Athena Drug Delivery Solutions Private Limited

Athena Drug Delivery Solutions Private Limited, established on November 16, 1995, is a private pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company specializes in the development and manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. With an authorized capital of ₹50.75 crore and a paid-up capital of ₹27.83 crore, Athena operates as a non-government, unlisted entity.

The company's Corporate Identification Number (CIN) is U24230MH1995PTC094546, and it is registered under the Registrar of Companies, Mumbai. As of the latest available data, Athena employs approximately 178 professionals. The company's registered office is located at 602, 6th Floor, Tower-II, 'Star Hub' International Airport Road, Sahar, Andheri (E), Mumbai, Maharashtra, 400059, India.

Athena Drug Delivery Solutions Private Limited operates a manufacturing facility in Ambernath, approximately 60 kilometers north of Mumbai, India. This facility is approved for European Union Good Manufacturing Practice (EU GMP), indicating compliance with stringent international quality standards. The plant specializes in the production of oral drug delivery systems, including effervescent tablets, oro-dispersible tablets, and modified drug release formulations. These products cater to therapeutic areas such as pain management, central nervous system disorders, cardiometabolic conditions, gastroenterology, and gynecology.

The leadership team at Athena Drug Delivery Solutions Private Limited comprises several key individuals:

• Mahendra Baliram Chaudhari: Managing Director since April 10, 2018.

• Alexandre Luc Williams: Whole-Time Director since March 8, 2011.

• Maryline Williams: Director since April 6, 2017.

• Tejas Ravikant Gawade: Company Secretary since April 16, 2018.

• Subhash Kumar Madhavan Thalodil: Chief Financial Officer since November 8, 2023.

Athena Drug Delivery Solutions Private Limited has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facility in Ambernath holds EU GMP certification, facilitating access to European markets. While specific regulatory approvals in the United States, United Kingdom, Australia, and Japan are not detailed in the available sources, the EU GMP certification suggests a commitment to meeting international quality standards, which is often a prerequisite for market entry in these regions.

Athena Drug Delivery Solutions Private Limited has expanded its reach into emerging markets across Africa, Latin America, and Southeast Asia. The company's focus on developing lifecycle products and its broad range of technology platforms for oral delivery, including modified release formulations and oro-dispersible dosage forms, position it well to meet the diverse needs of these regions. Additionally, the EU GMP certification of its manufacturing facility in Ambernath enhances its ability to meet international quality standards, facilitating access to these emerging markets.

Athena Drug Delivery Solutions Private Limited demonstrates a strategic approach to geographic diversification. The company's manufacturing facility in Ambernath, India, is EU GMP certified, enabling access to European markets. While specific details regarding operations in the United States, United Kingdom, Australia, and Japan are not provided, the EU GMP certification suggests a commitment to meeting international quality standards, which is often a prerequisite for market entry in these regions. The company's expansion into emerging markets across Africa, Latin America, and Southeast Asia further indicates a strategic focus on diversifying its geographic footprint to mitigate concentration risks and capitalize on growth opportunities in various regions.

Specific details regarding Athena Drug Delivery Solutions Private Limited's interactions with the U.S. Food and Drug Administration (FDA) are not available in the provided sources. The company's EU GMP certification of its manufacturing facility in Ambernath suggests adherence to international quality standards, which is often a prerequisite for market entry in regulated markets like the United States. However, without explicit information on FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, or inspection history, a comprehensive assessment of the company's FDA status cannot be made.

Athena Drug Delivery Solutions Private Limited's manufacturing facility in Ambernath, India, holds EU GMP certification, indicating compliance with European Union Good Manufacturing Practice standards. While the available sources do not specify whether the facility holds World Health Organization (WHO) prequalification, the EU GMP certification suggests a commitment to meeting international quality standards, which is often a prerequisite for obtaining WHO prequalification.

Athena Drug Delivery Solutions Private Limited operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility in Ambernath is EU GMP certified, indicating compliance with international quality standards. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, or export No Objection Certificates (NOCs) are not provided in the available sources.

The available sources do not provide information on any recent regulatory actions involving Athena Drug Delivery Solutions Private Limited, such as Form 483 observations, warning letters, or import alerts. The company's EU GMP certification of its manufacturing facility in Ambernath suggests adherence to international quality standards, which may mitigate the likelihood of such regulatory actions.

Athena Drug Delivery Solutions Private Limited operates in a competitive landscape with several key players in the pharmaceutical industry. While specific market share data is not available in the provided sources, the company's focus on developing lifecycle products and its broad range of technology platforms for oral delivery, including modified release formulations and oro-dispersible dosage forms, position it to compete effectively in therapeutic areas such as pain management, central nervous system disorders, cardiometabolic conditions, gastroenterology, and gynecology.

Athena Drug Delivery Solutions Private Limited differentiates itself through its commitment to developing lifecycle products and its broad range of technology platforms for oral delivery. The company's focus on modified release formulations and oro-dispersible dosage forms allows it to address diverse therapeutic areas, including pain management, central nervous system disorders, cardiometabolic conditions, gastroenterology, and gynecology. Additionally, the EU GMP certification of its manufacturing facility in Ambernath underscores its adherence to international quality standards, enhancing its credibility in the global market.

Athena Drug Delivery Solutions Private Limited's strategic direction focuses on the development of lifecycle products and the utilization of advanced technology platforms for oral drug delivery. The company's emphasis on modified release formulations and oro-dispersible dosage forms enables it to cater to a wide range of therapeutic areas, including pain management, central nervous system disorders, cardiometabolic conditions, gastroenterology, and gynecology. The EU GMP certification of its manufacturing facility in Ambernath reflects a commitment to meeting international quality standards, positioning the company favorably for future growth and expansion in both regulated and emerging markets.

Athena Drug Delivery Solutions Private Limited demonstrates a strong track record in the pharmaceutical industry, with a focus on developing lifecycle products and utilizing advanced technology platforms for oral drug delivery. The company's manufacturing facility in Ambernath, India, holds EU GMP certification, indicating adherence to international quality standards. While specific details regarding export volume and consistency are not provided in the available sources, the company's strategic focus on diverse therapeutic areas and its commitment to quality suggest reliability as a supplier.

Importers should verify the following certifications when considering Athena Drug Delivery Solutions Private Limited as a supplier:

• EU GMP Certification: Confirm the validity of the EU GMP certification of the manufacturing facility in Ambernath, India, to ensure compliance with European Union Good Manufacturing Practice standards.

• WHO Prequalification: