SP Accure Labs Private Limited

SP Accure Labs Private Limited, established on September 30, 2013, is a private pharmaceutical company headquartered in Hyderabad, Telangana, India. The company is registered under the Corporate Identification Number (CIN) U24232TG2013PTC090271. As of the latest available data, SP Accure Labs has an authorized capital of ₹18.00 crore and a paid-up capital of ₹17.64 crore. The company is unlisted and operates in the manufacturing sector, focusing on pharmaceutical products.

The company's registered office is located at 18-17/1/F-2, City Home Residency, Road No 3 Kamala Nagar, Hyderabad, Telangana, 500060, India. SP Accure Labs specializes in the innovation and manufacturing of high-quality oncology and anticancer drugs, offering a comprehensive portfolio of oral and injectable cancer medications.

SP Accure Labs operates state-of-the-art manufacturing facilities in Hyderabad, Telangana, India. These facilities are designed to produce a wide range of oncology formulations, including both oral solid dosage forms and injectable products. The company emphasizes compliance with international quality standards, ensuring the production of high-quality pharmaceutical products.

The leadership team at SP Accure Labs includes:

• Vijayaprakash Katikala: Director

• Manikya Swarna Latha Kodali: Director

These individuals have been instrumental in steering the company's strategic direction and growth.

SP Accure Labs has established a significant presence in several regulated markets, including the United Kingdom, Europe, Canada, and South Korea. The company has obtained certifications from global regulatory bodies such as the European Medicines Agency (EMA), Canada Health GMP, and Malaysia GMP, validating its commitment to quality and safety.

SP Accure Labs actively participates in international tenders with organizations like UNGM, UNOPS, and UNICEF, contributing to advancements in cancer treatment. This engagement facilitates access to emerging markets, particularly in Africa, Latin America, and Southeast Asia. The company's adherence to international quality standards, as evidenced by its certifications, enhances its ability to penetrate these markets.

SP Accure Labs demonstrates a diversified geographic strategy by establishing a strong foothold in both regulated and emerging markets. This approach mitigates concentration risk and positions the company for sustainable growth across various regions. The strategic direction focuses on expanding market access while maintaining high-quality standards.

As of the latest available data, specific details regarding SP Accure Labs' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly disclosed. The company has not been subject to any FDA Form 483 observations, warning letters, or import alerts. This suggests a favorable compliance record with the FDA.

SP Accure Labs holds certifications from the European Medicines Agency (EMA), Canada Health GMP, and Malaysia GMP, indicating compliance with international Good Manufacturing Practices (GMP) standards. These certifications validate the company's commitment to producing high-quality pharmaceutical products.

SP Accure Labs operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company holds manufacturing licenses and approvals from state drug controllers, ensuring compliance with Indian pharmaceutical regulations. Specific details regarding export No Objection Certificates (NOCs) are not publicly disclosed.

As of the latest available data, SP Accure Labs has not been subject to any regulatory actions such as Form 483 observations, warning letters, or import alerts from the FDA, WHO, EU, CDSCO, or other regulatory bodies. This indicates a favorable compliance record across various jurisdictions.

SP Accure Labs operates in the competitive oncology pharmaceutical sector, facing competition from both domestic and international companies. While specific competitors are not identified in the available data, the company's focus on high-quality oncology formulations and adherence to international standards position it favorably in the market.

SP Accure Labs' key differentiators include its specialization in oncology generics, offering an extensive portfolio of oral and injectable cancer medications. The company's commitment to quality is validated by certifications from global regulatory bodies such as the EMA, Canada Health GMP, and Malaysia GMP. Additionally, SP Accure Labs actively participates in international tenders with organizations like UNGM, UNOPS, and UNICEF, contributing to advancements in cancer treatment.

SP Accure Labs is strategically positioned as a manufacturer of oncology generics, focusing on both oral and injectable formulations. The company's adherence to international quality standards and active participation in global tenders underscore its commitment to expanding its market presence. The future outlook appears positive, with opportunities for growth in both regulated and emerging markets.

SP Accure Labs has demonstrated a consistent track record in manufacturing high-quality oncology formulations. The company's export volume and consistency are supported by certifications from global regulatory bodies, indicating reliability in meeting international standards. While specific export volumes are not detailed, the company's active participation in international tenders suggests a robust export performance.

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

• FDA Approval: Confirm the FDA approval status of specific products by checking the FDA's Orange Book or contacting the FDA directly.

• WHO-GMP: Verify WHO-GMP certification through the World Health Organization's official website or by contacting the organization.

• EU GMP: Check for EU GMP certification by consulting the European Medicines Agency's official website or contacting the agency.

• ISO Certification: Request ISO certification details from SP Accure Labs and verify them through the International Organization for Standardization's official website.

Importers should undertake the following steps to ensure due diligence:

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

• Assess Compliance Records: Review any available records of regulatory inspections, observations, or actions taken against the company.

• Evaluate Financial Stability: Analyze the company's financial statements to assess its financial health and stability.

• Inspect Manufacturing Facilities: If possible, conduct site visits to evaluate the manufacturing facilities' compliance with quality standards.

• Review Product Portfolio: Examine the product portfolio to ensure it meets the specific needs and quality expectations.

By following this checklist, importers can make informed decisions and establish reliable partnerships with SP Accure Labs.