Wockhardt was founded by Dr. Habil Khorakiwala in the 1960s.[7] His father Fakhruddin T. Khorakiwala had acquired Worli Chemical Works[8] in 1959. This was incorporated as Wockhardt Pvt. Ltd., in 1973.[5] Wockhardt Ltd. was incorporated on 8 July 1999.[9] In the 1990s, Wockhardt gained market share with its painkiller Proxyvon (opioid tramadol + paracetamol) and blood pressure drugs (lisinopril, etc.). In 1995, it expanded into biotechnology, and subsequently started producing intravenous fluids.[10] In 1999, Dr. Reddy's joined the Indian Pharmaceutical Alliance as a founding member in an effort to promote the development of generic drugs in India.[11][12]
Wockhardt's acquisitions include Wallis Laboratory, UK (1998); Merind, India (1998); CP Pharmaceuticals, UK (2003); Espharma GmbH, Germany (2004); Dumex, India (2006); Pinewood Laboratory Ireland (2006); Morton Grove Pharmaceuticals, US (2007);[18] and Negma, France (2007).[5] Wockhardt's debt following the acquisitions was close to Rs 38 billion, and Habil Khorakiwala quit as managing director.[19]
The board of directors, on 31 March 2009 approved the appointments of Habil Khorakiwala's sons Murtaza Khorakiwala and Huzaifa Khorakiwala as managing director and executive director respectively.[20]
Wockhardt is known for producing cough syrup with the sedativepromethazine and the opiate codeine, used in the recreational street drug lean, which is sometimes referred to as "Wock", short for Wockhardt.[21]
Good Manufacturing Practice violations
Wockhardt received a FDA warning letter 25 November 2013 identifying significant violations of current good manufacturing practice for finished pharmaceuticals at the Chikalthana and Waluj facilities.[22]
A warning letter sent 18 July 2013 referring to an 18 March inspection of the Waluj facility, Aurangabad cited repeatedly delayed, denied or limited an FDA inspection. Citations included destruction of raw analytical data, destruction of analytical samples, lying by both the production head and vice-president of Manufacturing to the FDA Inspector.
Specific GMP violations included failure to prepare batch production records for drug products, attempts to hide manufacturing for the USA market from inspection, use of 'trial' analyses and 'official' analyses to attempt to hide failing or out of specification results, inability to demonstrate integrity of computer records, no audit system for computer records, faked training records for critical GMP activities, and inadequate washing and toilet facilities.[23]
