AET Laboratories Private Limited

AET Laboratories Private Limited, incorporated on September 24, 2003, is a private limited company based in Telangana, India. The company is registered under the Corporate Identification Number (CIN) U24239TG2003PTC041756. Its authorized share capital is ₹150,000,000, with a paid-up capital of ₹81,778,820. The registered office is located at Survey No.42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502319, India.

AET Laboratories specializes in the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company has a workforce of approximately 304 employees as of April 5, 2024.

The company's manufacturing facility is situated in the Kazipally Industrial Area of Sangareddy, Telangana. While specific production capacities and specializations are not publicly disclosed, the facility is equipped to produce a range of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections.

As of September 30, 2022, Swapnil Singh serves as the Managing Director of AET Laboratories Private Limited. Other key directors include Oliver Robert Alexander Schrader and Kristian Philip Ruepp, both appointed on March 6, 2019, and Dieter Schoenfeld, appointed on January 21, 2004. Dr. Georg Stark joined the board on September 1, 2015.

AET Laboratories Private Limited has established a presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has obtained regulatory approvals for its products in these regions, facilitating market access and distribution. Specific details regarding regulatory filings, approvals, and market access status are not publicly disclosed.

AET Laboratories has expanded its reach into emerging markets across Africa, Latin America, and Southeast Asia. The company's products have been prequalified by the World Health Organization (WHO), enabling access to these regions and enhancing its global footprint.

The company's geographic strategy demonstrates a balanced approach, with a significant focus on advanced antifungal medications, particularly posaconazole, which constitutes 87.5% of its export value. This concentration indicates a strategic emphasis on specialized therapeutic areas, potentially reducing exposure to market fluctuations in other segments.

AET Laboratories Private Limited has registered its manufacturing facility with the U.S. Food and Drug Administration (FDA), allowing for the export of its pharmaceutical products to the United States. The company has filed Abbreviated New Drug Applications (ANDAs) for its products, seeking approval for marketing in the U.S. Specific details regarding Drug Master File (DMF) filings and inspection history are not publicly disclosed.

The company's products have been prequalified by the World Health Organization (WHO), ensuring compliance with international quality standards. Additionally, AET Laboratories holds European Union Good Manufacturing Practice (EU GMP) certificates, affirming adherence to EU regulations for pharmaceutical manufacturing. The company's status with the European Directorate for the Quality of Medicines & HealthCare (EDQM) is not publicly disclosed.

AET Laboratories Private Limited holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company has obtained approvals from state drug controllers and export No Objection Certificates (NOCs), facilitating the export of its products to various international markets.

As of March 28, 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to AET Laboratories Private Limited by regulatory authorities.

In the advanced antifungal medication segment, AET Laboratories Private Limited faces competition from other pharmaceutical companies specializing in similar therapeutic areas. The company's market share in posaconazole is 5.3%, indicating a competitive position within this niche market. Specific market share comparisons and head-to-head analyses with competitors are not publicly disclosed.

AET Laboratories' key differentiators include its specialized focus on advanced antifungal medications, particularly posaconazole, and its established presence in both regulated and emerging markets. The company's WHO prequalification and EU GMP certifications further enhance its credibility and appeal to international clients.

AET Laboratories Private Limited's current strategic direction centers on the production and export of specialized pharmaceutical formulations, with a strong emphasis on advanced antifungal medications. The company's future outlook includes expanding its product portfolio and exploring new therapeutic areas to diversify its offerings and mitigate market risks.

AET Laboratories has demonstrated a consistent track record in exporting pharmaceutical products, with a total export value of $6.9 million USD and 142 shipments across three therapeutic categories. The company's portfolio concentration, with the top five products accounting for 100% of its export value, indicates a focused approach to product offerings. Reliability indicators, such as on-time delivery and product quality, are not publicly disclosed.

Importers should verify the following certifications when considering AET Laboratories Private Limited as a supplier:

• FDA Facility Registration: Confirm the company's registration status with the U.S. Food and Drug Administration.

• WHO-GMP Certification: Ensure the company holds a valid World Health Organization Good Manufacturing Practice certification.

• EU GMP Certification: Verify the company's compliance with 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 contacting the company directly.

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

• Verify Regulatory Approvals: Confirm the company's approvals from relevant regulatory authorities in target markets.

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

• Evaluate Manufacturing Capabilities: Assess the company's manufacturing facilities for compliance with quality standards and production capacity.

• Check for Compliance Issues: Investigate any past regulatory actions, such as warning letters or import alerts.

• Review Product Portfolio: Examine the company's product offerings to ensure alignment with market needs and quality expectations.

Red flags to watch for include unresolved regulatory issues, financial instability, and discrepancies in product quality. Recommended pre-order checks involve obtaining samples for quality assessment and verifying the company's supply chain reliability.