The regulators said they were satisfied that corrective measures put in place by the company were sufficient to ensure products at the site will be in compliance with good manufacturing practices and they will reinstate the GMP certificate that was suspended in January.
In what comes as a positive development in the otherwise troubled Ranbaxy , the European drug regulator has said that drugs from the pharma company's Toansa unit are fine.
EMA in a statement said, while they found number of GMP deficiencies in Toansa, but in their assessment they were assured that there was no risk to public health from these deficiencies. European regulator also said the corrective measures put in place by Ranbaxy to ensure GMP-compliance at the Toansa were satisfactory. And hence the regulators will reinstate Toansa's GMP certificate, which was suspended in January 2014 after USFDA's import ban on the plant.
The Indian regulator had also withdrawn the Written Confirmation for the plant which meant Ranbaxy could not export from Toansa. But this re-instatement from EMA means Ranbaxy could start supplies soon. Toansa site had been supplying APIs for four centrally authorised medicines – Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide), and Nevirapine Teva (nevirapine) – and several non-centrally authorised medicines.
Following key observations of GMP violations in the USFDA audit, EMA along with regulators from Germany, Ireland, UK, Switzerland & Australia undertook unannounced audits. The regulators however said they found no evidence of drugs manufactured using raw materials from Toansa that was of unacceptable quality.
Combined audits are also planned for Ranbaxy's Dewas unit and possibly will happen this month. Ranbaxy had voluntarily suspended supplies from this plant. EMA says they still need to keep Toansa site under close supervision and will collaborate with India & other international regulatory authorities for supervision.
Although the bigger concern on the USFDA ban still continues, but since international regulators share inspection and audit data, this positive signal from European regulator could in some way help USFDA resolution process forward as well. But definitely a positive even for Sun Pharma which as it proceeds with Ranbaxy acquisition and has the huge burden of reviving Ranbaxy's troubled plants.
Ranbaxy Labs stock price
On June 05, 2014, Ranbaxy Laboratories closed at Rs 443.90, up Rs 1.10, or 0.25 percent. The 52-week high of the share was Rs 505.00 and the 52-week low was Rs 253.95.
The latest book value of the company is Rs 3.41 per share. At current value, the price-to-book value of the company was 130.18.
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