Mylan Pharmaceuticals Private Limited

Mylan Pharmaceuticals Private Limited, established on March 3, 1997, is a private limited company headquartered in Hyderabad, Telangana, India. The company is registered under the Corporate Identification Number (CIN) U73100TG1997PTC149781. It operates as a subsidiary of Viatris, a global pharmaceutical company formed in November 2020 through the merger of Mylan N.V. and Upjohn, Pfizer's off-patent medicine division.

The authorized capital of Mylan Pharmaceuticals Private Limited is ₹120.00 crore, with a paid-up capital of ₹10.00 crore. As of July 18, 2025, the company employed approximately 3,092 professionals. The registered office is located at Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096.

Mylan Pharmaceuticals Private Limited operates manufacturing facilities in India, including a plant in Nashik, Maharashtra, which produces finished-dosage-form antiretroviral (ARV) products. This facility has been subject to Good Manufacturing Practices (GMP) inspections by several leading regulatory authorities, including the U.S. Food and Drug Administration (FDA). Additionally, the company has a manufacturing plant located at Plot No. 1-A/2, MIDC, Industrial Area, Taloja, Panvel Raigarh, Maharashtra, 410208.

As of July 18, 2025, the key leadership at Mylan Pharmaceuticals Private Limited includes:

• Praveen Singh Chauhan – Whole-Time Director, appointed on April 16, 2024.

• Ajay Singh Rathore – Whole-Time Director, appointed on June 21, 2019.

• Rekha Lakhotiya – Company Secretary, appointed on December 3, 2015.

These leaders are responsible for overseeing the company's operations and strategic direction.

Mylan Pharmaceuticals Private Limited has a significant presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facilities, such as the one in Nashik, Maharashtra, have been inspected and approved by the U.S. FDA, ensuring compliance with stringent regulatory standards. Additionally, Mylan has received marketing authorization from the Drug Controller General of India (DCGI) for various products, including antiretroviral drugs like Avonza™ (TLE400), a fixed-dose combination for HIV/AIDS treatment. These approvals facilitate the company's market access and distribution in these regions.

Mylan Pharmaceuticals Private Limited has expanded its footprint in emerging markets, particularly in Africa, Latin America, and Southeast Asia. The company's partnership with Gilead Sciences to distribute Sovaldi® and Harvoni® in India exemplifies its commitment to addressing public health challenges in these regions. Furthermore, Mylan's manufacturing facilities have been subject to inspections by the World Health Organization (WHO), ensuring compliance with international standards and facilitating access to these markets.

Mylan Pharmaceuticals Private Limited's geographic strategy demonstrates a focus on both developed and emerging markets. The company's presence in regulated markets like the U.S., EU, UK, Australia, and Japan indicates a commitment to maintaining high-quality standards and accessing established pharmaceutical markets. Simultaneously, its expansion into emerging markets, including Africa, Latin America, and Southeast Asia, reflects a strategic approach to tap into growing healthcare needs and increasing demand for affordable medicines. This diversified geographic presence helps mitigate concentration risks and positions the company for sustainable growth.

Mylan Pharmaceuticals Private Limited's manufacturing facilities, such as the one in Nashik, Maharashtra, have been inspected and approved by the U.S. FDA. This approval ensures that the company's products meet the stringent quality standards required for the U.S. market. Additionally, the company's manufacturing plant located at Plot No. 1-A/2, MIDC, Industrial Area, Taloja, Panvel Raigarh, Maharashtra, 410208, is registered with the FDA, indicating compliance with U.S. regulatory requirements.

Mylan Pharmaceuticals Private Limited's manufacturing facilities have been subject to inspections by the World Health Organization (WHO), ensuring compliance with international Good Manufacturing Practices (GMP). This compliance facilitates the company's access to global markets and underscores its commitment to maintaining high-quality standards. Additionally, the company's manufacturing plant located at Plot No. 1-A/2, MIDC, Industrial Area, Taloja, Panvel Raigarh, Maharashtra, 410208, is registered with the European Medicines Agency (EMA), indicating adherence to EU GMP standards.

Mylan Pharmaceuticals Private Limited holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company's manufacturing facilities, including the one in Nashik, Maharashtra, have been inspected and approved by the CDSCO, ensuring compliance with Indian regulatory standards. Additionally, the company's manufacturing plant located at Plot No. 1-A/2, MIDC, Industrial Area, Taloja, Panvel Raigarh, Maharashtra, 410208, is registered with the Maharashtra State Food and Drug Administration (FDA), indicating adherence to state-level regulatory requirements.

As of March 28, 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Mylan Pharmaceuticals Private Limited by the U.S. FDA or other regulatory authorities. This absence suggests that the company's manufacturing facilities are in good standing with regulatory bodies. However, it is advisable for stakeholders to consult the latest regulatory databases and official communications for the most current information.

Mylan Pharmaceuticals Private Limited operates in a competitive landscape, particularly in the oncology and antiretroviral (ARV) segments. In the oncology segment, the company exports Bevacizumab and Trastuzumab, with export values of $650K and $250K, respectively. These products hold market shares of 1.4% and 0.3%, ranking 7th and 11th in their respective categories. The company's portfolio concentration is high, with the top five products accounting for 100% of its exports. This indicates a focused approach but also exposes the company to risks associated with over-reliance on a limited product range.

Mylan Pharmaceuticals Private Limited's key differentiators include its strong presence in the oncology and ARV segments, with a focused product portfolio that allows for specialized expertise and operational efficiencies. The company's compliance with international regulatory standards, such as WHO GMP and EU GMP, enhances its credibility and facilitates access to global markets. Additionally, its strategic partnerships, such as the exclusive agreement with Gilead Sciences to distribute Sovaldi® and Harvoni® in India, demonstrate its commitment to addressing significant public health challenges.

Mylan Pharmaceuticals Private Limited's current strategic direction focuses on the oncology and ARV segments, with a high portfolio concentration in these areas. The company's adherence to international regulatory standards and strategic partnerships position it well for future growth. However, the high portfolio concentration suggests a need for diversification to mitigate risks associated with over-reliance on a limited product range. Future strategies may include expanding into additional therapeutic areas and enhancing its presence in emerging markets to leverage growth opportunities.

Mylan Pharmaceuticals Private Limited has a track record of exporting finished pharmaceutical formulations, with a total export value of $900K USD across 18 shipments. The company's focus on oncology and ARV products, with a high portfolio concentration, indicates specialized expertise and operational efficiencies. The absence of publicly available records indicating regulatory issues, such as Form 483 observations or warning letters, suggests reliability in its manufacturing processes. However, the high portfolio concentration may pose risks related to market fluctuations and regulatory changes affecting specific product categories.

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

• FDA