Prashi Pharma Private Limited

Prashi Pharma Private Limited, established on December 23, 1998, is a privately held pharmaceutical company based in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24234MH1998PTC117590. As of the latest available data, Prashi Pharma has an authorized capital of ₹10 million and a paid-up capital of ₹9.9 million.

The company's registered office is located at 503, 5th Floor, Surya House, Shree Golvalkar Guruji Marg, Road No. 7, Near Vidyavihar Station, Vidyavihar East, Mumbai, Maharashtra, 400077, India. Prashi Pharma specializes in the manufacturing of pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company has a significant production capacity, with the ability to manufacture approximately 200 million tablets, 20 million capsules, and 1 million bottles of syrups per month.

Prashi Pharma operates a manufacturing facility located in Shirgaon, Palghar, Maharashtra. This plant is equipped with high-capacity production lines capable of producing 200 million tablets, 20 million capsules, and 1 million bottles of syrups monthly. The facility specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company is in the process of obtaining WHO Good Manufacturing Practice (GMP) approval for this facility.

The leadership team at Prashi Pharma Private Limited includes:

• Mr. Sunil Desai: Director since October 9, 2010.
• Ms. Heena Desai Sunil: Director since October 9, 2010.
• Mr. Manthan Sunil Desai: Director since June 20, 2013.

These individuals play pivotal roles in the strategic direction and operational management of the company.

Prashi Pharma Private Limited has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company exports pharmaceutical products to various countries, with a significant focus on African nations such as Nigeria, Sierra Leone, Democratic Republic of Congo, Angola, Mali, and the Republic of Guinea. While specific regulatory approvals in these markets are not detailed in the available sources, the company's export activities suggest compliance with international standards.

Prashi Pharma has a notable presence in emerging markets, particularly in Africa. The company exports pharmaceutical products to countries including Nigeria, Sierra Leone, Democratic Republic of Congo, Angola, Mali, and the Republic of Guinea. The company's products have received approval from the African FDA, and it is in the process of obtaining WHO GMP approval, which will further facilitate access to these and other emerging markets.

Prashi Pharma's geographic strategy demonstrates a strong focus on the African continent, with exports to multiple countries in the region. This concentration indicates a strategic emphasis on emerging markets, potentially reducing exposure to risks associated with overreliance on a single region. The company's efforts to obtain WHO GMP approval suggest a commitment to meeting international standards, which may enhance its competitiveness in these markets.

Specific details regarding Prashi Pharma's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not available in the provided sources. The company's export activities to regulated markets imply adherence to international standards, but explicit FDA approvals are not documented.

Prashi Pharma is in the process of obtaining WHO GMP approval for its manufacturing facility in Shirgaon, Palghar, Maharashtra. This certification is crucial for accessing international markets and ensuring product quality. Specific details regarding EU GMP certification are not available in the provided sources.

Prashi Pharma holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility in Shirgaon, Palghar, Maharashtra, is operational and capable of producing a significant volume of pharmaceutical formulations. Specific details regarding state drug controller approvals and export No Objection Certificates (NOCs) are not available in the provided sources.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Prashi Pharma Private Limited. The company's proactive approach in seeking WHO GMP approval indicates a commitment to maintaining high manufacturing standards.

Prashi Pharma operates in a competitive pharmaceutical industry, exporting products to various countries, including those in Africa. While specific competitors are not identified in the available sources, the company's focus on emerging markets and its efforts to obtain WHO GMP approval suggest a strategy aimed at differentiating itself through quality and compliance.

Prashi Pharma's key differentiators include its significant manufacturing capacity, with the ability to produce 200 million tablets, 20 million capsules, and 1 million bottles of syrups per month. The company's focus on obtaining WHO GMP approval demonstrates a commitment to meeting international standards, which is crucial for accessing regulated markets.

Prashi Pharma's current strategic direction appears to focus on expanding its presence in emerging markets, particularly in Africa, by exporting pharmaceutical products and seeking international certifications such as WHO GMP. The company's significant manufacturing capacity supports this strategy, enabling it to meet the demands of these markets.

Prashi Pharma has a track record of exporting pharmaceutical products to various countries, including Nigeria, Sierra Leone, Democratic Republic of Congo, Angola, Mali, and the Republic of Guinea. The company's significant manufacturing capacity and efforts to obtain WHO GMP approval indicate reliability and a commitment to quality.

Importers should verify the following certifications when considering Prashi Pharma as a supplier:

• WHO GMP Certification: To ensure compliance with international manufacturing standards.

• EU GMP Certification: If exporting to European markets, to meet regulatory requirements.

• FDA Registration: For exports to the United States, to confirm compliance with FDA regulations.

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

When conducting due diligence on Prashi Pharma Private Limited, consider the following steps:

• Verify Manufacturing Certifications: Confirm WHO GMP and EU GMP certifications to ensure compliance with international standards.

• Assess Regulatory Approvals: Check for FDA registration and other relevant approvals based on target markets.

• Evaluate Financial Health: Review the company's financial statements to assess stability and capacity for large orders.

• Inspect Manufacturing Facilities: If possible, conduct site visits to evaluate production capabilities and quality control measures.

• Review Export History: Analyze the company's export records to assess reliability and consistency in fulfilling orders.

Be cautious of any discrepancies in certification dates or regulatory approvals, as these may indicate potential issues.