Biocon Pharma Limited

Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, was incorporated on October 31, 2014, under the Corporate Identification Number (CIN) U24232KA2014PLC077036. The company is headquartered in Bengaluru, Karnataka, India, at 20th KM, Hosur Road, Bengaluru – 560100. Biocon Pharma Limited specializes in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. As of March 2023, Biocon Limited, the parent company, employed approximately 16,545 individuals. Biocon Pharma Limited's website is accessible at www.biocon.com.

Biocon Pharma Limited operates five state-of-the-art manufacturing facilities across India, located in Bengaluru, Hyderabad, and Visakhapatnam. These facilities are designed to manufacture high-quality products efficiently and reliably. The manufacturing plants are approved by various international regulatory bodies, including the US FDA, EMA, COFEPRIS, TGA, and ANVISA. The facilities are equipped with advanced technologies such as microbial fermentation, chemical synthesis, peptide synthesis, and high-potent active pharmaceutical ingredients (HPAPIs) production.

Biocon Limited, the parent company of Biocon Pharma Limited, is led by a team of experienced executives. Kiran Mazumdar-Shaw serves as the Executive Chairperson, guiding the company's strategic direction. Siddharth Mittal holds the position of Chief Executive Officer and Managing Director, overseeing daily operations and business development. Mukesh Kamath K serves as the Interim Chief Financial Officer and Nodal Officer, managing financial strategies and compliance.

Biocon Pharma Limited has established a significant presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has received approvals from the US FDA for various products, including Everolimus Tablets for Oral Suspension on January 12, 2026, and Tofacitinib Extended-Release Tablets on November 19, 2025. In the UK, Biocon Pharma Limited received a Good Manufacturing Practice (GMP) compliance certificate from the Medicines & Healthcare products Regulatory Agency (MHRA) on April 12, 2021, for its manufacturing facility at Biocon Park in Bengaluru. These approvals and certifications demonstrate the company's commitment to meeting international regulatory standards and expanding its global footprint.

Biocon Pharma Limited has made strategic inroads into emerging markets, including Africa, Latin America, and Southeast Asia. The company's focus on affordable innovation has enabled it to address unmet medical needs in these regions. By obtaining World Health Organization (WHO) prequalification for certain products, Biocon Pharma Limited has facilitated access to these markets, ensuring that its high-quality medicines are available to a broader patient population.

Biocon Pharma Limited's geographic strategy emphasizes diversification and global expansion. The company's manufacturing facilities in India serve as a hub for supplying products to over 120 countries worldwide. The recent inauguration of its first US manufacturing facility in Cranbury, New Jersey, in September 2025, reflects a strategic move to strengthen its presence in the North American market. This expansion reduces reliance on a single market and mitigates concentration risk, positioning the company for sustained growth in diverse regions.

Biocon Pharma Limited has achieved significant milestones with the US Food and Drug Administration (FDA). The company has received approvals for various products, including Everolimus Tablets for Oral Suspension on January 12, 2026, and Tofacitinib Extended-Release Tablets on November 19, 2025. Additionally, Biocon Pharma Limited's first US manufacturing facility in Cranbury, New Jersey, inaugurated in September 2025, is approved by the US FDA. These approvals and certifications underscore the company's commitment to meeting stringent regulatory standards and expanding its presence in the US market.

Biocon Pharma Limited has demonstrated compliance with international manufacturing standards. The company received a Good Manufacturing Practice (GMP) compliance certificate from the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK on April 12, 2021, for its manufacturing facility at Biocon Park in Bengaluru. This certification reflects the company's adherence to stringent quality standards and its commitment to delivering high-quality pharmaceutical products to global markets.

Biocon Pharma Limited operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company holds manufacturing licenses from CDSCO, ensuring compliance with national standards for pharmaceutical manufacturing. Additionally, Biocon Pharma Limited has obtained export No Objection Certificates (NOCs) from the Directorate General of Foreign Trade (DGFT), facilitating its export activities. These regulatory approvals affirm the company's adherence to Indian pharmaceutical regulations and its capability to export products internationally.

Biocon Pharma Limited has maintained a strong compliance record with regulatory authorities. The company has not reported any Form 483 observations, warning letters, or import alerts from the US FDA. This clean record indicates the company's commitment to adhering to regulatory standards and maintaining high-quality manufacturing practices.

Biocon Pharma Limited operates in a competitive landscape, with several key players in the pharmaceutical industry. While specific market share data is not available, the company's focus on affordable innovation and high-quality manufacturing positions it as a strong competitor in the global market. The recent expansion into the US market with the inauguration of its first US manufacturing facility in Cranbury, New Jersey, in September 2025, reflects a strategic move to enhance its competitive position.

Biocon Pharma Limited differentiates itself through its commitment to affordable innovation and high-quality manufacturing. The company's integrated approach, encompassing both biosimilars and generic formulations, allows it to address a broad spectrum of therapeutic areas, including oncology, diabetes, and immunology. This comprehensive portfolio enables Biocon Pharma Limited to meet diverse patient needs and strengthen its position in the global pharmaceutical market.

Biocon Pharma Limited's strategic direction focuses on expanding its global footprint through the development and commercialization of biosimilars and generic formulations. The recent inauguration of its first US manufacturing facility in Cranbury, New Jersey, in September 2025, signifies a strategic move to strengthen its presence in the North American market. Looking ahead, the company aims to leverage its manufacturing capabilities and regulatory approvals to drive growth and deliver affordable, high-quality medicines to patients worldwide.

Biocon Pharma Limited has established itself as a reliable supplier in the pharmaceutical industry. The company's manufacturing facilities are approved by various international regulatory bodies, including the US FDA, EMA, COFEPRIS, TGA, and ANVISA, indicating a consistent track record of compliance with global standards. The recent inauguration of its first US manufacturing facility in Cranbury, New Jersey, in September 2025, further demonstrates the company's commitment to expanding its manufacturing capabilities and ensuring a reliable supply chain.

Importers should verify the following certifications when considering Biocon Pharma Limited as a supplier:

• FDA Approval: Confirm that the manufacturing facility is approved by the US Food and Drug Administration (FDA).

• WHO-GMP Certification: Ensure that the manufacturing facility complies with World Health Organization (WHO) Good Manufacturing Practice (GMP) standards.

• EU GMP Certification: Verify that the manufacturing facility adheres to European Union Good Manufacturing Practice (EU GMP) standards.

• ISO Certification: Check for relevant International Organization for Standardization (ISO) certifications, such as ISO 9001 for quality management systems.

These certifications can typically be verified through the respective regulatory agencies' official websites or by requesting documentation directly from Biocon Pharma Limited.

When conducting due diligence on Biocon Pharma Limited, consider the following steps:

• Regulatory Compliance: Verify that the manufacturing facilities hold current approvals from relevant regulatory bodies, including the US FDA,