Sanskruti Pharma

Sanskruti Pharma, established in 2007, is a privately held pharmaceutical company headquartered in Surat, Gujarat, India. The company operates as a trader, wholesaler, distributor, and exporter of pharmaceutical products, including tablets, capsules, syrups, and injections. Sanskruti Pharma is registered under the Goods and Services Tax (GST) with the number 24CVJPS6320K2Z8 and holds an Import Export Code (IEC) of CVJPS6320K. The firm's annual turnover ranges between ₹1.5 to ₹5 crore, and it employs between 11 to 25 individuals.

The company's legal status is that of a proprietorship, with Mr. Champakbhai Rudabhai Saliya serving as the proprietor. Sanskruti Pharma's registered office is located at Basement Part No-3, Plot No-100, 100/A, 101, 102, 103, Vasudev Nagar Society, Ved Road, Dabholi, Surat-395004, Gujarat, India.

Sanskruti Pharma operates manufacturing facilities in Surat, Gujarat, India. The company specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. While specific details regarding plant capacities and certifications are not publicly disclosed, the company emphasizes adherence to stringent quality control and testing procedures to ensure product safety and efficacy.

Mr. Champakbhai Rudabhai Saliya serves as the proprietor of Sanskruti Pharma. The company's leadership team includes Mr. Chirag Saliya, who holds the position of Chief Executive Officer (CEO). Specific details regarding other key executives, such as the Chief Financial Officer (CFO), are not publicly available.

Sanskruti Pharma's export activities are primarily focused on the African and Latin American markets, including countries such as Belize, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guyana, Paraguay, Peru, Suriname, Uruguay, Venezuela, Cuba, the Dominican Republic, and Haiti. The company has not publicly disclosed specific regulatory filings, approvals, or market access statuses in the United States, European Union, United Kingdom, Australia, or Japan.

Sanskruti Pharma has a significant presence in emerging markets, particularly in Africa and Latin America. The company's focus on these regions aligns with the World Health Organization's (WHO) prequalification program, which aims to ensure the quality, safety, and efficacy of medical products. By adhering to WHO prequalification standards, Sanskruti Pharma enhances its credibility and facilitates access to these markets.

Sanskruti Pharma's export strategy demonstrates a concentrated approach, focusing heavily on the African and Latin American markets. This geographic concentration may expose the company to risks associated with regional economic fluctuations, political instability, and regulatory changes. Diversifying its export destinations could mitigate these risks and provide a more balanced growth trajectory.

Sanskruti Pharma has not publicly disclosed any FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, or inspection histories. The company's export activities are primarily directed towards markets in Africa and Latin America, where FDA approvals may not be a prerequisite. However, obtaining FDA approvals could enhance the company's credibility and open avenues in additional regulated markets.

Sanskruti Pharma has not publicly disclosed certifications such as WHO prequalification or EU Good Manufacturing Practice (GMP) certificates. These certifications are crucial for accessing regulated markets and ensuring product quality. Pursuing such certifications could bolster the company's reputation and facilitate entry into more stringent markets.

Sanskruti Pharma 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, which are essential for domestic and international operations. Specific details regarding export No Objection Certificates (NOCs) are not publicly available.

Sanskruti Pharma has not publicly disclosed any Form 483 observations, warning letters, or import alerts from regulatory bodies. The company's focus on emerging markets may contribute to the absence of such disclosures. Maintaining compliance with international regulatory standards is essential for sustaining and expanding market access.

Sanskruti Pharma operates in a competitive landscape with numerous pharmaceutical exporters targeting similar markets in Africa and Latin America. While specific competitors are not publicly identified, the company's focus on oncology medicines, anti-cancer injections, and other specialized pharmaceutical products positions it in a niche segment. Differentiating through product quality, regulatory compliance, and customer service is crucial for maintaining a competitive edge.

Sanskruti Pharma's key differentiators include its specialization in oncology medicines and anti-cancer injections, catering to critical healthcare needs in emerging markets. The company's commitment to quality, safety, and compliance with international standards enhances its reputation among healthcare providers and patients. Additionally, its focus on emerging markets allows for tailored strategies that address specific regional healthcare challenges.

Sanskruti Pharma's current strategic direction emphasizes the export of specialized pharmaceutical formulations, particularly in the oncology segment, to emerging markets. The company's future outlook would benefit from diversifying its product portfolio, obtaining international certifications, and exploring new market opportunities to enhance growth and sustainability.

Sanskruti Pharma demonstrates a consistent track record in exporting pharmaceutical products, with a total export value of $85,000 USD across 71 shipments. The company's portfolio is concentrated, with its top two products—Rituximab and Regorafenib—accounting for 100% of its export value. This concentration indicates a focused approach but also suggests potential risks associated with market fluctuations affecting these specific products.

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

• FDA Approval: Confirm that the products are approved by the U.S. Food and Drug Administration. Verification can be done through the FDA's official website or by contacting the FDA directly.

• WHO-GMP Certification: Ensure that the manufacturing facilities adhere to the World Health Organization's Good Manufacturing Practice standards. This can be verified by reviewing the WHO's list of prequalified manufacturers.

• EU GMP Certification: Check that the products comply with European Union Good Manufacturing Practice standards. Verification can be done through the European Medicines Agency (EMA) or the European Directorate for the Quality of Medicines & HealthCare (EDQM).

• ISO Certification: Verify that the company holds relevant International Organization for Standardization certifications, such as ISO 9001 for quality management systems. This information is typically available on the company's official website or by contacting ISO directly.

Importers should undertake the following steps to ensure a thorough evaluation of Sanskruti Pharma:

• Verify Regulatory Approvals: Confirm that the products have the necessary approvals from relevant regulatory bodies, such as the FDA, WHO, or EMA.

• Assess Manufacturing Facilities: Evaluate the manufacturing facilities for compliance with international quality standards, including GMP certifications.

• Review Financial Stability: Analyze the company's financial statements to assess its financial health and ability to fulfill orders.

• Check References and Reputation: Seek feedback from existing clients and review the company's reputation in the industry.

• Inspect Product Samples: Request samples to evaluate product quality and consistency.

• Understand Export Capabilities: Ensure the company has a reliable logistics and supply chain system to meet delivery timelines.

• Monitor for Red Flags: Be vigilant for any signs of non-compliance, such as lack of certifications, negative reviews, or unexplained financial discrepancies.

By following this checklist, importers can make informed decisions and establish successful partnerships with Sanskruti Pharma.