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UK regulator withdraws GMP certificate for Wockhardt's Kadiya facility
Our Bureau, Mumbai | Tuesday, October 22, 2013, 13:40 Hrs  [IST]

Wockhardt, a Rs.5,600 crore pharma giant, has received major setback as the Medicines and Healthcare Products Regulatory Agency, United Kingdom (UK MHRA) decided to withdraw the previously issued GMP Certificate to the Company’s manufacturing facility situated at Survey No. 106/4-5-7, Kadaiya, Nani Daman and will be issuing a restricted GMP Certificate to the site along with a statement of noncompliance for the said site. Wockhardt scrip declined by over Rs.10 to Rs.467.85 on BSE in the morning session today.

In order to avoid market shortage of medically essential products, the GMP certificate will be conditioned to permit continued manufacturing and QC testing of 'critical' products in situations where it has been agreed by the national competent authority or EMA (as appropriate) that there is no feasible alternative in the market concerned. The scope of the statement of non-compliance is therefore limited to medicinal products considered noncritical to public health. Accordingly, the Company shall be able to manufacture and supply from the said facility certain medicinal products critical to public health.

The impact of the same on existing business will only be known once the company receives further communication from UK MHRA. The company doesn't manufacture any products for the US market at the said manufacturing facility.

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