Strike Three, Yer Out! FDA Bans Drug Products from Third Wockhardt Plant in India

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--In a situation that has gone from bad to worse, the U.S. Food and Drug Administration (FDA) has issued Indian drugmaker Wockhardt (Mumbai) an import alert against it manufacturing plant at Ankleshwar. The site, which manufactures active pharmaceutical ingredients (APIs), received a Form 483 following an unfavorable FDA inspection last year.

Among the many problems cited, allegedly plant employees had tried to destroy records, and inspectors were deceived about having received access to all of the facility's drug manufacturing areas. The Ankleshwar plant manufactures the APIs, which are the essential ingredients in a final drug product, for export to the U.S. and Europe. According to analysts, this single site accounts for 10-12% of the company's U.S. sales and 2-3% of overall sales.

As with other Indian generic drugmakers, the U. S. is the largest market for Wockhardt, accounting for 43% of its revenue in the quarter ended in September 2013. Prior to the latest sanction, Wockhardt's profits had already taken a severe hit, plunging 94% during the first quarter of this year.

That fall was spurred by two prior FDA regulatory actions in 2013 banning exports to the U.S. from two of the company's other Indian facilities, located in Waluj and Chikalthana. The bans followed inspections citing severe manufacturing lapses at both of the sites, which manufactured final dosage forms of generic solid dose capsules, pills, sterile injectables and tablets. For more information see February 18, 2014, article U.S. FDA Chief Visits India After Generic Drug Quality Dangers Arise.

In 2015, to ensure that all of the suspect products already shipped from those plants were off market shelves, the FDA ordered Wockhardt to issue a recall. The drugmaker recalled 7.2 million bottles, cartons, pouches and drums amounting to hundreds of millions of tablets and capsules.

The FDA revisited the Waluj plant in 2015 for a weeklong inspection, only to uncover additional problems. The initial problems discovered were serious. A warning letter at the time said that quality-assurance personnel tried to hide records of batch failures, started to destroy test samples and told inspectors they had been given access to all areas of manufacturing for U.S.-bound products. The inspectors later learned of an entire cartridge-filling production area they were not shown.

Wockhardt has eight manufacturing plant sites in India, producing both APIs and finished dose (ready to be administered to a patient) generics. Other locations include Clonmel, Ireland-generic finished dose (Pinewood Healthcare), Wrexham, United Kingdom--generic finished dose (Wockhart UK Limited) and Morton Grove, Illinois-generic finished dose (Morton Grove Pharmaceuticals).

Click here to view a chart showing active reported pharmaceutical-biotech capital projects in India, by state

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