correction

Zydus Cadila given nod to export antibiotic from US FDA warned plant

By Dan Stanton

- Last updated on GMT

Image: iStock
Image: iStock

Related tags Warning letter Mumbai Food and drug administration Fda

The US FDA has given approval to Zydus Cadila to market an antibiotic made from an Indian facility hit with a Warning Letter in December.

Two facilities located in Ahmedabad, Gujarat, were cited in a Warning Letter​ sent by the US Food and Drug Administration (FDA) in December last year after inspectors found data integrity issues and failures by the firm to investigate unexplained discrepancies and batch failures.

The Indian API and finished formulation maker said it was “committed to resolve all the issues and revamp [its] quality systems and processes,” ​and last week the firm announced it has received the nod from the Agency to market the antibiotic Doxycycline in 50, 75 and 100mg dosages.

“With this first approval, the group will now commence supplies to the US market from its formulation manufacturing facility located at the SEZ in Ahmedabad,”​ the company said in a statement filed with the Bombay Stock Exchange (BSE)​.

CORRECTION:

We originally stated that the two facilities are in the Special Economic Zone (SEZ) in Gujarat. A representative for the firm has since told us that "The two facilities mentioned in recent warning letter WL: 320-16-05 dated 23 Dec 2015, are located in Ahmedabad but not in the SEZ."

Related news

Show more

Related products

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Understanding the hidden value of quality

Understanding the hidden value of quality

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 16-Jan-2023 | White Paper

The raw material supply is too vital to leave to chance, and quality-related supply chain activities are cornerstones to your success.