Unicure Remedies Private Limited

Unicure Remedies Private Limited, established on March 3, 1993, is a privately held pharmaceutical company headquartered in Vadodara, Gujarat, 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 U24230GJ1993PTC019076. As of the latest available data, Unicure Remedies has an authorized capital of ₹4.50 crore and a paid-up capital of ₹2.48 crore. The company employs approximately 351 professionals. The registered office is located at F/25, B I D C Industrial Estate, Gorwa, Vadodara, Gujarat, 390016.

Unicure Remedies operates a manufacturing facility situated in the B I D C Industrial Estate in Vadodara, Gujarat. The plant specializes in the production of various pharmaceutical formulations, including tablets, capsules, syrups, and injections. While specific production capacities are not publicly disclosed, the facility is designed to meet both domestic and international market demands. The company emphasizes adherence to international quality standards, ensuring the production of high-quality pharmaceutical products.

The leadership team at Unicure Remedies Private Limited includes:

• Virag Parimal Divanji: Director since March 3, 1993.

• Jayurbhai Ramanbhai Patel: Director since March 14, 2013.

• Rahul Mansukhbhai Desai: Chief Financial Officer (CFO) since April 1, 2023.

Unicure Remedies Private Limited has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company exports a range of pharmaceutical formulations, such as Spironolactone, Digoxin, Azathioprine, and Warfarin, across these regions. Specific regulatory filings, approvals, and market access statuses are not publicly disclosed. However, the company's adherence to international quality standards suggests compliance with the regulatory requirements of these markets.

Unicure Remedies Private Limited has expanded its reach to emerging markets in Africa, Latin America, and Southeast Asia. The company's export portfolio includes formulations such as Spironolactone, Digoxin, Azathioprine, and Warfarin, catering to the therapeutic needs of these regions. While specific details regarding WHO prequalification are not publicly available, the company's commitment to quality and compliance with international standards likely facilitates access to these markets.

Unicure Remedies Private Limited demonstrates a diversified geographic strategy by exporting its pharmaceutical formulations to various international markets, including the United States, European Union, United Kingdom, Australia, Japan, Africa, Latin America, and Southeast Asia. This approach mitigates concentration risk and positions the company to leverage growth opportunities across different regions. The strategic direction appears to focus on expanding market presence and catering to diverse therapeutic needs globally.

Specific details regarding Unicure Remedies Private Limited's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly disclosed. However, the company's export activities to regulated markets, including the United States, suggest compliance with FDA regulations and standards. The absence of publicly available information on FDA approvals indicates that the company may not have received FDA approvals for its products.

Unicure Remedies Private Limited's manufacturing facility is WHO Good Manufacturing Practice (GMP) approved, indicating adherence to international quality standards. Specific details regarding EU GMP certificates and European Directorate for the Quality of Medicines & HealthCare (EDQM) status are not publicly available. The company's commitment to quality and compliance with international standards suggests a focus on meeting the requirements of various regulatory bodies.

Unicure Remedies Private Limited holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. Specific details regarding state drug controller approvals and export No Objection Certificates (NOCs) are not publicly disclosed. The company's adherence to CDSCO regulations indicates compliance with Indian pharmaceutical manufacturing standards.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Unicure Remedies Private Limited. The absence of such records suggests that the company maintains a compliant status with regulatory authorities.

Unicure Remedies Private Limited operates in a competitive pharmaceutical industry, with key competitors in overlapping categories such as diuretics, cardiovascular, and immunosuppressants. While specific market share comparisons are not publicly available, the company's export value of $692,000 USD and a portfolio concentration of 100% in its top five products indicate a focused approach. The company's emphasis on quality and adherence to international standards positions it to compete effectively in the global market.

Unicure Remedies Private Limited's key differentiators include its focus on quality excellence, adherence to international standards, and a diversified product portfolio. The company's manufacturing facility is WHO GMP approved, reflecting its commitment to maintaining high-quality production processes. Additionally, the company's export activities to various international markets demonstrate its ability to meet diverse therapeutic needs globally.

Unicure Remedies Private Limited's current strategic direction focuses on the export of finished pharmaceutical formulations, including diuretics, cardiovascular drugs, and immunosuppressants. The company's adherence to international quality standards and its WHO GMP approved facility suggest a commitment to maintaining high-quality production processes. The future outlook appears to involve expanding market presence and catering to diverse therapeutic needs globally.

Unicure Remedies Private Limited has a track record of exporting pharmaceutical formulations to various international markets, including the United States, European Union, United Kingdom, Australia, Japan, Africa, Latin America, and Southeast Asia. The company's export value of $692,000 USD and a portfolio concentration of 100% in its top five products indicate a focused approach. The absence of publicly available records of regulatory actions suggests reliability in its operations. The company's adherence to international quality standards, as evidenced by its WHO GMP approved facility, further indicates its commitment to maintaining high-quality production processes.

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

• FDA Approval: Confirm the FDA approval status of specific products by checking the FDA's official database or contacting the manufacturer directly.

• WHO GMP Certification: Verify the WHO GMP certification by requesting a copy of the certificate from the manufacturer or checking the WHO's official list of certified manufacturers.

• EU GMP Certification: Confirm the EU GMP certification by requesting a copy of the certificate from the manufacturer or checking the European Medicines Agency's (EMA) official list of certified manufacturers.

• ISO Certification: Verify ISO certifications by requesting copies of the certificates from the manufacturer or checking the International Organization for Standardization's (ISO) official database.

Importers should undertake the following steps to ensure a thorough evaluation of Unicure Remedies Private Limited:

• Verify Regulatory Approvals: Confirm the FDA approval status of specific products and ensure compliance with relevant regulations.

• Assess Manufacturing Facilities: Evaluate the WHO GMP certification and inspect the manufacturing facility for adherence to quality standards.

• Review Financial Stability: Analyze the company's financial statements to assess profitability, revenue growth, and overall financial health.

• Check for Regulatory Actions: Investigate any past or current regulatory actions, such as warning letters or import alerts, to assess compliance history.

• Evaluate Product Quality: Request product samples and conduct quality testing to ensure they meet required standards.

• Assess Supply Chain Reliability: Evaluate the company's logistics capabilities and