Milan Laboratories (india) Private Limited

Milan Laboratories (India) Private Limited, established on March 26, 2003, is a private pharmaceutical company headquartered in Thane, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24230MH2003PTC139736. It operates as a non-government company limited by shares, with an authorized capital of ₹2.00 crore and a paid-up capital of ₹1.98 crore.

The company specializes in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Over the years, Milan Laboratories has expanded its reach to over 43 countries, holding more than 300 marketing authorizations worldwide.

Milan Laboratories operates WHO-cGMP compliant manufacturing facilities, ensuring adherence to international quality standards. The company's manufacturing plant is located at 303/304, 3rd Floor, Odyssey IT Park, Wagle Estate, MIDC, Thane (W), Maharashtra, India. Specific details regarding the plant's capacities and specializations are not publicly disclosed.

The leadership team of Milan Laboratories comprises:

• Upendra Madan Despande – Director
• Rohini Rajeev Dongre – Director
• Sharwari Upendra Deshpande – Director (appointed on March 13, 2025)
• Rahul Rajeev Dongre – Director (appointed on May 23, 2025)

These directors collectively oversee the strategic direction and operations of the company.

Milan Laboratories has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has achieved over 300 marketing authorizations worldwide, indicating a significant footprint in these regions. While specific regulatory filings and approvals are not publicly detailed, the company's adherence to WHO-cGMP standards suggests compliance with international regulatory requirements.

Milan Laboratories has expanded its reach to over 43 countries, including regions in Africa, Latin America, and Southeast Asia. The company's adherence to WHO-cGMP standards facilitates access to these emerging markets, as WHO prequalification is often a prerequisite for entry.

Milan Laboratories demonstrates a diversified geographic strategy by exporting to over 43 countries across various continents. This broad market presence mitigates concentration risk and positions the company to leverage growth opportunities in both developed and emerging markets. The strategic direction appears focused on expanding global reach while maintaining compliance with international quality standards.

Specific details regarding Milan Laboratories' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available. However, the company's adherence to WHO-cGMP standards suggests a commitment to meeting international regulatory requirements, which is often a prerequisite for FDA approvals.

Milan Laboratories operates WHO-cGMP compliant manufacturing facilities, indicating adherence to international quality standards. While specific certifications such as WHO prequalification or EU GMP certificates are not publicly disclosed, the company's compliance with WHO-cGMP standards suggests a commitment to meeting international regulatory requirements.

Milan Laboratories holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. Specific details regarding state drug controller approvals and export No Objection Certificates (NOCs) are not publicly available. However, the company's adherence to WHO-cGMP standards and its active status with the Ministry of Corporate Affairs indicate compliance with Indian regulatory requirements.

As of March 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Milan Laboratories. The company's adherence to WHO-cGMP standards and its active status with the Ministry of Corporate Affairs suggest a commitment to maintaining regulatory compliance.

Milan Laboratories operates in a competitive pharmaceutical industry, exporting to over 43 countries and holding more than 300 marketing authorizations worldwide. While specific competitors are not identified, the company's adherence to WHO-cGMP standards and its diversified product portfolio position it favorably in the global market.

Milan Laboratories' key differentiators include its adherence to WHO-cGMP standards, a diversified product portfolio encompassing five products across five therapeutic categories, and a significant export value of $4.6 million USD over 166 shipments. These factors contribute to the company's competitive advantage in the pharmaceutical export market.

Milan Laboratories' strategic direction appears focused on expanding its global footprint by exporting to over 43 countries and holding more than 300 marketing authorizations worldwide. The company's adherence to WHO-cGMP standards and its diversified product portfolio suggest a commitment to quality and regulatory compliance. Future outlook may involve further expansion into emerging markets and continuous enhancement of product offerings.

Milan Laboratories has demonstrated a consistent track record in pharmaceutical exports, with a total export value of $4.6 million USD over 166 shipments. The company's adherence to WHO-cGMP standards and its diversified product portfolio indicate reliability and a commitment to quality. However, specific indicators of reliability, such as customer feedback or third-party audits, are not publicly available.

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

• WHO-GMP Certification: To confirm adherence to international manufacturing standards.
• EU GMP Certification: To ensure compliance with European Union manufacturing standards.
• ISO Certification: To verify quality management systems.

These certifications can typically be verified through the company's official website or by contacting the relevant regulatory bodies.

When conducting due diligence on Milan Laboratories, consider the following steps:

• Verify Certifications: Confirm WHO-GMP, EU GMP, and ISO certifications.
• Review Regulatory Compliance: Check for any recent regulatory actions or compliance issues.
• Assess Financial Health: Review financial statements and credit reports.
• Evaluate Product Quality: Request product samples and conduct quality assessments.
• Check References: Obtain feedback from existing customers or partners.

Be cautious of any discrepancies in certification or regulatory compliance records, as these may indicate potential risks.