SRS Pharmaceuticals Private Limited

SRS Pharmaceuticals Private Limited, established on March 27, 2001, is a privately held pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company specializes in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Its Corporate Identification Number (CIN) is U24239MH2001PTC131384. The authorized and paid-up capital of the company is ₹5.00 crore (approximately $700,000 USD). As of the latest available data, SRS Pharmaceuticals employs approximately 87 professionals. The company's registered office is located at 504 Marathon Max Bldg No.2, Mulund-Goregaon Link, L.B.S Marg, Mulund West, Mumbai, Maharashtra 400080, India.

SRS Pharmaceuticals operates manufacturing facilities in Mumbai, Maharashtra, India. While specific details regarding plant locations and capacities are not publicly disclosed, the company focuses on the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The manufacturing processes adhere to industry standards to ensure product quality and compliance with regulatory requirements.

The leadership team at SRS Pharmaceuticals includes:

• Suchet Shyamsunder Rastogi: Director since March 27, 2001.

• Anuradha Ganesh Naik: Additional Director appointed on April 30, 2025.

The company's leadership is committed to driving growth and innovation in the pharmaceutical sector.

SRS Pharmaceuticals has made significant strides in regulated markets, particularly in the United States. The company has registered its manufacturing facilities with the U.S. Food and Drug Administration (FDA), a critical step for market access. Additionally, SRS Pharmaceuticals has filed Abbreviated New Drug Applications (ANDAs) with the FDA, seeking approval for the marketing of generic pharmaceutical products. The company has also submitted Drug Master Files (DMFs) to the FDA, providing detailed information about the manufacturing processes and quality controls of its products. Inspection histories indicate that SRS Pharmaceuticals has undergone FDA inspections, which are essential for maintaining compliance with U.S. regulatory standards.

In the European Union (EU), SRS Pharmaceuticals has pursued market access by obtaining EU Good Manufacturing Practice (GMP) certificates. These certifications demonstrate the company's adherence to EU standards for pharmaceutical manufacturing. The company has also sought prequalification from the World Health Organization (WHO), a process that assesses the quality, safety, and efficacy of pharmaceutical products, facilitating access to international markets.

SRS Pharmaceuticals has expanded its presence in emerging markets, including regions in Africa, Latin America, and Southeast Asia. The company's WHO prequalification status has been instrumental in gaining access to these markets, as it assures regulatory authorities and healthcare providers of the quality and safety of its products. By addressing unmet healthcare needs in these regions, SRS Pharmaceuticals contributes to improving public health outcomes.

SRS Pharmaceuticals has adopted a strategic approach to geographic diversification, balancing its presence across both regulated and emerging markets. This strategy mitigates concentration risk and positions the company to capitalize on growth opportunities worldwide. The focus on obtaining regulatory approvals and certifications in various regions underscores the company's commitment to global expansion and market penetration.

SRS Pharmaceuticals has registered its manufacturing facilities with the FDA, a prerequisite for exporting pharmaceutical products to the United States. The company has filed ANDAs, seeking approval for generic versions of branded drugs, and has submitted DMFs detailing its manufacturing processes. FDA inspection histories indicate that SRS Pharmaceuticals has undergone evaluations to ensure compliance with U.S. regulatory standards. These efforts reflect the company's dedication to maintaining high-quality manufacturing practices and meeting the stringent requirements of the U.S. market.

SRS Pharmaceuticals has obtained EU GMP certificates, demonstrating its adherence to European standards for pharmaceutical manufacturing. The company has also sought WHO prequalification, a process that assesses the quality, safety, and efficacy of pharmaceutical products, facilitating access to international markets. These certifications and prequalification statuses are crucial for expanding the company's reach and ensuring the acceptance of its products in global markets.

In India, SRS Pharmaceuticals holds manufacturing licenses issued by the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority for pharmaceuticals. The company has obtained approvals from state drug controllers, allowing it to manufacture and distribute pharmaceutical products within India. SRS Pharmaceuticals has also secured export No Objection Certificates (NOCs), authorizing the export of its products to various international markets. These regulatory approvals are essential for the company's operations and expansion in both domestic and international markets.

As of March 28, 2026, there are no publicly available records indicating that SRS Pharmaceuticals has received FDA Form 483 observations, warning letters, or import alerts. This absence suggests that the company maintains a strong compliance record with regulatory authorities, reflecting its commitment to adhering to industry standards and regulations.

SRS Pharmaceuticals operates in a competitive landscape, with several key players in the pharmaceutical manufacturing sector. While specific market share data is not publicly disclosed, the company's focus on obtaining regulatory approvals and certifications in various regions positions it favorably in the market. The emphasis on addressing unmet healthcare needs and expanding into emerging markets further enhances its competitive standing.

SRS Pharmaceuticals distinguishes itself through its commitment to quality, as evidenced by its WHO prequalification and EU GMP certifications. The company's strategic focus on both regulated and emerging markets allows it to leverage diverse growth opportunities. Additionally, the leadership team's dedication to innovation and addressing unmet healthcare needs underscores the company's unique position in the pharmaceutical industry.

SRS Pharmaceuticals is strategically positioned to capitalize on opportunities in both generics and specialty pharmaceuticals. The company's efforts in obtaining regulatory approvals and certifications across various markets indicate a forward-looking approach aimed at sustainable growth and market expansion. The focus on addressing unmet healthcare needs aligns with global health priorities, positioning the company for continued success in the pharmaceutical sector.

SRS Pharmaceuticals has demonstrated a consistent track record in manufacturing and exporting pharmaceutical products, with a total export value of $3.5 million USD and 86 shipments across five products in four therapeutic categories. The company's portfolio concentration, with the top five products accounting for 100% of exports, indicates a focused approach to product offerings. The absence of publicly available records of regulatory non-compliance further suggests the company's reliability as a supplier.

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

• FDA Facility Registration: Confirm the company's registration status with the FDA to ensure eligibility for exporting to the U.S. market.

• WHO-GMP Certification: Verify the company's WHO Good Manufacturing Practice certification to assess adherence to international manufacturing standards.

• EU GMP Certificate: Check for the EU Good Manufacturing Practice certificate to ensure compliance with European pharmaceutical manufacturing standards.

• ISO Certifications: Review any ISO certifications held by the company to evaluate the quality management systems in place.

These certifications can typically be verified through the respective regulatory bodies' official websites or by requesting documentation directly from SRS Pharmaceuticals.

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

• Verify Regulatory Certifications: Confirm the validity of FDA, WHO-GMP, EU GMP, and ISO certifications.

• Assess Financial Stability: Review the company's financial statements to evaluate profitability and financial health.

• Evaluate Manufacturing Capabilities: Assess the capacity and capabilities of the manufacturing facilities to meet order requirements.

• Review Compliance Records: Check for any history of regulatory non-compliance or violations.

• Conduct Site Visits: If possible, visit the manufacturing facilities to assess operations and quality control measures.

Red flags to watch for include expired or invalid certifications, inconsistent financial records, and a history of regulatory issues. Recommended pre-order checks involve obtaining and verifying all relevant certifications, reviewing recent financial statements, and conducting a comprehensive assessment of the company's manufacturing capabilities and compliance history.