Never miss a great news story!
Get instant notifications from Economic Times
AllowNot now


You can switch off notifications anytime using browser settings.
11,898.40-39.1
Stock Analysis, IPO, Mutual Funds, Bonds & More

FDA pulls up Aurobindo Pharma for 'repeated' failures in CGMP

The FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from CGMP for API.

PTI|
Jul 03, 2019, 06.33 PM IST
0Comments
Agencies
1
Aurobindo had earlier said it believes the existing business from unit XI facility would not be impacted after receiving the warning letter for it.
HYDERABAD: The US Food and Drug Administration (FDA) has pulled up Aurobindo Pharma for 'repeated' violations in current good manufacturing practice (CGMP) at three of its plants in manufacturing certain active pharmaceutical ingredients (API) and intermediates.

The FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from CGMP for API.

"The FDA cited similar CGMP observations at other facilities in your companys network," the letter said.

Aurobindo unit I and Aurobindo unit IX were also inspected and cited for CGMP deficiencies related to the manufacture of (b)(4) API and intermediates.

These facilities were also considered to be in an unacceptable state of compliance with regards to CGMP.

The repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate, the regulator said.

In the letter issued on June 20 for unit XI which was inspected between February 4 and 9 the FDA said the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP and the API are adulterated within the meaning of US laws.

The FDA directed the firm, among others, to provide a comprehensive assessment of the state of maintenance of all equipment that can be used in the manufacture of drugs for the United States.

Aurobindo had earlier said it believes the existing business from unit XI facility would not be impacted after receiving the warning letter for it.

"We will be engaging with the regulator and are fully-committed to resolving this issue at the earliest," Aurobindo said.

The company is also committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, the company added.

Also Read

US health regulator finds Silvassa unit non-compliant with CGMP: Ipca Labs

Making Ranbaxy units cGMP compliant time consuming: Sun Pharma

USFDA warns Sri Krishna Pharma for CGMP norm violations

Comments
Add Your Comments
Commenting feature is disabled in your country/region.
Download The Economic Times Business News App for the Latest News in Business, Sensex, Stock Market Updates & More.

Other useful Links


Follow us on


Download et app


Copyright © 2019 Bennett, Coleman & Co. Ltd. All rights reserved. For reprint rights: Times Syndication Service