The Centre for Drug Evaluation & Research, an arm of the US Food & Drug Administration (US FDA), has approved Wockhardt's sterile injectable facility as well as facilities for sterile bulk drugs (active pharmaceutical ingredient) and formulations spread over three locations in India. The approvals have come in a record time of five months in the very first inspection, a company release said.
"The approvals received are for both sterile injectable as well as APIs (Active Pharmaceutical Ingredients) and formulation plants. The speedy approvals from US FDA of all the six plants at Aurangabad, Waluj and Ankleshwar, in the first attempt, is not only a tribute to US FDA's efficiency, but it also highlights Wockhardt's meticulous commitment to world-class quality and adherence to good manufacturing practices. This has become part of our culture in pursuit of globalisation," said Wockhardt's chairman, Habil Khorakiwala.
Besides, visiting Wockhardt plants, the US FDA team also reviewed the progress of Wockhardt's ANDAs (abbreviated new drug applications). The approvals are expected soon.
In addition, the Medicines and Healthcare products Regulatory Agency (MHRA) of UK too has approved Wockhardt's Aurangabad facility for sterile formulations in a record time of less than six months, reflecting the maturity and quality compliance culture of the company.
In April, Wockhardt had announced the establishment Wockhardt USA Inc, a sales and marketing subsidiary in the US, and the appointment of Arthur Maher, a marketing veteran with two decades of experience in the US industry.
Wockhardt has so far applied for 17 ANDAs for marketing its packaged formulations in the US, of which the US FDA has approved nine. The company plans to apply for 15 ANDAs this year. It has filed 32 DMF (drug master file) applications for export of active pharmaceutical ingredients to the US. Wockhardt also has five CEP (Certificate of European Pharmacopoeia) approvals for export to the European Union, the release said.
More than 150 professionals at various levels at Wockhardt in India are supporting the company's US generics business by working on non-infringing technologies, filing ANDAs and liaising with US regulatory bodies. Earlier this year, key officials handling corporate scientific affairs and intellectual property, were relocated from Wockhardt's Mumbai headquarters to the newly-established Wockhardt USA Inc.