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.

Marksans pharma Limited has announced the opening of a special window for shareholders to re-lodge transfer requests for physical shares, following regulatory guidelines from the Securities and Exchange Board of India. The initiative addresses long-pending transfer issues for shares purchased or sold before April 1, 2019.

SEBI Regulatory Framework

The special window operates under SEBI Circular No. HO/38/13/11(2)2026-MIRSD-POD/I/3750/2026 dated January 30, 2026. The regulatory framework specifically targets transfer deeds that were previously rejected, returned, or not attended to due to deficiencies in transfer documents or other procedural issues.

Transfer Process and Requirements

Shareholders seeking to utilize this facility must submit comprehensive documentation to ensure proper transfer registration. The company has specified that successful transfers will result in shares being credited exclusively in demat mode, with no physical share certificates issued.

The mandatory documentation requirements include:

• Original share certificate
• Transfer deed executed prior to April 1, 2019
• Proof of purchase by transferee
• KYC documents of the transferee as per ISR forms
• Latest Client Master List of the demat account, duly attested by the depository participant
• Undertaking cum Indemnity in prescribed format
• Additional documents as required on case-by-case basis

Lock-in Period and Restrictions

Transferred shares will be subject to specific restrictions designed to ensure regulatory compliance. The company has outlined clear parameters for share movement post-transfer.

Contact Information and Support

Shareholders requiring assistance can contact the company's Registrar and Share Transfer Agent, Bigshare Services Private Limited, located at Office No. S6-2, 6th Floor, Pinnacle Business Park, Andheri (East), Mumbai – 400093. The RTA can be reached at 022 62638200 or via email at info@bigshareonline.com .

For direct company queries, shareholders may contact the Company Secretary at companysecretary@marksanspharma.com or reach Mr. Atul Shukla at 022 4001 2000. The undertaking cum indemnity format can be downloaded from the company's website at www.marksanspharma.com .