The Medicines and Healthcare Products Regulatory Agency (UKMHRA) will now issue a “restricted GMP certificate” to the facility, which means the unit will be allowed to produce only certain critical drugs to avoid a shortfall in the UK.
“The impact of the same on existing business will only be known once the company receives further communication from UKMHRA. The said facility contributes approximately £12 million (Rs 117 crore at current exchange rate) from the UK and EU markets to the consolidated annual revenues of the company,” said Wockhardt in a filing to the exchange, adding that the scope of the statement is limited to medicinal products considered non-critical to public health.
Wockhardt Chikalthana facility contributed $230 million (Rs 1,408 crore at current exchange rate) to total revenue in FY13 — the largest revenue generating facility in the company’s manufacturing portfolio.
Wockhardt shares closed down 5% at Rs 499.30 on the BSE.
A UKMHRA spokesperson told FE via email that the agency issued a statement of non-compliance against Chikalthana after recent inspections identified a number of manufacturing deficiencies.
“We are still assessing them (the manufacturing deficiencies) and we are not in a position to discuss them publicly as our investigation ongoing. We are currently assessing what medicines are affected and how this impacts patients in the UK,” the spokesperson said.
“Although the products have not been manufactured in line with the GMP requirements, there is no evidence of a safety risk to patients. We are working with the department of health to ensure that people have access to the medicines they need,” the spokesperson added.
The Chikalthana facility — Wockhardt’s oldest manufacturing plant — is spread over about 6 acres and is approved to produce APIs and formulations. The facility produces generic version of the blockbuster cardiac drug Toprol-XL which contributed to 12% of the company’s sales in the fourth quarter, according to the transcript of a conference call with analysts.
This is the second time Wockhardt has seen adverse action from the UK regulator. In July, the UKMHRA initiated a precautionary recall of 16 prescription medicines owing to manufacturing deficiencies identified at Wockhardt’s Waluj site.
The recall had followed an inspection in March which noted poor cleaning practices and defects in building ventilation systems and evidence of forged documents relating to staff training records.
Wockhardt, which has seven production sites in India, has also been caught in the crosshairs of the US Food and Drug Administration. The US health regulator placed Wockhardt’s Waluj facility under an “import alert” preventing entry of products manufactured at the plant in the country.
It had also issued a Form 483 to Wockhardt after an inspection conducted jointly with the UKMHRA in July. The form lists certain certain deficiencies observed by the investigator during inspection of the unit.
Wockhardt anticipated the Waluj ban to adversely impact its revenue to the tune of $100 million on an annual basis. In August, the company confirmed that it has appointed a third-party consultant, US based-Lachman GMP Consultant Inc USA, to review and advise on the GMP shortfalls of both units.