BAL Pharma Limited

Bal Pharma Limited, established in 1987, is a prominent Indian pharmaceutical company headquartered in Bengaluru, Karnataka. The company specializes in the manufacturing and marketing of pharmaceutical formulations and active pharmaceutical ingredients (APIs), offering a diverse portfolio that includes prescription drugs, generics, over-the-counter (OTC) products, intravenous infusions, and bulk drugs.

As of March 2025, Bal Pharma reported a workforce of 715 employees. The company is publicly listed on the Bombay Stock Exchange under the ticker symbol 524824 and on the National Stock Exchange of India as BALPHARMA. In the fiscal year ending March 2025, Bal Pharma reported a revenue of approximately ₹2,348.39 million.

Bal Pharma operates six state-of-the-art manufacturing facilities across India, each specializing in different aspects of pharmaceutical production. Unit 1 in Bengaluru focuses on the production of tablets and capsules, with an annual capacity of 1.80 billion tablets and 200 million capsules. Unit 2, also in Bengaluru, is dedicated to the manufacturing of APIs, with an annual capacity of 60 tonnes of mixed products. Unit 3 in Pune specializes in intravenous fluids, ophthalmic preparations, and liquid oral preparations, with an annual capacity of 18 million vials, 6 million IV bottles, and 5 million syrup bottles. Unit 4 in Rudrapur focuses on tablets, capsules, creams, gels, and ointments, with an annual capacity of 1.80 billion tablets, 300 million capsules, and 20 million tubes. Unit 5 in Sangli is dedicated to the production of intermediates, and Unit 6 in Udaipur focuses on other pharmaceutical products.

The leadership team at Bal Pharma Limited is headed by Managing Director and Executive Director Shailesh Dheerajmal Siroya. The Chief Financial Officer is Daddanala Venkat Bharath Bhushan. Other key executives include Archana Dubey Mitra, serving as the Chief Operating Officer, and Himesh Virupakshaya, a Whole Time Director. The company also has a Deputy General Manager of Internal Audit, Legal and Compliance, Ravindra Kumar Kothari, and a Company Secretary and Compliance Officer, Abdul Basith.

Bal Pharma Limited has made significant strides in entering regulated markets, particularly in the European Union (EU). The company's manufacturing facility in Rudrapur has received EU Good Manufacturing Practice (GMP) approval, indicating compliance with stringent EU standards. Additionally, the company has obtained approvals from various international regulatory bodies, including the Therapeutic Goods Administration (TGA) of Australia, the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, the Ministry of Health (MOH) of Canada, the Korea Food and Drug Administration (KFDA), and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) of Mexico. These approvals facilitate Bal Pharma's market access in these regions, allowing the company to export its products to a broader international audience.

In the United States, Bal Pharma has filed a Drug Master File (DMF) for Bepotastine API with the U.S. Food and Drug Administration (FDA), demonstrating its commitment to meeting U.S. regulatory standards. This filing is a crucial step for the company to gain market access in the U.S., a key regulated market.

Bal Pharma Limited has a strong presence in emerging markets, exporting its products to approximately 30 countries across Africa, Latin America, Southeast Asia, and the Middle East. The company's manufacturing facilities, such as Unit 3 in Pune, are approved by regulatory authorities in countries like Zimbabwe, Nigeria, and Yemen, enabling access to these markets. Additionally, the company's API and finished dosage forms (FDF) are exported to Europe, the Far East, Latin America, Africa, the Middle East, and other global markets, indicating a diversified export strategy.

Bal Pharma Limited's geographic strategy involves a diversified approach, with a significant portion of its exports directed towards emerging markets in Africa, Latin America, Southeast Asia, and the Middle East. This diversification helps mitigate risks associated with over-reliance on a single market and allows the company to tap into the growing demand for pharmaceutical products in these regions. The company's manufacturing facilities are strategically located to cater to both domestic and international markets, with approvals from various international regulatory bodies facilitating market access.

Bal Pharma Limited has taken steps to enter the U.S. market by filing a Drug Master File (DMF) for Bepotastine API with the U.S. Food and Drug Administration (FDA). This filing is a critical component for obtaining FDA approval and gaining market access in the United States. The company's manufacturing facilities have received approvals from various international regulatory bodies, including the TGA of Australia, the PMDA of Japan, the MOH of Canada, the KFDA, and COFEPRIS of Mexico, indicating a commitment to meeting global regulatory standards.

Bal Pharma Limited's manufacturing facility in Rudrapur has received EU Good Manufacturing Practice (GMP) approval, demonstrating compliance with stringent EU standards. Additionally, the company's manufacturing facilities have received approvals from various international regulatory bodies, including the TGA of Australia, the PMDA of Japan, the MOH of Canada, the KFDA, and COFEPRIS of Mexico, indicating a commitment to meeting global regulatory standards.

Bal Pharma Limited holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) in India, ensuring compliance with national regulatory standards. The company's manufacturing facilities are approved by various international regulatory bodies, including the TGA of Australia, the PMDA of Japan, the MOH of Canada, the KFDA, and COFEPRIS of Mexico, facilitating market access in these countries.

As of March 2026, there are no publicly available records of FDA Form 483 observations, warning letters, or import alerts issued to Bal Pharma Limited. The company's manufacturing facilities have received approvals from various international regulatory bodies, including the TGA of Australia, the PMDA of Japan, the MOH of Canada, the KFDA, and COFEPRIS of Mexico, indicating compliance with global regulatory standards.

Bal Pharma Limited operates in a competitive landscape, with several key players in the pharmaceutical industry offering similar products. The company's focus on APIs and finished formulations, along with its diversified export strategy targeting emerging markets, positions it favorably in the global market. The company's manufacturing facilities have received approvals from various international regulatory bodies, including the TGA of Australia, the PMDA of Japan, the MOH of Canada, the KFDA, and COFEPRIS of Mexico, facilitating market access in these regions.

Bal Pharma Limited's key differentiators include its diversified product portfolio, encompassing prescription drugs, generics, OTC products, intravenous infusions, and bulk drugs. The company's focus on APIs and finished formulations, along with its diversified export strategy targeting emerging markets, positions it favorably in the global market. The company's manufacturing facilities have received approvals from various international regulatory bodies, including the TGA of Australia, the PMDA of Japan, the MOH of Canada, the KFDA, and COFEPRIS of Mexico, facilitating market access in these regions.

Bal Pharma Limited's current strategic direction involves a diversified approach, with a significant portion of its exports directed towards emerging markets in Africa, Latin America, Southeast Asia, and the Middle East. The company's focus on APIs and finished formulations, along with its diversified export strategy targeting emerging markets, positions it favorably in the global market. The company's manufacturing facilities have