The British drug regulator Medicines and Healthcare products Regulatory Agency (MHRA) has cleared Wockhardt's Kadaiya facility at Daman, said chairman Habil Khorakiwala.
The British drug regulator Medicines and Healthcare products Regulatory Agency (MHRA) has cleared Wockhardt's Kadaiya facility at Daman, said chairman Habil Khorakiwala.
"This morning our Kadaiya facility at Daman has been cleared by the UK MHRA. It stays in full compliance," Khorakiwala told reporters.
In October 2013, MHRA had imposed restrictions on import of medicines made at the Mumbai-headquartered company's manufacturing plant at Kadaiya over non-compliance issue. The agency, however, later eased restrictions to an extent allowing the company to supply most of the products manufactured at the said facility to the UK market. The net impact on the annualised consolidated revenue was estimated to be around 1 million pound, out of the total annual consolidated revenue of approximately 18 million pound from the said facility.
Khorakiwala said the company has received the US Food and Drug Administration (FDA) Form 483 with some observations in relation to products manufactured prior to execution and implementation of good manufacturing practice (GMP) remediation programme, after the US regulator conducted a 10-days inspection at Chikalthana. The recent inspection was a continuation of the US agency's last visit to the plant.
"After a 10-days of intensive inspection, US FDA has found the quality system at manufacturing as overall satisfactory. They want a proper review of the previous drugs. We will respond to their queries within the normal 15 days time," he said.
The chairman, however, could not offer any expected timeline on when the import ban for Chikalthana would be lifted. The companies' other facilities, including Shendra, have also been offered for inspection. Khorakiwala further said that once Chikalthana gets a clearance, the facility can recover about 50-60% of its business.
Shares of the company on BSE touched a 52-week high of Rs 1,980 before trimming gains to end at Rs 1,909.80 a piece, up 1.67% from the previous close.
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