Boehringer Ingelheim India Private Limited

Boehringer Ingelheim India Private Limited, incorporated on December 11, 2003, is a private unlisted company based in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24230MH2003PTC143499. Its authorized and paid-up capital stands at ₹6.47 crore (approximately $772,000 USD). The registered office is located at Unit No. 202, 2nd Floor, Godrej 2, Pirojsha Nagar, Eastern Express Highway, Vikhroli East, Mumbai, Maharashtra 400079, India.

As a subsidiary of the German multinational pharmaceutical company Boehringer Ingelheim, the Indian entity focuses on the manufacturing and export of finished pharmaceutical formulations. The parent company, Boehringer Ingelheim, was founded in 1885 and is one of the world's largest privately held pharmaceutical companies.

Boehringer Ingelheim India Private Limited operates manufacturing facilities in India, specializing in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company exports two products across two therapeutic categories, with a total export value of $772,000 USD and 42 shipments. The top two products exported are Empagliflozin, with an export value of $682,000 USD and a market share of 10.2%, and Linagliptin, with an export value of $90,000 USD and a market share of 2.3%. The primary therapeutic category is Diabetes & Endocrine, accounting for 88.3% of exports, followed by Advanced Diabetes Medications at 11.7%.

The leadership team of Boehringer Ingelheim India Private Limited includes:

• Sandipkumar Rameshchandra Agrawal: Director since October 11, 2017.

• Sanjay Srivastava: Director since November 21, 2022.

• Shriya Mandar Oak: Director since May 23, 2024.

The Managing Director and Chief Financial Officer positions are not specified in the available sources. For detailed information on the executive team, it is recommended to contact the company directly or consult official corporate filings.

Boehringer Ingelheim India Private Limited's export activities are primarily focused on the United States, European Union, United Kingdom, Australia, and Japan. The company exports finished pharmaceutical formulations, including Empagliflozin and Linagliptin, to these markets. Specific regulatory filings, approvals, and market access statuses for each country are not detailed in the available sources. For comprehensive information, it is advisable to consult the respective regulatory agencies or the company's official communications.

The company's export data does not specify activities in Africa, Latin America, or Southeast Asia. However, Boehringer Ingelheim India Private Limited has a partnership with Alivira Animal Health Limited, a fully owned subsidiary of Viyash Scientific Limited, for the distribution and promotion of its companion animal products portfolio in India. This partnership, announced on January 23, 2026, aims to leverage growth opportunities in the Indian pet healthcare market.

Boehringer Ingelheim India Private Limited's export portfolio is highly concentrated, with the top two products—Empagliflozin and Linagliptin—accounting for 100% of exports. This indicates a lack of diversification in the product range, which could pose risks if market dynamics change. The company's strategic direction appears to focus on the diabetes and endocrine therapeutic areas, aligning with global trends in the pharmaceutical industry. To mitigate concentration risks, exploring additional therapeutic categories and expanding the product portfolio could be beneficial.

Specific details regarding Boehringer Ingelheim India Private Limited's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not available in the provided sources. For accurate and up-to-date information, it is recommended to consult the FDA's official database or contact the company directly.

The available sources do not provide information on Boehringer Ingelheim India Private Limited's World Health Organization (WHO) prequalification status, European Union Good Manufacturing Practice (EU GMP) certificates, or European Directorate for the Quality of Medicines & HealthCare (EDQM) status. For detailed certifications, it is advisable to refer to the company's official communications or contact the relevant regulatory bodies.

Specific details regarding Boehringer Ingelheim India Private Limited's Central Drugs Standard Control Organisation (CDSCO) manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not available in the provided sources. For comprehensive information, consulting the CDSCO or the company's official communications is recommended.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Boehringer Ingelheim India Private Limited. For the most current information, it is advisable to consult the FDA's official database or contact the company directly.

In the diabetes and endocrine therapeutic categories, Boehringer Ingelheim India Private Limited faces competition from several global and local pharmaceutical companies. While specific market share data is not available, companies such as Novo Nordisk, Sanofi, and Merck are prominent players in these segments. A detailed head-to-head analysis would require access to proprietary market research data.

Boehringer Ingelheim India Private Limited's focus on the diabetes and endocrine therapeutic areas positions it to address the growing global prevalence of these conditions. The partnership with Alivira Animal Health Limited enhances its presence in the Indian pet healthcare market, diversifying its portfolio beyond human pharmaceuticals. These strategic initiatives may provide a competitive edge in the evolving healthcare landscape.

The company's current strategic direction emphasizes the diabetes and endocrine therapeutic areas, with a recent expansion into the animal health sector through the partnership with Alivira Animal Health Limited. This diversification strategy aims to leverage growth opportunities in the Indian pet healthcare market. Future outlooks would depend on the successful execution of these strategies and the company's ability to adapt to changing market dynamics.

Boehringer Ingelheim India Private Limited has demonstrated a consistent export volume, with a total export value of $772,000 USD and 42 shipments. The concentration of exports in two products suggests a focused approach, which could be advantageous in maintaining quality and supply chain efficiency. However, the lack of product diversification may pose risks if market conditions change. Reliability indicators such as on-time delivery and compliance with international quality standards are not specified in the available sources.

Importers should verify the following certifications to ensure product quality and regulatory compliance:

• FDA Approval: Confirm that the products are approved by the U.S. Food and Drug Administration. Verification can be done through the FDA's official website or by contacting the company directly.

• WHO-GMP: Ensure that the manufacturing facilities comply with World Health Organization Good Manufacturing Practices. This information can be obtained from the WHO's official website or the company's communications.

• EU GMP: Check for compliance with European Union Good Manufacturing Practices. Verification can be done through the European Medicines Agency (EMA) or the company's official communications.

• ISO Certifications: Verify relevant ISO certifications related to quality management systems. These can be confirmed through the International Organization for Standardization's official website or the company's communications.

Importers should undertake the following steps to ensure a thorough evaluation:

• Verify Regulatory Approvals: Confirm that the products have the necessary approvals from relevant regulatory bodies such as the FDA, WHO, and EU authorities.

• Assess Manufacturing Facilities: Evaluate the manufacturing facilities for compliance with international quality standards, including GMP certifications.

• Review Financial Stability: Analyze the company's financial statements to assess stability and capacity to meet supply commitments.

• Check for Compliance with Export Regulations: Ensure that the company complies with export regulations and holds the necessary export No Objection Certificates (NOCs).

• Monitor for Regulatory Actions: Stay informed about any regulatory actions such as warning letters or import alerts that may affect product quality or availability.

By following this checklist, importers can mitigate risks and establish a reliable supply chain with Boehringer Ingelheim India Private Limited.