European regulator lifts drug export ban from Ranbaxy Laboratories' Toansa plant - Angel Broking

"European health regulator today lifted suspension imposed on export of drugs produced at Ranbaxy Laboratories' Toansa plant to the EU stating medicines produced at the site posed no risk to public health despite having a number of manufacturing deficiencies.

In a statement, the European Medicines Agency (EMA) said European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at the Toansa plant. There were a number of GMP deficiencies at the concerned site; assessment of all available information has reassured European regulators that there has been no risk to public health from these deficiencies. As a consequence, the EU authorities will reinstate the GMP certificate which was suspended in January 2014. The certificate will be re-entered into EudraGMDP, the EU database that contains GMP certificates, EMA added.

Ranbaxy had voluntarily suspended exports from the Toansa plant to the EU in January 2014 after US Food and Drug Administration (USFDA) had banned the company from exporting drugs produced at the plant to be sold in the US. The assessment of the Toansa facility by EMA followed an inspection by the USFDA, which revealed areas of non-compliance with GMP at the site.

The Toansa site had been supplying APIs (active pharmaceutical ingredients) for four centrally authorised medicines – Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide), and Nevirapine Teva (nevirapine) – and several non-centrally authorised medicines. Two GMP certificates have been issued by EU authorities - one covering APIs that are used in medicines authorised in the EU and a second certificate covering an intermediate of a finished medicine authorised in the EU. Suspension of export to EU from the company's other plant at Dewas in Madhya Pradesh, however, remains. The news is positive for the company, and has come after a lot of negative news flows on the regulatory fronts. We remain neutral on the stock."

Shares of RANBAXY LABORATORIES LTD. was last trading in BSE at Rs.447 as compared to the previous close of Rs. 443.9. The total number of shares traded during the day was 463633 in over 12678 trades.

The stock hit an intraday high of Rs. 464.95 and intraday low of 445.25. The net turnover during the day was Rs. 209701745.

Source : Equity Bulls

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