Zydus Hospira Oncology Private Limited

Zydus Hospira Oncology Private Limited, incorporated on June 13, 2005, is a private limited company based in Gujarat, India. The company is registered under the Corporate Identification Number (CIN) U24230GJ2005PTC046246. Its authorized share capital is ₹65 crore, with a paid-up capital of ₹15 crore. The registered office is located at Plot No.3, Pharmez, Special Economic Zone, Sarkhej Bavla Highway, Village Matoda Tal Sanand, Gujarat 382213, India. The company's primary business activity is the manufacture of pharmaceutical and medicinal chemical products.

Zydus Hospira Oncology Private Limited operates manufacturing facilities within the Pharmez Special Economic Zone in Gujarat, India. Specific details regarding the locations, capacities, and specializations of these facilities are not publicly disclosed. However, the company's focus on oncology products suggests that these facilities are equipped to handle the production of specialized pharmaceutical formulations.

As of the latest available information, the board of directors includes Ganesh Narayan Nayak, Harish Rajendra Sadana, Nitinkumar Dalsukhray Parekh, Andrew David Chatfield, John Francis Kelly, Ranjit Menon, William Francis Barberich Jr, Swati, Pankaj Ramanbhai Patel, Sharvil Pankajbhai Patel, Pritiben Pankajbhai Patel, Vikramkumar Brijesh Shukla, Prashant Sharma, Arvind Sharma, and Sonya Kakkar. The company's leadership comprises professionals with diverse backgrounds, contributing to its strategic direction and operations.

Zydus Hospira Oncology Private Limited has engaged in regulatory processes with the U.S. Food and Drug Administration (FDA). The company has been audited by the FDA multiple times between 2009 and 2023 across its facilities. Notably, an FDA Form 483 was issued on June 30, 2023, indicating observations during an inspection. While specific details of the observations are not publicly available, such inspections are standard procedures to ensure compliance with FDA regulations. The company's engagement with the FDA suggests a commitment to meeting international regulatory standards.

Zydus Hospira Oncology Private Limited's export activities, totaling $4.7 million USD across 104 shipments, indicate a presence in various international markets. The company's focus on oncology products positions it to address the growing demand for cancer treatments in emerging markets. While specific details regarding market penetration in Africa, Latin America, and Southeast Asia are not publicly disclosed, the company's export activities suggest an expanding footprint in these regions.

The company's export data reveals a concentration in oncology products, with the top five products accounting for 100% of its export value. This indicates a focused product strategy. However, the lack of diversification in product offerings may expose the company to risks associated with market fluctuations in the oncology segment. Strategic diversification could mitigate such risks and enhance the company's resilience in the global pharmaceutical market.

Zydus Hospira Oncology Private Limited's facilities have been subject to multiple FDA inspections between 2009 and 2023. The most recent inspection resulted in an FDA Form 483 issued on June 30, 2023, indicating observations during the inspection. While specific details of the observations are not publicly available, such inspections are standard procedures to ensure compliance with FDA regulations. The company's engagement with the FDA suggests a commitment to meeting international regulatory standards.

Specific information regarding Zydus Hospira Oncology Private Limited's compliance with World Health Organization (WHO) prequalification and European Union Good Manufacturing Practice (EU GMP) standards is not publicly available. Given the company's focus on oncology products and its export activities, it is likely that the company adheres to international quality standards to meet the requirements of global markets.

Zydus Hospira Oncology Private Limited holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company's registered address in Gujarat indicates compliance with state drug controller approvals. Specific details regarding export No Objection Certificates (NOCs) are not publicly disclosed. The company's adherence to CDSCO regulations underscores its commitment to maintaining high-quality manufacturing standards.

An FDA Form 483 was issued to Zydus Hospira Oncology Private Limited on June 30, 2023, following an inspection of its facilities. While the specific observations from this inspection are not publicly available, such forms are issued when FDA investigators identify conditions that may constitute violations of the Food, Drug, and Cosmetic Act. The company has a history of FDA inspections, with previous Form 483s issued in October 2019 and April 2018. These inspections are part of the FDA's routine process to ensure compliance with regulatory standards.

In the oncology pharmaceutical sector, Zydus Hospira Oncology Private Limited faces competition from both domestic and international companies. While specific market share data is not publicly available, the company's export activities and focus on oncology products position it within a competitive landscape that includes established pharmaceutical manufacturers. The company's emphasis on quality and regulatory compliance is essential for maintaining a competitive edge in this specialized market segment.

Zydus Hospira Oncology Private Limited's specialization in oncology products allows it to focus on a niche market with high demand. The company's adherence to international regulatory standards, as evidenced by its interactions with the FDA, demonstrates a commitment to quality and compliance. These factors contribute to the company's reputation and potential for growth in the oncology pharmaceutical sector.

Zydus Hospira Oncology Private Limited's strategic direction appears to be focused on the oncology segment, with a concentrated product portfolio. While this focus allows for specialization, it also exposes the company to risks associated with market fluctuations in the oncology sector. Diversifying the product portfolio and exploring new therapeutic areas could enhance the company's resilience and growth prospects in the global pharmaceutical market.

Zydus Hospira Oncology Private Limited's export data indicates a consistent volume of shipments, reflecting reliability in its supply chain operations. The company's adherence to international regulatory standards, as evidenced by its interactions with the FDA, suggests a commitment to quality and compliance. These factors contribute to the company's reputation as a dependable supplier in the oncology pharmaceutical sector.

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

• FDA Registration: Confirm the company's registration status with the U.S. Food and Drug Administration to ensure compliance with U.S. regulations.

• WHO-GMP Certification: Verify adherence to World Health Organization Good Manufacturing Practice standards to ensure product quality.

• EU GMP Certification: Ensure compliance with European Union Good Manufacturing Practice standards for market access in EU countries.

• ISO Certification: Check for International Organization for Standardization certifications related to quality management systems.

These certifications can typically be verified through the respective regulatory bodies' official websites or by requesting documentation directly from the company.

Importers should undertake the following steps to ensure a thorough evaluation of Zydus Hospira Oncology Private Limited:

• Verify Regulatory Compliance: Confirm the company's certifications and registrations with relevant regulatory bodies, including the FDA, WHO, EU GMP, and ISO.

• Review Inspection Reports: Examine recent FDA Form 483s and other inspection reports to assess the company's compliance history.

• Assess Financial Stability: Review the company's financial statements to evaluate its financial health and operational performance.

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

• Check References: Seek feedback from other importers or partners who have previously engaged with the company.

Red flags to watch for include unresolved regulatory issues, inconsistent product quality, and financial instability. Recommended pre-order checks involve confirming the company's certifications, reviewing inspection histories, and assessing product quality through sampling.