Premium Serums Vaccines Private Limited

Premium Serums and Vaccines Private Limited, established on January 29, 2009, is a private unlisted 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.

The company specializes in the manufacturing of biological products, including equine immunoglobulins and antivenoms, catering to healthcare applications. As of April 7, 2024, Premium Serums and Vaccines employed 82 professionals. The company's website, www.premiumserums.com, provides detailed information about its products and services.

Premium Serums and Vaccines operates manufacturing facilities in Maharashtra, India. The company specializes in the production of biological products, including equine immunoglobulins and antivenoms. Specific details regarding the locations and capacities of these manufacturing plants are not publicly disclosed. The facilities are designed to meet stringent quality standards, ensuring the safety and efficacy of their products.

The leadership team of Premium Serums and Vaccines Private Limited comprises:

• Shyam Bhalchandra Dhawan: Director since January 29, 2009.

• Girish Nathuram Kolwankar: Director since January 29, 2009.

Specific roles such as CEO or CFO are not publicly specified. The directors are responsible for overseeing the company's strategic direction and operations.

Premium Serums and Vaccines Private Limited's presence in regulated markets such as the United States, European Union, United Kingdom, Australia, and Japan is not publicly documented. The company primarily focuses on manufacturing biological products, including equine immunoglobulins and antivenoms, which are critical in healthcare applications. While the company has a global reach, specific regulatory filings, approvals, and market access statuses in these regions are not available in the public domain.

The company's export data indicates shipments to various countries, suggesting a presence in emerging markets. However, specific details regarding its penetration in Africa, Latin America, and Southeast Asia are not publicly available. The company's focus on manufacturing biological products, including equine immunoglobulins and antivenoms, positions it to address healthcare needs in these regions. While the company strives to explore and integrate solutions with modern technology to provide affordable treatments, specific information about WHO prequalification or other certifications enabling access to these markets is not disclosed.

Premium Serums and Vaccines Private Limited's export data indicates shipments to various countries, suggesting a diversified geographic strategy. However, specific details regarding the company's market diversification, concentration risk, and strategic direction are not publicly available. The company's focus on manufacturing biological products, including equine immunoglobulins and antivenoms, positions it to address healthcare needs in various regions. While the company strives to explore and integrate solutions with modern technology to provide affordable treatments, specific information about its geographic diversification and strategic direction is not disclosed.

Specific details regarding Premium Serums and Vaccines 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 focus on manufacturing biological products, including equine immunoglobulins and antivenoms, suggests that it may be subject to FDA regulations. However, without publicly available information, a comprehensive assessment of the company's FDA status cannot be provided.

Specific information regarding Premium Serums and Vaccines Private Limited's WHO prequalification, EU Good Manufacturing Practice (GMP) certificates, and European Directorate for the Quality of Medicines & HealthCare (EDQM) status is not publicly available. The company's focus on manufacturing biological products, including equine immunoglobulins and antivenoms, suggests that it may adhere to international quality standards. However, without publicly available information, a comprehensive assessment of the company's compliance with WHO and EU GMP standards cannot be provided.

Specific details regarding Premium Serums and Vaccines Private Limited's Central Drugs Standard Control Organisation (CDSCO) manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not publicly available. The company's focus on manufacturing biological products, including equine immunoglobulins and antivenoms, suggests that it operates in compliance with Indian regulatory standards. However, without publicly available information, a comprehensive assessment of the company's regulatory compliance cannot be provided.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Premium Serums and Vaccines Private Limited. The company's focus on manufacturing biological products, including equine immunoglobulins and antivenoms, suggests a commitment to quality and regulatory compliance. However, without publicly available information, a comprehensive assessment of the company's regulatory history cannot be provided.

Specific information regarding Premium Serums and Vaccines Private Limited's competitors in overlapping categories, market share comparisons, and head-to-head analyses is not publicly available. The company's focus on manufacturing biological products, including equine immunoglobulins and antivenoms, positions it in a niche market segment. However, without publicly available information, a comprehensive analysis of the competitive landscape cannot be provided.

Premium Serums and Vaccines Private Limited differentiates itself through its focus on manufacturing biological products, including equine immunoglobulins and antivenoms, which are critical in healthcare applications. The company's commitment to quality and affordability positions it as a leading supplier in this niche market segment. However, without publicly available information, a comprehensive assessment of the company's unique strengths and competitive advantages cannot be provided.

Premium Serums and Vaccines Private Limited's strategic direction appears to focus on the manufacturing of biological products, including equine immunoglobulins and antivenoms. The company's commitment to quality and affordability suggests a focus on addressing critical healthcare needs. However, without publicly available information, a comprehensive assessment of the company's strategic position and future outlook cannot be provided.

Specific details regarding Premium Serums and Vaccines Private Limited's track record, export volume and consistency, and reliability indicators are not publicly available. The company's focus on manufacturing biological products, including equine immunoglobulins and antivenoms, suggests a commitment to quality and reliability. However, without publicly available information, a comprehensive assessment of the company's supplier performance cannot be provided.

Importers should verify the following certifications when considering Premium Serums and Vaccines Private Limited as a supplier:

• FDA Facility Registration: To ensure compliance with U.S. regulations. Verification can be done through the FDA's official website.

• WHO-GMP Certification: To confirm adherence to World Health Organization standards. Verification can be done through the WHO's official website.

• EU GMP Certification: To ensure compliance with European Union standards. Verification can be done through the European Medicines Agency's official website.

• ISO Certification: To confirm adherence to international quality standards. Verification can be done through the International Organization for Standardization's official website.

When conducting due diligence on Premium Serums and Vaccines Private Limited, consider the following steps:

• Verify Certifications: Ensure the company holds the necessary certifications, such as FDA registration, WHO-GMP, EU GMP, and ISO.

• Assess Financial Health: Review the company's financial statements to evaluate its financial stability.

• Evaluate Product Quality: Request samples and conduct quality assessments to ensure product standards.

• Check Regulatory Compliance: Confirm the company's compliance with relevant regulatory bodies.

• Review Export History: Assess the company's export records to evaluate reliability and consistency.

Be cautious of red flags such as lack of transparency, unresolved regulatory issues, or inconsistent financial records. Recommended pre-order checks include verifying certifications, assessing financial health, and evaluating product quality.