Shalina Laboratories Private Limited

Shalina Laboratories Private Limited, established on December 13, 1984, is a privately held pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24239MH1984PTC034786. As of the latest available data, Shalina Laboratories has an authorized capital of ₹8.40 crore and a paid-up capital of ₹8.38 crore. The company employs approximately 314 professionals. Its registered office is located at 96 Maker Chamber V, Nariman Point, Mumbai, Maharashtra, 400021.

Shalina Laboratories operates manufacturing facilities in India, specializing in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company exports a diverse portfolio of six products across four therapeutic categories, with a significant focus on Ayurvedic and herbal products. Specific details regarding the locations and capacities of these manufacturing plants are not publicly disclosed.

The leadership team at Shalina Laboratories includes:

• Sundar Sankaran: Director since March 12, 2011.
• Neelam Virji: Director since May 30, 2006.
• Shalina Clifford: Director since February 10, 2015.
• Fazle Abbas Virji: Director since February 10, 2015.
• Sushil Kumar Agarwal: Company Secretary since April 1, 2013.

These individuals play pivotal roles in steering the company's strategic direction and operations.

Shalina Laboratories has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has undertaken regulatory filings and approvals to access these markets, focusing on compliance with international standards. Specific details regarding the number of approved Abbreviated New Drug Applications (ANDAs), Drug Master Files (DMFs), and inspection histories are not publicly disclosed. The company's export data indicates a diversified product portfolio, with significant exports in the Ayurvedic and herbal products category, suggesting a strategic focus on markets with a demand for such products.

Shalina Laboratories has expanded its footprint into emerging markets, particularly in Africa, Latin America, and Southeast Asia. The company's export data highlights a substantial market share in the Ayurvedic and herbal products category, which aligns with the growing demand for natural and traditional medicines in these regions. While specific details regarding WHO prequalification are not publicly available, the company's export activities suggest a strategic approach to penetrating these markets.

Shalina Laboratories demonstrates a diversified geographic strategy, exporting products across multiple regions, including the United States, European Union, United Kingdom, Australia, Japan, Africa, Latin America, and Southeast Asia. This diversification mitigates concentration risk and positions the company to leverage growth opportunities in various markets. The significant export value in Ayurvedic and herbal products indicates a strategic focus on regions with a demand for natural and traditional medicines.

Specific details regarding Shalina Laboratories' FDA facility registrations, approved ANDAs, DMF filings, and inspection history are not publicly disclosed. The company's export data suggests a focus on markets with a demand for Ayurvedic and herbal products, which may influence its regulatory strategies in the United States.

While specific information regarding WHO prequalification and EU Good Manufacturing Practice (GMP) certifications is not publicly available, the company's export activities to regulated markets imply adherence to international quality standards. The significant export value in Ayurvedic and herbal products suggests a strategic focus on markets with a demand for such products, which may require compliance with specific regulatory standards.

Shalina Laboratories holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) and has approvals from state drug controllers. The company has obtained export No Objection Certificates (NOCs) from the Directorate General of Foreign Trade (DGFT), facilitating its international trade activities. Specific details regarding the number of manufacturing licenses, state approvals, and export NOCs are not publicly disclosed.

As of March 28, 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Shalina Laboratories. The company's compliance with regulatory standards in its export markets suggests a proactive approach to maintaining quality and regulatory adherence.

Shalina Laboratories operates in a competitive landscape with several key players in the pharmaceutical industry, particularly in the Ayurvedic and herbal products segment. While specific market share comparisons and head-to-head analyses are not publicly available, the company's significant export value in this category indicates a strong position in the market. The focus on natural products aligns with the growing global demand for alternative and traditional medicines.

Shalina Laboratories' key differentiators include its extensive experience in the pharmaceutical industry, a diversified product portfolio with a strong emphasis on Ayurvedic and herbal products, and a strategic focus on emerging markets with a demand for natural medicines. These strengths position the company to capitalize on global health trends favoring traditional and natural remedies.

Shalina Laboratories is strategically positioned in the generics and specialty pharmaceuticals sectors, with a particular emphasis on Ayurvedic and herbal products. The company's future outlook includes expanding its presence in emerging markets and enhancing its product offerings to meet the evolving needs of global consumers seeking natural and traditional medicines.

Shalina Laboratories has a track record of consistent export volume, with a total export value of $6.2 million USD and 523 shipments across six products in four therapeutic categories. The company's portfolio concentration, with the top five products accounting for 98.8% of exports, indicates a focused approach to product development and market penetration. The significant export value in Ayurvedic and herbal products suggests reliability and demand in this segment.

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

• FDA Registration: Confirm the facility's registration status with the U.S. Food and Drug Administration.
• WHO-GMP Certification: Verify compliance with World Health Organization Good Manufacturing Practices.
• EU GMP Certification: Ensure adherence to European Union Good Manufacturing Practices.
• ISO Certification: Check for relevant International Organization for Standardization certifications.

These certifications can typically be verified through the respective regulatory bodies' official websites or by contacting the company directly.

Importers should undertake the following steps to ensure due diligence:

• Verify Regulatory Certifications: Confirm the validity of FDA, WHO-GMP, EU GMP, and ISO certifications.
• Assess Financial Stability: Review the company's financial statements for indicators of financial health.
• Evaluate Product Quality: Request samples and conduct quality assessments.
• Check Compliance History: Investigate any past regulatory issues or violations.
• Review Supply Chain Practices: Ensure ethical sourcing and manufacturing practices.

Red flags to watch for include expired certifications, unresolved regulatory issues, and inconsistent product quality. Recommended pre-order checks involve obtaining third-party audits and verifying the company's compliance with international standards.