Sandoz Private Limited

Sandoz Private Limited, incorporated on March 30, 1995, is a private limited company based in Maharashtra, India. Its Corporate Identification Number (CIN) is U24230MH1995PTC086989, and it is registered under the Registrar of Companies, Mumbai. The company specializes in the manufacturing of pharmaceuticals, medicinal chemicals, and botanical products.

The registered office is located at Kalwe MIDC, Plot No. 8-A/2, 8/B, TTC Industrial Area, Kalwe Block, Village Dighe, Navi Mumbai, Maharashtra 400708, India. Sandoz Private Limited operates as a non-government company limited by shares, with an authorized capital of ₹50,000,000 and a paid-up capital of ₹32,000,000.

Sandoz Private Limited's manufacturing facility is situated in Navi Mumbai, Maharashtra. The plant specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Specific details regarding production capacities and additional manufacturing sites are not publicly disclosed.

As of March 2026, the board of directors of Sandoz Private Limited includes:

• Sudhir Trambakrao Bhandare
• Sanjeev Shrivastav
• Rajeev Ranjan
• Nishith Laxmikant Vaidya

The company does not publicly disclose the specific roles of these directors.

Sandoz Private Limited exports finished pharmaceutical formulations to various international markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has secured regulatory approvals for its products in these regions, facilitating market access. Specific details regarding individual product approvals and regulatory filings are not publicly disclosed.

Sandoz Private Limited has expanded its presence in emerging markets across Africa, Latin America, and Southeast Asia. The company has obtained WHO prequalification for certain products, enabling access to these regions. Specific details regarding product approvals and market penetration strategies are not publicly disclosed.

Sandoz Private Limited demonstrates a diversified geographic strategy by exporting to both developed and emerging markets. This approach mitigates concentration risk and aligns with the company's strategic direction to enhance global market presence.

Sandoz Private Limited's manufacturing facility is registered with the U.S. Food and Drug Administration (FDA). The company has filed Abbreviated New Drug Applications (ANDAs) for various products, and its Drug Master Files (DMFs) are accessible to the FDA. Specific details regarding inspection history and individual product approvals are not publicly disclosed.

Sandoz Private Limited has obtained WHO prequalification for certain products, ensuring compliance with international quality standards. The company also holds EU Good Manufacturing Practice (GMP) certificates, affirming adherence to European manufacturing standards. Specific details regarding individual product certifications are not publicly disclosed.

Sandoz Private Limited holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) and has obtained approvals from state drug controllers. The company has received export No Objection Certificates (NOCs) from the Directorate General of Foreign Trade (DGFT), facilitating international trade. Specific details regarding individual product approvals and regulatory compliance are not publicly disclosed.

As of March 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Sandoz Private Limited by regulatory authorities.

Sandoz Private Limited operates in a competitive landscape, with several multinational and domestic pharmaceutical companies offering similar products. The company's market share varies across different therapeutic categories, with notable positions in immunosuppressants, CNS & psychiatric, and cardiovascular segments. Specific market share comparisons and head-to-head analyses are not publicly disclosed.

Sandoz Private Limited's key differentiators include its diversified product portfolio, strong presence in multiple therapeutic categories, and adherence to international quality standards. The company's ability to secure regulatory approvals across various markets enhances its competitive advantage.

Sandoz Private Limited's current strategic direction focuses on the production and export of generic pharmaceutical formulations. The company's future outlook includes potential expansion into specialty drugs and biosimilars, leveraging its manufacturing capabilities and regulatory expertise.

Sandoz Private Limited has a strong track record in pharmaceutical manufacturing, with consistent export volumes and adherence to international quality standards. The company's reliability is indicated by its regulatory approvals and certifications from authorities such as the FDA, WHO, and EU GMP.

Importers should verify the following certifications when considering Sandoz Private Limited as a supplier:

• FDA Registration: Confirm the company's registration status and product approvals through the FDA's official database.

• WHO-GMP Certification: Obtain copies of WHO prequalification certificates for relevant products.

• EU GMP Certification: Request EU GMP certificates for applicable products.

• ISO Certifications: Verify ISO certifications related to quality management systems.

When conducting due diligence on Sandoz Private Limited, consider the following steps:

• Verify Regulatory Approvals: Confirm product approvals and certifications from relevant authorities.

• Assess Financial Stability: Review the company's financial statements and credit history.

• Evaluate Manufacturing Capabilities: Inspect manufacturing facilities for compliance with quality standards.

• Check Compliance Records: Review any past regulatory actions or compliance issues.

• Assess Supply Chain Reliability: Evaluate the consistency and reliability of the company's supply chain.

Red flags to watch for include unresolved regulatory issues, financial instability, and discrepancies in product certifications.

Recommended pre-order checks involve obtaining samples for quality assessment, verifying shipping and delivery terms, and ensuring clear communication regarding product specifications and compliance requirements.