar Confirmation

The certificate was issued by MUFG Intime India Private Limited, formerly known as Link Intime India Private Limited, which serves as Alembic Limited's registrar and share transfer agent. The registrar confirmed compliance with dematerialisation procedures during the quarter.

MUFG Intime India confirmed that securities received from depository participants for dematerialisation during Q4 FY26 were properly processed. The registrar verified that all security certificates received were mutilated and cancelled after due verification, with depositories' names substituted in the register of members within prescribed timelines.

Process Verification

The confirmation certificate addresses key compliance areas including:

• Proper acceptance or rejection of securities received for dematerialisation
• Listing confirmation on stock exchanges where existing securities are traded
• Timely processing and verification of security certificates
• Appropriate updating of member registers with depository information

This quarterly filing represents standard regulatory compliance for listed companies, ensuring transparency in the dematerialisation process and maintaining investor confidence in securities handling procedures. The documentation confirms that Alembic Limited's securities operations during Q4 FY26 met all regulatory requirements established by SEBI for depositories and participants.

Alembic Pharmaceuticals Limited has achieved a significant regulatory milestone with the receipt of final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa and Entacapone tablets. This approval represents another step forward in the company's expansion within the competitive US pharmaceutical market.

Product Details and Therapeutic Equivalence

The approved formulation includes multiple strength combinations: 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg. The approved ANDA has been determined to be therapeutically equivalent to Stalevo tablets of Orion Corporation, which are commonly prescribed for the treatment of Parkinson's disease.

Regulatory Achievement Milestone

This latest approval brings Alembic Pharmaceuticals' total number of ANDA approvals from the USFDA to 234, comprising 214 final approvals and 20 tentative approvals. This substantial portfolio of approved generic drug applications demonstrates the company's consistent ability to meet stringent regulatory requirements and successfully navigate the complex approval process for pharmaceutical products in the United States.

Market Implications

The approval for this Parkinson's disease treatment adds to Alembic Pharmaceuticals' growing portfolio of generic medications in the US market. Generic versions of established treatments like Stalevo provide patients with more affordable alternatives while maintaining the same therapeutic efficacy as the original branded products. The combination of Carbidopa, Levodopa and Entacapone works synergistically to manage the symptoms of this neurological condition.

Company Profile

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company with a legacy dating back to 1907. Headquartered in India, the publicly listed company manufactures and markets generic pharmaceutical products globally. The company's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA, and it operates as one of the leaders in branded generics in India with a field force of over 5,500 professionals.