Bharat Serums AND Vaccines Limited

Bharat Serums and Vaccines Limited (BSV) is a prominent biopharmaceutical company based in India, specializing in the development and manufacturing of biological, biotech, and pharmaceutical products. Established in 1971, BSV has over five decades of experience in the industry, focusing on therapeutic areas such as women's health, critical care, and assisted reproductive technology (IUI-IVF).

The company's registered office is located at 3rd Floor, Liberty Tower, Plot No. K-10, Behind Reliable Plaza, Kalwa Industrial Estate, Airoli, Navi Mumbai, Maharashtra 400 708, India. BSV operates as a public unlisted company, with a Corporate Identification Number (CIN) of U24230MH1971PLC015134. As of the latest available data, the company employs approximately 2,366 individuals.

BSV operates multiple manufacturing facilities in India, including WHO-GMP certified plants in Maharashtra and PICS-approved facilities in Brazil. These facilities are equipped to produce a diverse range of pharmaceutical formulations, including injectables, novel drug delivery systems, and biologicals.

The leadership team at BSV includes:

• Bharat V. Daftary: Chairman & Managing Director

• Sanjiv Hari Navangul: Chief Executive Officer (appointed on 7 February 2025)

• Chirag Ashokbhai Mehta: Chief Financial Officer and Head of Legal & IT (appointed on 22 September 2021)

BSV has established a significant presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has obtained various regulatory approvals, such as WHO-GMP certifications for its manufacturing facilities, enabling access to these markets. Additionally, BSV has a wholly owned subsidiary in the United States, indicating a strategic approach to market penetration.

BSV has expanded its footprint into emerging markets across Africa, Latin America, and Southeast Asia. The company's WHO prequalification and EU GMP certifications have facilitated access to these regions, allowing BSV to offer its products to a broader patient base.

BSV's geographic strategy demonstrates a balanced approach, with a strong presence in both regulated and emerging markets. The company's diversification across various regions mitigates concentration risk and aligns with its strategic direction to enhance global accessibility to its products.

BSV's manufacturing facilities are registered with the U.S. Food and Drug Administration (FDA), and the company has filed Abbreviated New Drug Applications (ANDAs) for its products. The facilities have undergone FDA inspections, ensuring compliance with U.S. regulatory standards. BSV's adherence to FDA requirements underscores its commitment to maintaining high-quality manufacturing practices.

BSV's manufacturing facilities hold WHO-GMP certifications, affirming compliance with international quality standards. The company also possesses EU GMP certificates, enabling it to market its products within the European Union. These certifications reflect BSV's dedication to producing high-quality pharmaceutical formulations.

BSV holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) in India, authorizing the production of pharmaceutical formulations. The company has obtained approvals from state drug controllers and export No Objection Certificates (NOCs), facilitating the export of its products to various international markets.

As of March 2026, there have been no publicly reported Form 483 observations, warning letters, or import alerts issued to BSV by regulatory authorities. This indicates the company's consistent compliance with regulatory standards and its commitment to maintaining high-quality manufacturing practices.

BSV operates in a competitive landscape with several key players in the biopharmaceutical industry. Top competitors include Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., Aurobindo Pharma Ltd., Cipla Ltd., Zydus Lifesciences Ltd., and Lupin Ltd. BSV's focus on specialized therapeutic areas such as women's health, critical care, and IUI-IVF differentiates it from competitors, allowing it to carve out a niche in the market.

BSV's unique strengths include its extensive product portfolio, which encompasses plasma derivatives, monoclonals, fertility hormones, antifungals, anesthetics, cardiovascular drugs, and equine immunoglobulin/antitoxins. The company's commitment to research and development, with a dedicated center housing over 60 scientists, drives innovation and addresses unmet medical needs.

BSV's current strategic direction focuses on expanding its presence in generics, specialty pharmaceuticals, and biosimilars. The company's robust R&D capabilities and regulatory certifications position it well for future growth in these areas. BSV's strategic initiatives aim to enhance its global footprint and deliver innovative healthcare solutions to a broader patient population.

BSV has a strong track record in manufacturing and exporting pharmaceutical formulations, with a total export value of $40.1 million USD across 853 shipments. The company's portfolio includes four products across three therapeutic categories, with a concentration in antifungals and other categories. BSV's consistent export volume and adherence to international quality standards underscore its reliability as a supplier.

Importers should verify the following certifications when considering BSV as a supplier:

• FDA Facility Registration: Confirm the registration status of BSV's manufacturing facilities with the U.S. FDA.

• WHO-GMP Certification: Ensure that BSV's manufacturing facilities hold valid WHO-GMP certifications.

• EU GMP Certification: Verify the EU GMP certification status of BSV's manufacturing facilities.

• ISO Certifications: Check for relevant ISO certifications related to quality management systems.

These certifications can typically be verified through the respective regulatory bodies' official websites or by contacting BSV directly.

When conducting due diligence on BSV, consider the following steps:

• Regulatory Compliance: Verify the validity of BSV's FDA, WHO-GMP, EU GMP, and ISO certifications.

• Financial Health: Review BSV's financial statements and credit history to assess financial stability.

• Quality Assurance: Evaluate BSV's quality control processes and inspection history to ensure product quality.

• Supply Chain Reliability: Assess BSV's supply chain capabilities and delivery performance.

Red flags to watch for include expired certifications, unresolved regulatory issues, and inconsistent financial performance. Recommended pre-order checks involve obtaining recent inspection reports and verifying the authenticity of certifications through official channels.