Pfizer Healthcare India Private Limited

Pfizer Healthcare India Private Limited, established on November 17, 2009, is a private unlisted company headquartered in Chennai, Tamil Nadu, India. The company is registered under the Corporate Identification Number (CIN) U24232TN2009PTC073563. Its authorized capital stands at ₹8.00 crore, with a paid-up capital of ₹6.93 crore. As of April 4, 2024, Pfizer Healthcare India employed approximately 3,733 professionals. The registered office is located at Emerald Building No. 237, Anna Salai, Chennai, Tamil Nadu, 600006.

Pfizer Healthcare India operates manufacturing facilities in Sriperumbudur, Tamil Nadu, within the SIPCOT Industrial Park. The plant specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Specific details regarding production capacities and specialized manufacturing processes are not publicly disclosed.

The company's leadership comprises several directors and key managerial personnel. As of the latest available information, the directors include Andrew David Chatfield, Kannan Natarajan, Fiona Kathleen Maccarthy, Andrew Gordon Mc Killop, Wriju Ghosh, and Muralidhar B Sharma. Jayaraman Aparajith serves as the Company Secretary. The exact roles and responsibilities of each director are not specified in the available sources.

Pfizer Healthcare India Private Limited's export activities are primarily focused on finished pharmaceutical formulations, with a total export value of $2.2 million USD across 44 shipments. The exported products include Heparin and Furosemide, which fall under the therapeutic categories of Cardiovascular and Diuretics, respectively. The company's export portfolio is concentrated, with the top five products accounting for 100% of the export value. Specific details regarding regulatory filings, approvals, and market access status in the US, EU, UK, Australia, and Japan are not publicly available.

Pfizer Healthcare India's export data indicates a focus on markets within the Cardiovascular and Diuretics therapeutic categories. However, specific information regarding the company's presence in emerging markets such as Africa, Latin America, and Southeast Asia, as well as WHO prequalification enabling access, is not publicly disclosed.

The company's export strategy appears to be concentrated, with a portfolio comprising only two products across two therapeutic categories. This focus may indicate a strategic direction aimed at specialization within these categories. However, the limited diversification could also pose concentration risks, especially if market dynamics shift or if there are regulatory challenges in the target markets.

Specific details regarding Pfizer Healthcare India'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 export data does not provide insights into its activities related to the US market.

Information regarding Pfizer Healthcare India's WHO prequalification status, EU Good Manufacturing Practice (GMP) certificates, and European Directorate for the Quality of Medicines & HealthCare (EDQM) status is not publicly disclosed. The company's export data does not indicate specific certifications or approvals from these regulatory bodies.

Pfizer Healthcare India holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) and has approvals from state drug controllers. The company has also obtained export No Objection Certificates (NOCs) for its products. Specific details regarding these licenses and approvals are not publicly available.

There is no publicly available information regarding any Form 483 observations, warning letters, or import alerts issued to Pfizer Healthcare India. The company's export data does not indicate any regulatory actions or compliance issues.

Pfizer Healthcare India's export portfolio is concentrated in the Cardiovascular and Diuretics therapeutic categories, with Heparin and Furosemide being the primary products. The company's market share in these categories is relatively small, with Heparin at 0.4% and Furosemide at 0.9%. Specific information regarding top competitors in these overlapping categories and a detailed market share comparison are not publicly available.

Pfizer Healthcare India's export portfolio is highly concentrated, with the top five products accounting for 100% of the export value. This focus may allow the company to specialize and achieve efficiencies in production and distribution. However, the lack of diversification could also expose the company to risks associated with market fluctuations and regulatory changes in the target markets.

The company's export strategy appears to be focused on finished pharmaceutical formulations in the Cardiovascular and Diuretics therapeutic categories. The limited diversification suggests a strategic direction aimed at specialization within these areas. The future outlook may involve expanding the product portfolio and exploring new markets to mitigate concentration risks and enhance growth opportunities.

Pfizer Healthcare India's export data indicates a consistent volume of shipments, with a total export value of $2.2 million USD across 44 shipments. The company's focus on finished pharmaceutical formulations suggests a commitment to quality and compliance with international standards. However, the limited diversification in the product portfolio may impact the company's ability to adapt to changing market demands and regulatory environments.

Importers should verify the following certifications when considering products from Pfizer Healthcare India:

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

• WHO-GMP Certification: Ensure that the manufacturing facilities comply with the World Health Organization's Good Manufacturing Practice (GMP) standards. This can be verified by checking the WHO's official website or contacting the organization.

• EU GMP Certification: Check that the products meet the European Union's GMP 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 manufacturing processes adhere to International Organization for Standardization (ISO) standards. This information can typically be found on the company's official website or by contacting the company directly.

When conducting due diligence on Pfizer Healthcare India Private Limited, consider the following steps:

• Verify Regulatory Approvals: Confirm that the company's products are approved by relevant regulatory bodies in target markets, such as the FDA, WHO, EMA, and CDSCO.

• Assess Manufacturing Compliance: Ensure that the manufacturing facilities comply with international GMP standards and hold necessary certifications.

• Evaluate Financial Health: Review the company's financial statements to assess profitability, revenue growth, and overall financial stability.

• Examine Product Portfolio: Analyze the product portfolio for diversification and alignment with market demands.

• Check for Regulatory Actions: Investigate any past or ongoing regulatory actions, such as warning letters or import alerts, that may impact the company's operations.

• Assess Supply Chain Reliability: Evaluate the consistency and reliability of the company's supply chain, including lead times and delivery performance.

By following this checklist, importers can make informed decisions regarding potential partnerships with Pfizer Healthcare India Private Limited.