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Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL:
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Statement “non compliance GMP”. Officina Farmaceutica: Parabolic Drugs Limited – INDIA (30/07/2015)
Following the inspection, conducted by the inspectorate Italian, under the program of inspections of the EDQM, at the Indian site in question, the same was not “in compliance” with the GMP.
It calls on companies to verify, with urgency, if the medicines containing the following active substances / intermediate production Dicloxacillin SODIUM, amoxicillin trihydrate, PIVAMPICILLIN, Flucloxacillin SODIUM, SODIUM cloxacillin, AMPICILLIN trihydrate, AMPICILLIN ANHYDROUS, Bacampicillin HYDROCHLORIDE authorized for the Italian market and / or products for export, showing this as a possible supplier of active / intermediate Officina Farmaceutica: PARABOLIC DRUGS LIMITED, PDL-2 – Plot No. 45, Industrial Area, Phase II, Panchkula District of Haryana, 134113 , INDIA .
The communication must be sent only by all companies Holders of marketing authorizations or Officine pharmaceutical manufacturers of medicines containing these materials pharmacologically active / production intermediates produced at…
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