Wockhardt Ltd says state regulator lifts drug ban, shares soar

Apr 28 2014, 20:54 IST
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SummaryWockhardt said regulator revoked suspension on a combo drug used for treatment of pain.

Pharmaceuticals firm Wockhardt Ltd today said Himachal Pradesh drug regulator has revoked the suspension imposed on sale and manufacturing of a combination medicine used for treatment of pain.

"The State Drug Controller, Himachal Pradesh, has now revoked the suspension and accordingly the company will continue to manufacture, sell and distribute the fixed dose combination (FDC) of cicyclomine hydrochloride IP 10mg, tramadol hydrochloride IP 50mg and acetamenophen IP 325mg," Wockhardt said in a filing to the BSE.

Last week, the company had said Himachal Pradesh state drug controller has suspended the manufacture, sale or distribution of the said FDC medicine.

Wockhardt had said in order to revoke the suspension, it was filing an appeal before the state government.

Reacting to the news, shares of Wockhardt Ltd jumped 13.47 per cent on the BSE in the afternoon trade to Rs 733 per scrip.

India's Wockhardt says state regulator lifts drug ban

(Reuters) Indian generic drugmaker Wockhardt Ltd said on Monday the drug regulator of the northern Indian state of Himachal Pradesh has revoked a suspension it imposed on the manufacture and sale of a combination drug for pain treatment.

Wockhardt said last week the drug regulator suspended the manufacture, sale or distribution of fixed dose combination of Dicyclomine Hydrochloride IP 10mg, Tramadol Hydrochloride IP 50mg and Acetamenophen IP 325mg.

Navneet Marwah, Himachal Pradesh's drug regulator, said the suspension came into force on April 22 as he had some concerns about the "safety and efficacy" of the product, and sent a report to the Drug Controller General of India (DCGI).

The suspension was revoked on April 26, after the DCGI responded to Marwah saying it found no problems with the products' safety and efficacy, the state drug regulator told Reuters.

In a statement issued on Monday, Wockhardt said the state regulator has lifted the ban and it would continue to make and sell the product.

The company has not given any reason for the ban or its revocation, but when it disclosed the suspension on April 23, it said the product contributed less than 3 percent of the consolidated sales of the company in the financial year ended March 31.

A Wockhardt spokesman did not have immediate comment.

Wockhardt shares rose 8.5 percent to 703.10 rupees on Monday in a Mumbai market that was down 0.2 percent.

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