Warning Letter For Ankleshwar Plant Sends Wockhardt Shares To Near 2.5-Year Low
Wockhardt gets another warning letter from U.S. FDA.
Shares of Wockhardt Ltd. slumped to a 2.5-year low after the U.S. drug regulator issued yet another warning letter, this time to the pharmaceutical company's plant in Ankleshwar, Gujarat.
The U.S. Food and Drug Administration has found four violations and two deviations from current good manufacturing practice regulations at the plant.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We strongly recommend that you retain a qualified consultant to assist in your remediation.U.S. FDA Warning Letter To Wockhardt (December 23, 2016)
The regulator has directed Wockhardt to correct all violations and deviations failing which it may “withhold approval of any new applications or supplements listing your firm as a drug manufacturer”.
Wockhardt informed the exchanges that it had no further clarification to give on the warning letter.
Since the ‘import alert’ by U.S. FDA has already been effected on the said unit of the company in August 2016 and “warning letter” is a part of the same process of U.S. FDA, in view of the company, there are no further updates in this context.Workhardt’s Clarification To Exchanges
Import Ban, Then Warning Letter
The U.S. regulator had imposed an import alert on the Ankleshwar plant on August 5, 2016. Imports from two other plants, located in Chikalthana and Waluj, have also been banned by the FDA.
Usually, the FDA first releases 483 observations and then proceeds to issue the warning letter, if it is not satisfied with the remedial actions taken by the company. An import alert comes last and is the severest form of regulatory action.
However, in the case of the Ankleshwar facility, an import alert came first and then the warning letter. This generally happens in situations where the FDA finds data integrity issues.
Impact Analysis
There will be no immediate financial implications of the Ankleshwar warning letter since Wockhardt has already been barred from shipping products to the U.S. from the facility.
However, the warning letter further highlights the disappointment over the progress made by the company on addressing FDA’s concerns.
The share of global sales to Wockhardt’s revenues has fallen to 17 percent in the June to September quarter of 2016, from 26 percent in the October to December quarter of 2015.
Five Plants On Radar
The Ankleshwar plant warning letter is the latest in a series of failures by Wockhardt to meet the standards of the U.S. regulator.
- The formulations plant in Shendra has nine outstanding Form 483 observations from a January 2016 inspection. The observations include issues of data integrity and microbiological contamination of sterile products.
- The FDA issued a warning letter to CP Pharmaceuticals Ltd., a step-down subsidiary in the U.K., on November 23. The regulator sought a third party’s independent assessment of aseptic processing practices and affected batches.
- The regulator imposed an import alert on the Ankleshwar unit on August 8, 2016.
- Chikalthana and Waluj have been under import alert since 2013.
The Wockhardt stock lost 57 percent in 2016, as the regulatory cloud remained over its five plants.