Cadila gets US drug regulator’s warning over quality issues

The company says it will action but stock market not convinced

GN Bureau | December 31, 2015



Cadila Healthcare Ltd said it received a warning from US health regulators for violating manufacturing standards at two production sites in India. The letter from the US Food and Drug Administration cites issues at Cadila's plants in Moraiya drug production site and another in Ahmedabad city where it makes drug ingredients.

Strangely, the company says that there are no products in the US market which use API of Zyfine facility.

On Thursday, Cadila said in a statement that it was "committed to resolve all the issues and revamp our quality systems and processes as the top most priority."

“The company has received a warning letter issued by the US FDA relating to its Moraiya formulation facility and Ahmedabad API facility (Zyfine),” Cadila Healthcare said in a regulatory filing.

Cadila said none of its products being sold in the United States used any raw materials made at the Ahmedabad plant.

"The company said it will respond to US FDA to address the observations within the statutory time permitted in the letter. The company is working hard to ensure that the commitments made to the US FDA are fully completed. The company will continue to take all necessary steps to ensure that the US FDA is fully satisfied with our remediation of the above facilities," it added.

Despite these clarifications, its shares fell by 17%. This is its biggest single-day percentage fall.

Cadila has already gained site transfer approvals for 4 of its existing products. Also, its new SEZ formulations facility (oral Oncology, oral solids) received the Establishment Inspection Report (EIR) from the USFDA.

The warning for Moraiya comes more than a year after the FDA inspected the plant in 2014, and issued a report highlighting a series of problems. Cadila said in October its work to fix the issues was complete.

Comments

 

Other News

Stories you must read over the weekend

Joseph A Cannataci is the UN’s first and current special rapporteur for the right to privacy appointed by the Human Rights Council (HRC) in July 2015. His appointment came with growing global concerns about threats to privacy in the digital age where governments and big corporations collect mass da

When Jaitley sparred with Chidambaram

This is what Arun Jaitley had to say:   We want to take action which may either want to have an assault on what is the shadow economy or the parallel economy itself. Let us take this example of what everybody has commented on Section 132. Section 132, in simple,

One country, one tax from July 1

 After an intense seven-hour-long debate in the Lok Sabha, the cabinet gave a nod to the Goods and Services Tax (GST) Bill. A green signal has also been given to the four crucial supplementary bills; Central Goods and Services Tax (CGST) Bill, Integrated GST (IGST) Bill, Compensation GST (compensation

Indian team’s internet access to villages gets global recognition

 A successful effort to take high speed internet to over six lakh Indian villages by an IIT Bombay team failed to get support from the government. But, the same indigenous television white space technology developed by the team has now won Mozilla Corporation’s ‘equal rating innovation cha

DJB unveils Yamuna river project

Delhi Jal Board, in collaboration with University of Virginia on Thursday unveiled the Yamuna River Project with a symposium cum exhibition as a part of the overall effort to map out an expansive, multidisciplinary prescription to clean Yamuna. The discussion opened on the lines of eradicati

UJALA scheme: Over 22 crore LED bulbs distributed

  Over 22 crore LED bulbs have been distributed by Energy Efficiency Services Limited (EESL) under UJALA scheme, union minister Piyush Goyal informed the Lok Sabha.   The minister said that the National LED programme, called Unnat Jyoti by Affordable LEDs for

Video

Current Issue

Opinion

Facebook    Twitter    Google Plus    Linkedin    Subscribe Newsletter

Twitter