Prosfora Technologies Private Limited

Prosfora Technologies Private Limited is a privately held pharmaceutical company established on March 30, 2015, in Navi Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U74999MH2015PTC263227. Its authorized and paid-up capital stands at ₹0.19 million (₹190,000). As of April 8, 2024, Prosfora employed 57 professionals. The company's registered office is located at Aster, Flat-402, Plot No-10, Sector-06, Kharghar, Navi Mumbai, Maharashtra, 410210. Prosfora specializes in pharmaceutical contract research and development (R&D), focusing on both drug products and drug substances. The company has developed product technologies that have been out-licensed in over 50 countries, including the European Union, the United States, Canada, Australia, New Zealand, South Africa, Brazil, Mexico, and various Middle Eastern and North African countries.

Prosfora Technologies Private Limited operates manufacturing facilities in Navi Mumbai, Maharashtra. While specific details regarding plant capacities and specializations are not publicly disclosed, the company is known for its expertise in pharmaceutical contract R&D, encompassing both drug products and drug substances. Prosfora has assisted numerous pharmaceutical manufacturing sites, including those producing Active Pharmaceutical Ingredients (APIs), Finished Dosage Forms (FDFs), and clinical centers, in obtaining regulatory accreditations from major global agencies.

The leadership team at Prosfora Technologies Private Limited comprises:

• Amit Rajan: Director since March 30, 2015.

• Ruchi Amit Rajan: Director since March 30, 2015.

Specific roles such as Chief Executive Officer (CEO) and Chief Financial Officer (CFO) are not publicly disclosed.

Prosfora Technologies Private Limited has a significant presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and New Zealand. The company has filed 15 Abbreviated New Drug Applications (ANDAs) in the U.S. through end customers. Additionally, Prosfora has filed over 150 dossiers in the European Union, United Kingdom, Australia, New Zealand, Canada, and South Africa, with many under review. These filings indicate Prosfora's commitment to meeting the stringent regulatory requirements of these markets.

Prosfora Technologies Private Limited has expanded its reach into emerging markets, including Africa, Latin America, and Southeast Asia. The company's product technologies have been out-licensed in over 50 countries, encompassing regions such as Africa, Latin America, and Southeast Asia. This strategic expansion enhances Prosfora's global footprint and access to diverse markets.

Prosfora Technologies Private Limited demonstrates a diversified geographic strategy by establishing a presence in both regulated and emerging markets. The company's significant export value of $839,000 USD across 30 shipments, primarily in the analgesics and antibiotics therapeutic categories, reflects a balanced approach to market penetration. This diversification mitigates concentration risk and positions Prosfora to leverage growth opportunities across various regions.

Specific details regarding Prosfora Technologies Private Limited's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available. The company's involvement in the U.S. market, as evidenced by the filing of 15 ANDAs through end customers, suggests compliance with FDA regulations.

Prosfora Technologies Private Limited has developed product technologies that have been out-licensed in over 50 countries, including those requiring compliance with World Health Organization (WHO) Good Manufacturing Practices (GMP) and European Union (EU) GMP standards. This indicates that Prosfora's manufacturing processes align with international quality standards, facilitating access to these markets.

Specific details regarding Prosfora Technologies Private Limited's manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), approvals from state drug controllers, and export No Objection Certificates (NOCs) are not publicly disclosed. However, the company's active participation in global markets and its role in assisting pharmaceutical manufacturing sites in obtaining regulatory accreditations suggest adherence to Indian regulatory requirements.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Prosfora Technologies Private Limited. The company's active participation in global markets and its role in assisting pharmaceutical manufacturing sites in obtaining regulatory accreditations suggest a strong compliance record.

Prosfora Technologies Private Limited operates in the competitive pharmaceutical contract research and development (R&D) sector. While specific competitors are not identified in the available data, the company's focus on both drug products and drug substances, along with its global licensing agreements, positions it as a significant player in the industry. The company's export value of $839,000 USD across 30 shipments, primarily in the analgesics and antibiotics therapeutic categories, reflects its competitive presence in these segments.

Prosfora Technologies Private Limited's key differentiators include its expertise in pharmaceutical contract R&D, encompassing both drug products and drug substances. The company's product technologies have been out-licensed in over 50 countries, including the European Union, the United States, Canada, Australia, New Zealand, South Africa, Brazil, Mexico, and various Middle Eastern and North African countries. This extensive licensing portfolio demonstrates Prosfora's capability to meet diverse regulatory requirements and market needs.

Prosfora Technologies Private Limited is strategically positioned as a contract research organization (CRO) specializing in pharmaceutical R&D, focusing on both drug products and drug substances. The company's global licensing agreements and export activities indicate a strategic direction aimed at expanding its international footprint. Future outlooks would benefit from further diversification of its product portfolio and exploration of new therapeutic areas to enhance growth prospects.

Prosfora Technologies Private Limited has a track record of assisting numerous pharmaceutical manufacturing sites, including those producing Active Pharmaceutical Ingredients (APIs), Finished Dosage Forms (FDFs), and clinical centers, in obtaining regulatory accreditations from major global agencies. This involvement suggests a reliable and consistent approach to supplier relationships, contributing to the company's reputation in the pharmaceutical industry.

Importers should verify the following certifications when considering Prosfora Technologies Private Limited as a supplier:

• FDA Facility Registration: Confirm registration status through the FDA's official database.

• WHO-GMP Certification: Verify compliance with WHO Good Manufacturing Practices by reviewing the company's certification documents.

• EU GMP Certification: Ensure adherence to European Union Good Manufacturing Practices by examining the company's EU GMP certificates.

• ISO Certifications: Assess the company's quality management systems by reviewing relevant ISO certifications.

When conducting due diligence on Prosfora Technologies Private Limited, consider the following steps:

• Verify Regulatory Compliance: Confirm FDA registration, WHO-GMP, EU GMP, and ISO certifications.

• Assess Financial Health: Review financial statements for profitability, revenue trends, and debt levels.

• Evaluate Product Portfolio: Examine the range and quality of products offered, focusing on therapeutic categories and market demand.

• Check Export Records: Analyze export volumes, consistency, and destinations to gauge market reach and reliability.

• Review Regulatory History: Investigate any past regulatory actions, including warning letters or import alerts.

Red flags to watch for include significant financial losses, regulatory non-compliance, and a limited or declining product portfolio. Recommended pre-order checks involve verifying certifications, assessing financial stability, and evaluating product quality and compliance.