Zentiva Private Limited

Zentiva Private Limited is a pharmaceutical manufacturing company incorporated on July 24, 2019, under the Corporate Identification Number (CIN) U24100GJ2019FTC122980. The company is registered in Gujarat, India, with its registered office located at Plot No. 3501 to 3515, 6301 to 6313, 16 Meter Road/C, GIDC Ankleshwar, Bharuch, Gujarat, 393002. As of December 17, 2025, the company has an authorized share capital of ₹70,000,000 and a paid-up capital of ₹67,500,000. Zentiva Private Limited is a subsidiary of Zentiva Group, a global pharmaceutical company headquartered in Prague, Czech Republic.

Zentiva Private Limited operates a manufacturing facility in Ankleshwar, Gujarat, India. This site specializes in the production of oral solid dosage forms, active pharmaceutical ingredients (APIs), and intermediates. The facility is equipped with advanced global technologies and complies with both international Good Manufacturing Practice (GMP) standards and local regulatory requirements, ensuring its readiness for export to a wide range of markets.

As of December 17, 2025, the board of directors of Zentiva Private Limited includes:

• Steffen Matthias Saltofte
• Sathyabalan
• Thomas Cornelis Koene
• Anant Anand Atal

These directors oversee the strategic direction and operations of the company.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, is registered with the U.S. Food and Drug Administration (FDA). This registration indicates the company's compliance with FDA standards for drug manufacturing. Additionally, the facility adheres to international GMP standards, facilitating access to various regulated markets.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, is registered with the U.S. Food and Drug Administration (FDA). Additionally, the facility adheres to international GMP standards, facilitating access to various regulated markets.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, is registered with the U.S. Food and Drug Administration (FDA). Additionally, the facility adheres to international GMP standards, facilitating access to various regulated markets.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, is registered with the U.S. Food and Drug Administration (FDA). This registration indicates the company's compliance with FDA standards for drug manufacturing. The facility has undergone multiple FDA inspections, with some resulting in observations. However, the company has taken corrective actions to address these observations, as indicated by the absence of subsequent warning letters or import alerts.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, adheres to international Good Manufacturing Practice (GMP) standards, ensuring compliance with both international and local regulatory requirements. This adherence facilitates the facility's readiness for export to a wide range of markets.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, is registered with the U.S. Food and Drug Administration (FDA). Additionally, the facility adheres to international Good Manufacturing Practice (GMP) standards, ensuring compliance with both international and local regulatory requirements. This adherence facilitates the facility's readiness for export to a wide range of markets.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, has undergone multiple FDA inspections, with some resulting in observations. However, the company has taken corrective actions to address these observations, as indicated by the absence of subsequent warning letters or import alerts.

Zentiva Private Limited operates in the pharmaceutical manufacturing sector, competing with other companies in the production of generic and over-the-counter medicines. The company's manufacturing facility in Ankleshwar, Gujarat, is registered with the U.S. Food and Drug Administration (FDA), indicating compliance with FDA standards for drug manufacturing. Additionally, the facility adheres to international Good Manufacturing Practice (GMP) standards, ensuring its readiness for export to a wide range of markets.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, is registered with the U.S. Food and Drug Administration (FDA), indicating compliance with FDA standards for drug manufacturing. Additionally, the facility adheres to international Good Manufacturing Practice (GMP) standards, ensuring its readiness for export to a wide range of markets.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, is registered with the U.S. Food and Drug Administration (FDA), indicating compliance with FDA standards for drug manufacturing. Additionally, the facility adheres to international Good Manufacturing Practice (GMP) standards, ensuring its readiness for export to a wide range of markets.

Zentiva Private Limited's manufacturing facility in Ankleshwar, Gujarat, is registered with the U.S. Food and Drug Administration (FDA), indicating compliance with FDA standards for drug manufacturing. Additionally, the facility adheres to international Good Manufacturing Practice (GMP) standards, ensuring its readiness for export to a wide range of markets.

Importers should verify the following certifications for Zentiva Private Limited:

• FDA Registration: Confirm the facility's registration with the U.S. Food and Drug Administration (FDA) to ensure compliance with FDA standards for drug manufacturing.

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

• EU GMP Certification: Confirm compliance with European Union (EU) Good Manufacturing Practice (GMP) standards for access to European markets.

• ISO Certification: Check for International Organization for Standardization (ISO) certifications relevant to pharmaceutical manufacturing to ensure quality management systems are in place.

When conducting due diligence on Zentiva Private Limited, consider the following steps:

• Verify Regulatory Compliance: Confirm the facility's registration with the FDA and adherence to WHO-GMP and EU GMP standards.

• Review Inspection History: Examine FDA inspection reports for any observations or violations and assess the company's corrective actions.

• Assess Financial Stability: Review the company's financial statements to evaluate its financial health and capacity to fulfill orders.

• Evaluate Supply Chain Reliability: Assess the company's track record in meeting delivery schedules and maintaining product quality.

• Check Certifications: Verify the validity of all relevant certifications, including ISO and GMP certifications.

Red flags to watch for include unresolved regulatory issues, financial instability, and a history of supply chain disruptions.