Marksans pharma Limited has submitted its quarterly compliance certificate under SEBI Regulation 74(5) for the quarter ended March 31, 2026. The pharmaceutical company filed the mandatory documentation with both BSE and NSE on April 09, 2026, demonstrating its commitment to regulatory compliance.

Regulatory Compliance Details

The certificate was issued by Bigshare Services Private Limited, the company's appointed Registrar and Transfer Agent, on April 06, 2026. This documentation is required under the SEBI (Depositories and Participants) Regulations, 2018, specifically addressing the proper handling of securities dematerialization processes.

Certificate Confirmation

Bigshare Services confirmed that all securities received from depository participants for dematerialization up to March 31, 2026 were properly processed. The registrar verified that:

• Securities received for dematerialization were confirmed to depositories within regulatory timelines
• All securities are listed on stock exchanges where the company's earlier issued securities are traded
• Security certificates received for dematerialization were mutilated and cancelled after proper verification
• Depository names were substituted in the register of members as registered owners within 15 days of certificate receipt

Stock Exchange Communication

The company communicated with both major Indian stock exchanges regarding this compliance filing. BSE Limited received the documentation at its Corporate Relation Department, while NSE's Listing Department was notified of the regulatory submission.

Corporate Information

Marksans Pharma Limited operates from its registered office located at the 11th Floor, Grandeur, Veera Desai Extension Road, Oshiwara, Andheri West, Mumbai. The company maintains regular communication with stakeholders through its dedicated investor relations channels and ensures timely compliance with all regulatory requirements.

Marksans Pharma has secured a significant regulatory milestone with the United States Food and Drug Administration (USFDA) granting final approval for its Abbreviated New Drug Application (ANDA) for Benzonatate Capsules USP in two different strengths. The company announced this development through an official press release under Regulation 30 to the stock exchanges.

USFDA Approval Details

The pharmaceutical company has received approval for Benzonatate Capsules USP in both 100 mg and 200 mg formulations. According to the official announcement, this product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Tessalon Capsules of Pfizer Inc.

Therapeutic Significance

Benzonatate is a non-narcotic antitussive that works by numbing stretch receptors in the respiratory tract, thereby reducing the cough reflex and providing relief from persistent cough. The medication is particularly effective in treating conditions such as bronchitis, pneumonia, and other lung infections where cough suppression is required.

Regulatory Compliance and Market Impact

Receiving USFDA approval demonstrates Marksans Pharma's ability to meet the stringent quality and safety standards required by one of the world's most rigorous pharmaceutical regulatory bodies. The bioequivalence to Pfizer's reference product further validates the quality and efficacy of the company's formulation.

The approval of these Benzonatate Capsules USP formulations adds to Marksans Pharma's growing portfolio of USFDA-approved pharmaceutical products, strengthening its position in the competitive US pharmaceutical market. The company's manufacturing facilities in India, USA, and UK are approved by several leading regulatory agencies including USFDA, UKMHRA, and Australian TGA.