Alembic Pharmaceuticals Limited has officially notified stock exchanges regarding the resignation of a senior management personnel. The pharmaceutical company informed BSE and NSE about the departure of Mr. Nilesh Wadhwa from his position as Head - Formulation Business Development, effective March 31, 2026.

Regulatory Compliance and Documentation

The company filed the intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, ensuring full compliance with regulatory requirements. Company Secretary Manisha Saraf signed the official communication to both stock exchanges on March 31, 2026.

Timeline of Resignation Process

The resignation process began when Mr. Wadhwa submitted his resignation letter on December 16, 2025, addressed to Managing Director Mr. Pranav Amin. In his letter, he expressed gratitude for the leadership and support received during his tenure, stating his intention to resign from the position of Head of International Business and Strategy.

Company's Response and Acceptance

Alembic Pharmaceuticals formally acknowledged and accepted the resignation through a letter dated December 31, 2025, signed by Shant Mankodi, Head-Human Resources. The acceptance letter confirmed that Mr. Wadhwa would be discharged from his duties effective March 31, 2026, after office hours.

The company noted that the acceptance letter was not a formal relieving letter, with the official relieving documentation to be provided upon settlement of dues and handover of responsibilities on the last working day.

Professional Transition

In his resignation communication, Mr. Wadhwa emphasized his continued commitment to the organization during the transition period and expressed appreciation for the opportunities for learning and professional growth. He assured the management of his support for a smooth transition process until his departure date.

The company has completed all necessary regulatory filings and documentation related to this senior management change, maintaining transparency with stakeholders and regulatory authorities.

Alembic Pharmaceuticals has achieved another regulatory milestone with the US FDA granting final approval for its supplemental Abbreviated New Drug Application (sANDA) for Paroxetine Extended-Release Tablets USP, 12.5 mg. This approval marks a significant addition to the company's growing portfolio of generic pharmaceutical products in the United States market.

FDA Approval Details

The newly approved Paroxetine Extended-Release tablets are therapeutically equivalent to the reference listed drug product (RLD), Paxil CR Tablets, 12.5 mg, of Apotex Inc. This approval demonstrates Alembic Pharmaceuticals' capability to develop and manufacture complex generic formulations that meet stringent FDA standards.

Therapeutic Applications

Paroxetine extended-release tablets are indicated for the treatment of multiple conditions including Major depressive disorder (MDD), Panic disorder (PD), Social anxiety disorder (SAD), and Premenstrual dysphoric disorder (PMDD). This broad therapeutic scope positions the product as a valuable addition to Alembic's central nervous system portfolio.

Expanding US Portfolio

With this latest approval, Alembic Pharmaceuticals has now accumulated a cumulative total of 235 US ANDA approvals, comprising 216 final approvals and 19 tentative approvals. This substantial portfolio reflects the company's consistent efforts in developing generic alternatives to branded medications, providing more affordable treatment options for patients in the American healthcare system.

Strategic Significance

The approval of Paroxetine Extended-Release tablets adds to Alembic Pharmaceuticals' therapeutic offerings in the central nervous system segment. Extended-release formulations require sophisticated manufacturing capabilities and regulatory expertise, highlighting the company's technical competencies in pharmaceutical development and production at its state-of-the-art facilities approved by regulatory authorities including the USFDA.