Gland Pharma Limited has secured regulatory approval from the United States Food and Drug Administration (USFDA) for its Zoledronic Acid injection, marking a significant milestone in the company's oncology portfolio expansion. The approval was formally communicated to stock exchanges under Regulation 30 of SEBI listing requirements.

Product Specifications and Regulatory Details

The company received approval for its Abbreviated New Drug Application (ANDA) for Zoledronic Acid injection with specific formulation parameters:

Expanded Therapeutic Applications

The approved injection addresses three critical cancer-related conditions, representing an expansion from the initially projected two indications. The product is indicated for treating:

• Hypercalcemia of Malignancy
• Multiple Myeloma
• Bone Metastases of Solid Tumors

This broader therapeutic scope enhances the product's market potential and clinical utility in oncology care, providing healthcare providers with treatment options for various cancer-related bone complications.

Market Performance Data

According to IQVIA data, the market performance for this product category shows established commercial activity:

Regulatory Compliance and Communication

Gland Pharma formally notified both major Indian stock exchanges about this development in compliance with regulatory requirements. The company communicated the approval to BSE Limited (Scrip Code: 543245) and National Stock Exchange of India Limited (Symbol: GLAND, ISIN: INE068V01023) under Regulation 30 of SEBI listing obligations.

Strategic Market Position

This USFDA approval strengthens Gland Pharma's position as a leading injectable-focused pharmaceutical company with global operations across 60 countries. The company, established in 1978 and headquartered in Hyderabad, has evolved from a contract manufacturer to become one of the largest injectable-focused companies globally, operating primarily under a business-to-business model with expertise in sterile injectables including vials, ampoules, pre-filled syringes, and oncology solutions.

Gland pharma Limited has announced a significant change in its senior management team with the upcoming retirement of Chief Operating Officer Mr. Satnam Singh Loomba. The pharmaceutical company informed stock exchanges about this leadership transition in compliance with regulatory requirements.

Leadership Transition Details

The company has disclosed that Mr. Satnam Singh Loomba will retire from his position as Chief Operating Officer effective March 31, 2026, due to superannuation. This announcement was made in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Service Tenure and Recognition

Mr. Loomba has been associated with Gland Pharma since May 01, 2024, serving in the capacity of Chief Operating Officer. Despite his relatively short tenure of less than two years, the company has acknowledged his contributions to the organization.

The Board of Directors of the company and the entire Gland Pharma family have placed on record their sincere appreciation for the leadership and contribution of Mr. Satnam Singh Loomba during his service period.

Regulatory Compliance

The announcement demonstrates Gland Pharma's commitment to maintaining transparency with stakeholders and adhering to regulatory requirements. The disclosure was made to both major Indian stock exchanges:

• BSE Limited: Scrip Code 543245
• National Stock Exchange: Symbol GLAND (ISIN: INE068V01023)

The company has provided all necessary details as required under SEBI regulations, ensuring complete compliance with listing obligations and disclosure requirements. This includes comprehensive information about the change in senior management personnel and the circumstances surrounding the retirement.

Corporate Structure

Following Mr. Loomba's retirement, he will cease to hold the position of Senior Management Personnel within the company structure. The pharmaceutical company, headquartered in Hyderabad, Telangana, continues to maintain its operations across multiple facilities in the region.

The announcement was signed by Sampath Kumar Pallerlamudi, Company Secretary and Compliance Officer, demonstrating proper corporate governance procedures in communicating significant organizational changes to stakeholders and regulatory authorities.