Last week the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued the Indian manufacturer a statement of non-compliance with GMP for its Waluj oral solid dose facility in Aurangabad, India, temporarily halting production.
Sirjiwan Singh, Managing Director at Wockhardt UK told Outsourcing-Pharma.com that he is confident the problems at the facility – which plays the role of the contract manufacturer for Wockhardt’s UK and US subsidiaries – will be rectified within three months, with a re-audit by the MHRA scheduled for September.
“As far as this goes, we have answered to all the queries raised by the MHRA in the statement,” he said. “No critical observations were made [by the MHRA], only major observations of which we have addressed.”
The plant was inspected by the MHRA in March and a number of manufacturing issues that did not meet with Good Manufacturing Practice (GMP) guidelines were identified, including “a risk of cross-contamination and evidence of data falsification in relation to staff training records that were rewritten without authorisation,” an MHRA spokesperson told this publication.
The visit coincided with an inspection by the US Food and Drug Administration (FDA) who issued the manufacturer with an Import Alert in May, banning products made at the site from being imported into the US. The firm had received a 483 warning letter from the US regulators the month before.
Supply and Cost
Though the MHRA told us it is “currently assessing the implication that this has on the supply of medicines to patients in the UK,” Singh said only 5% of Wockhardt’s products originate from Waluj, with Wockhardt’s site in Wrexham, UK producing the bulk of its medicines (70%).
Furthermore, of the 15 products manufactured at the facility solely for Wockhardt UK and US, three have already been transferred to other facilities in India and the remaining ones are in the process of being moved, he added.
As for the costs associated with rectifying the facility and moving products, Singh said it did not lie with Wockhardt UK but rather with the Indian contract manufacturing division.
Following the FDA Import Alert, Habil Khorakiwala – Chairman of Wockhardt – told press in a conference call that end of year revenues could be affected by up to $100m.
Since last week’s MHRA announcement, shares in the company hit a 52-week low.