Astral Steritech Private Limited

Astral Steritech Private Limited, established in 1991 by Dr. Dushyant R. Patel in Vadodara, Gujarat, India, began as a manufacturer of sterile Amoxicillin Sodium using indigenous technology. Over the years, the company expanded its capabilities to produce a range of sterile antibiotic injectable formulations, including Cephalosporin and Semi-Synthetic Penicillin products. In September 2012, Astral Pharmaceutical Industries was rebranded as Astral SteriTech Private Limited to emphasize its focus on sterile manufacturing.

The company is privately held, with an authorized share capital of ₹110 million and a paid-up capital of ₹92.28 million. As of March 2022, Astral Steritech reported a total revenue of ₹1.5 billion, a 35.7% decrease from the previous year, and a net worth decline of 77.21%. In August 2021, Centrient Pharmaceuticals, a global leader in beta-lactam antibiotics, acquired Astral SteriTech, enhancing its portfolio with high-quality sterile injectable antibiotic formulations.

Astral Steritech operates a state-of-the-art manufacturing facility located at 911, GIDC Makarpura, Vadodara, Gujarat, India. The plant specializes in the production of sterile antibiotic injectable formulations, including Cephalosporin and Semi-Synthetic Penicillin products. Equipped with advanced technologies from leading pharmaceutical equipment manufacturers, the facility ensures high-quality standards and efficiency across all production stages.

As of March 2022, the board of directors of Astral Steritech Private Limited included Nitish Niharkumar Chakravarty, Rohan Dheman, and Manish Kumar Santosh Buchasia. In June 2025, additional directors Kiran Mohanlal Jain, Uttamkumar Mohanlal Jain, Devangiben Jigneshkumar Shah, and Jigneshkumar Ashvinbhai Shah were appointed. The company's leadership has overseen significant developments, including the acquisition by Centrient Pharmaceuticals in August 2021.

Astral Steritech's acquisition by Centrient Pharmaceuticals in August 2021 has likely facilitated access to regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. Centrient's established presence in these regions, combined with Astral Steritech's manufacturing capabilities, positions the company to meet the stringent regulatory requirements of these markets. However, specific regulatory filings, approvals, and market access statuses for Astral Steritech's products in these regions are not publicly disclosed.

The acquisition by Centrient Pharmaceuticals has potentially enhanced Astral Steritech's ability to penetrate emerging markets in Africa, Latin America, and Southeast Asia. Centrient's global network and expertise in beta-lactam antibiotics may enable Astral Steritech to expand its reach in these regions. While the World Health Organization (WHO) prequalification can facilitate access to these markets, specific details regarding Astral Steritech's prequalification status are not publicly available.

Astral Steritech's strategic direction, under Centrient Pharmaceuticals, appears to focus on expanding its global footprint by leveraging existing manufacturing capabilities and regulatory approvals. This approach aims to diversify market presence and mitigate concentration risks associated with reliance on a limited number of markets. The emphasis on sterile antibiotic injectable formulations aligns with global healthcare needs, positioning the company for sustained growth.

Prior to its acquisition by Centrient Pharmaceuticals, Astral Steritech's manufacturing facility was US FDA-approved, enabling the production of sterile antibiotic injectable formulations for the US market. Specific details regarding approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly disclosed. The acquisition by Centrient Pharmaceuticals in August 2021 may have further streamlined regulatory processes and approvals.

While specific details regarding Astral Steritech's World Health Organization (WHO) prequalification and European Union Good Manufacturing Practice (EU GMP) certifications are not publicly available, the company's acquisition by Centrient Pharmaceuticals in August 2021 suggests adherence to international quality standards. Centrient's established presence in global markets indicates that Astral Steritech's manufacturing practices align with WHO and EU GMP requirements.

Astral Steritech holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) and state drug controllers, authorizing the production of pharmaceutical formulations in India. The company's export No Objection Certificates (NOCs) facilitate the international distribution of its products. The acquisition by Centrient Pharmaceuticals in August 2021 may have further streamlined regulatory processes and approvals.

Specific details regarding Form 483 observations, warning letters, or import alerts for Astral Steritech are not publicly available. The company's acquisition by Centrient Pharmaceuticals in August 2021 may have influenced its regulatory standing, but no adverse actions have been publicly reported.

In the sterile antibiotic injectable formulations market, Astral Steritech competes with other contract development and manufacturing organizations (CDMOs) specializing in beta-lactam antibiotics. The company's acquisition by Centrient Pharmaceuticals in August 2021 enhances its competitive position by expanding its product portfolio and leveraging Centrient's global network. Specific market share comparisons and head-to-head analyses are not publicly disclosed.

Astral Steritech's key differentiators include its specialized focus on sterile antibiotic injectable formulations, state-of-the-art manufacturing facilities, and adherence to international quality standards. The acquisition by Centrient Pharmaceuticals in August 2021 has further strengthened these capabilities, enabling the company to offer a broader range of products and services to its clients.

Under Centrient Pharmaceuticals, Astral Steritech's strategic direction focuses on expanding its global presence in the sterile antibiotic injectable formulations market. The company's emphasis on quality manufacturing and regulatory compliance positions it to meet the growing demand for beta-lactam antibiotics worldwide. Future outlooks suggest continued growth and diversification, leveraging Centrient's resources and market access.

Astral Steritech has a track record of consistent export volume and reliability, as evidenced by its total export value of $3.4 million USD across 67 shipments from 2022 to 2026. The company's portfolio concentration, with its top five products accounting for 100% of exports, indicates a focused approach to its product offerings. The acquisition by Centrient Pharmaceuticals in August 2021 may have further enhanced the company's export capabilities and consistency.

Importers should verify the following certifications when considering Astral Steritech as a supplier:

• FDA Approval: Confirm the facility's registration and product approvals with the US Food and Drug Administration (FDA).

• WHO-GMP Certification: Ensure the manufacturing facility complies with World Health Organization Good Manufacturing Practice standards.

• EU GMP Certification: Verify adherence to European Union Good Manufacturing Practice standards.

• ISO Certifications: Check for relevant 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 supplier.

When conducting due diligence on Astral Steritech, consider the following steps:

• Verify Regulatory Approvals: Confirm FDA, WHO-GMP, EU GMP, and ISO certifications.

• Assess Financial Health: Review financial statements for profitability trends and financial stability.

• Evaluate Manufacturing Capabilities: Inspect facility conditions, equipment, and adherence to quality standards.

• Review Compliance History: Check for any regulatory violations or adverse actions.

• Assess Supply Chain Reliability: Evaluate the consistency and reliability of supply and delivery schedules.

Red flags to watch for include significant financial losses, unresolved regulatory issues, and inconsistent product quality. Recommended pre-order checks involve obtaining and verifying all relevant certifications, conducting site visits, and reviewing third-party audits or assessments.