Premium Serums AND Vaccines Private Limited

Premium Serums and Vaccines Private Limited, established on January 29, 2009, is a private limited company headquartered in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24110MH2009PTC189968. Its authorized and paid-up capital stands at ₹2.00 crore each. The registered office is located at 406, B Wing, Highway Rose Co-Op Hsg Society 92, Dixit Road Extension, Vile Parle (East), Mumbai, Maharashtra, 400057.

As of April 7, 2024, Premium Serums and Vaccines employed 82 professionals. The company's leadership comprises Directors Shyam Bhalchandra Dhawan and Girish Nathuram Kolwankar. In the fiscal year ending March 31, 2023, the company reported a 48.43% increase in total revenue, a 27.35% rise in profit, and a significant 386.65% growth in net worth.

Premium Serums and Vaccines operates manufacturing facilities in Pune, Maharashtra, and Narayangaon, Maharashtra. The Pune facility is situated at Gate No. 354-1, 354-2, At/Po, Pune, Maharashtra, 410504. The Narayangaon facility is located in the Pune district. These facilities specialize in the production of equine immunoglobulin products, including antivenoms, antitoxins, serums, and vaccines.

The company's leadership includes Directors Shyam Bhalchandra Dhawan and Girish Nathuram Kolwankar. Specific roles such as CEO, MD, and CFO are not publicly disclosed. The company employs a team of 82 professionals as of April 7, 2024.

Premium Serums and Vaccines Private Limited's export data indicates a total export value of $2.8 million USD across 102 shipments, with products spanning one therapeutic category. The top two products, Serum and Antitoxin, each contributed $1.4 million USD, accounting for 5.3% and 10.1% market share, respectively. The company's portfolio is highly concentrated, with the top five products comprising 100% of exports. Specific regulatory approvals in the US, EU, UK, Australia, and Japan are not publicly disclosed.

The company's export data does not specify its presence in African, Latin American, or Southeast Asian markets. Additionally, there is no publicly available information regarding WHO prequalification status, which is essential for accessing certain international markets.

Premium Serums and Vaccines Private Limited's export data indicates a highly concentrated portfolio, with the top five products comprising 100% of exports. This suggests a focused geographic strategy, potentially limiting exposure to market diversification risks. However, the lack of detailed information on geographic diversification and market penetration strategies makes it challenging to assess the company's overall geographic strategy comprehensively.

Specific information regarding FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history for Premium Serums and Vaccines Private Limited is not publicly available. The company's export data does not provide insights into its regulatory standing with the FDA.

There is no publicly available information regarding WHO prequalification, EU Good Manufacturing Practice (GMP) certificates, or European Directorate for the Quality of Medicines & HealthCare (EDQM) status for Premium Serums and Vaccines Private Limited. These certifications are crucial for market access in various international regions.

Specific details about the company'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. The company's export data does not provide insights into its regulatory standing within India.

There is no publicly available information regarding Form 483 observations, warning letters, or import alerts associated with Premium Serums and Vaccines Private Limited. The company's export data does not indicate any recent regulatory actions or compliance issues.

Premium Serums and Vaccines Private Limited operates in the equine immunoglobulin product segment, competing with other manufacturers in the antivenom, antitoxin, serum, and vaccine markets. Specific market share comparisons and head-to-head analyses are not publicly available. The company's export data indicates a highly concentrated product portfolio, which may impact its competitive positioning.

The company's focus on equine immunoglobulin products, including antivenoms, antitoxins, serums, and vaccines, positions it as a specialized manufacturer in this niche segment. However, the lack of detailed information on product innovations, quality certifications, and unique selling propositions makes it challenging to identify specific competitive advantages.

Premium Serums and Vaccines Private Limited's export data indicates a highly concentrated product portfolio, with the top five products comprising 100% of exports. This suggests a focused strategic direction, potentially limiting exposure to market diversification risks. However, the lack of detailed information on the company's strategic initiatives, such as expansion into generics, specialty drugs, biosimilars, or Contract Development and Manufacturing Organization (CDMO) services, makes it challenging to assess its future outlook comprehensively.

The company's export data indicates a total export value of $2.8 million USD across 102 shipments, with products spanning one therapeutic category. The top two products, Serum and Antitoxin, each contributed $1.4 million USD, accounting for 5.3% and 10.1% market share, respectively. The company's portfolio is highly concentrated, with the top five products comprising 100% of exports. Specific information regarding the company's track record, export volume consistency, and reliability indicators is not publicly available.

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

• FDA Approval: Confirm that the company's 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 company directly.

• WHO-GMP Certification: Ensure that the manufacturing facilities comply with the World Health Organization's Good Manufacturing Practice standards. This can be verified by reviewing the company's certifications or contacting the WHO.

• EU GMP Certification: Check that the company holds Good Manufacturing Practice certification from the European Union. Verification can be done through the European Medicines Agency or the company's official documentation.

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

When considering a partnership or procurement from Premium Serums and Vaccines Private Limited, importers should undertake the following verification steps:

• Regulatory Compliance: Confirm that the company's products are approved by relevant regulatory bodies in the target market.

• Quality Certifications: Ensure that the company holds necessary quality certifications, such as WHO-GMP, EU GMP, and ISO.

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

• Product Portfolio: Evaluate the diversity and quality of the company's product offerings to ensure they meet market demands.

• Supply Chain Reliability: Assess the company's supply chain capabilities to ensure timely and consistent product delivery.

Red flags to watch for include a lack of transparency in regulatory approvals, absence of quality certifications, financial instability, limited product diversity, and unreliable supply chain practices.

Recommended pre-order checks involve verifying the company's compliance with import regulations, confirming the authenticity of certifications, and conducting a thorough assessment of product quality and safety standards.