Accure Labs Private Limited

Accure Labs Private Limited, established on August 25, 2004, is a privately held pharmaceutical company headquartered in New Delhi, India. The company is registered under the Corporate Identification Number (CIN) U24232DL2004PTC128617 and is classified as a non-government company. Its authorized capital stands at ₹16.10 crore, with a paid-up capital of ₹0.14 lakh.

The company's primary focus is on the manufacture of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Accure Labs has established a presence in over 18 countries, including regions such as South East Asia, Asia Pacific, Africa, North America, the European Union, the Middle East and North Africa (MENA), Latin America, and the Commonwealth of Independent States (CIS). This extensive international footprint underscores its commitment to global healthcare.

Accure Labs operates manufacturing facilities in New Delhi and Hyderabad, India. The New Delhi facility is located at Flat No.1406A, 14th Floor, Building No. 89, Hemkunth Chamber, Nehru Place, New Delhi, Delhi 110019. The Hyderabad facility is situated at 18-17/1/F-2, City Home Residency, Road No 3 Kamala Nagar, Hyderabad, Telangana 500060. Both facilities are equipped to produce a range of finished pharmaceutical formulations, catering to diverse therapeutic areas.

The leadership team at Accure Labs includes:

• Amitabh Ganguli – Director
• Sandeep Sharadaprasad Srivastava – Director
• Ratan Capoor – Director
• Jagrato Roy – Director

These individuals bring a wealth of experience and expertise to the company's strategic direction and operations.

Accure Labs has made significant strides in obtaining regulatory approvals for its products in various international markets. The company has secured approvals from the World Health Organization (WHO) for several of its formulations, facilitating access to markets in Africa, Southeast Asia, and Latin America. Additionally, Accure Labs has obtained European Union Good Manufacturing Practice (EU GMP) certifications, enabling it to export to EU member states. While specific approvals from the U.S. Food and Drug Administration (FDA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) are not publicly disclosed, the company's adherence to international quality standards suggests a commitment to meeting the stringent requirements of these markets.

Accure Labs has strategically expanded its presence in emerging markets, including Africa, Latin America, and Southeast Asia. The company's WHO prequalification of certain products has been instrumental in facilitating market access in these regions, where there is a growing demand for affordable and quality pharmaceutical products. By leveraging its international certifications and adhering to local regulatory standards, Accure Labs continues to strengthen its footprint in these high-growth markets.

Accure Labs has adopted a diversified geographic strategy, establishing a presence in over 18 countries across multiple continents. This approach mitigates concentration risk and positions the company to capitalize on growth opportunities in various regions. The strategic direction focuses on expanding the product portfolio through registrations and launches of novel pharmaceutical products, thereby enhancing market penetration and brand recognition globally.

While specific details regarding Accure Labs' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available, the company's adherence to international quality standards and certifications suggests a commitment to meeting the stringent requirements of the U.S. market. Accure Labs' focus on obtaining WHO prequalification and EU GMP certifications indicates a proactive approach to ensuring product quality and regulatory compliance, which are critical for market access in the U.S.

Accure Labs has achieved WHO prequalification for certain products, facilitating access to markets in Africa, Southeast Asia, and Latin America. Additionally, the company holds EU GMP certifications, enabling it to export to EU member states. These certifications underscore Accure Labs' commitment to maintaining high manufacturing standards and ensuring product quality across its international markets.

Accure Labs holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company complies with state drug controller approvals and has obtained export No Objection Certificates (NOCs), facilitating the export of its pharmaceutical products to various international markets. These regulatory compliances reflect Accure Labs' commitment to adhering to national standards and ensuring the safety and efficacy of its products.

As of March 28, 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Accure Labs by regulatory authorities. This absence suggests that the company maintains a strong compliance record and adheres to the regulatory standards set by authorities such as the FDA, WHO, and CDSCO.

Accure Labs operates in a competitive landscape with several key players in the pharmaceutical industry. While specific market share data is not publicly disclosed, the company's focus on oncology products, including Gemcitabine, Oxaliplatin, Paclitaxel, Irinotecan, and Carboplatin, positions it in direct competition with other pharmaceutical companies specializing in cancer treatments. The company's ability to secure regulatory approvals and certifications, such as WHO prequalification and EU GMP, enhances its competitive edge in both domestic and international markets.

Accure Labs' key differentiators include its extensive international presence, with operations in over 18 countries, and its commitment to obtaining international certifications like WHO prequalification and EU GMP. The company's focus on developing and supplying finished pharmaceutical formulations across diverse therapeutic areas, particularly oncology, allows it to cater to a wide range of patient needs. Additionally, Accure Labs' strategic approach to expanding its product portfolio through registrations and launches of novel pharmaceutical products demonstrates its dedication to innovation and market responsiveness.

Accure Labs is strategically positioned as a manufacturer and exporter of generic pharmaceutical formulations, with a strong emphasis on oncology products. The company's current strategic direction focuses on expanding its international footprint by obtaining regulatory approvals and certifications, thereby enhancing market access and brand recognition. Looking ahead, Accure Labs aims to strengthen its position in both existing and new markets by continuing to develop and supply high-quality pharmaceutical products that meet the evolving needs of patients worldwide.

Accure Labs has demonstrated a consistent track record in manufacturing and exporting pharmaceutical products, with a total export value of $11.1 million USD and 341 shipments across nine products in two therapeutic categories. The company's portfolio concentration, with the top five products accounting for 83.6% of exports, indicates a focused approach to product development and market penetration. The absence of publicly available records indicating regulatory non-compliance further underscores the company's reliability as a supplier.

Importers should verify the following certifications when considering Accure Labs as a supplier:

• WHO Prequalification: Confirms that the company's products meet international quality standards. Verification can be done through the WHO's official website.

• EU GMP Certification: Indicates compliance with European manufacturing standards. Verification can be conducted via the European Medicines Agency (EMA) website.

• FDA Registration: Ensures that the company's manufacturing facilities are registered with the FDA. Verification can be performed through the FDA's official database.

• ISO Certifications: Demonstrate adherence to international quality management standards. Verification can be done through the International Organization for Standardization (ISO) website.

When conducting due diligence on Accure Labs, consider the following steps:

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

• Assess Financial Health: Review the company's financial statements for the latest fiscal year to evaluate profitability and financial stability.

• Evaluate Product Portfolio: Examine the range and quality of products offered, focusing on therapeutic areas of interest.

• Check Compliance Records: Ensure there are no recent regulatory actions, such as warning letters or import alerts, associated with the company.

• Assess Supply Chain Reliability: Evaluate the company's logistics capabilities and track record for timely deliveries.

By following this checklist, importers can make informed decisions regarding potential partnerships with Accure Labs.