Non compliance at Parabolic drugs

Statement “non compliance GMP”. Officina Farmaceutica: Parabolic Drugs Limited – INDIA (30/07/2015)

http://www.agenziafarmaco.gov.it/it/content/statement-%E2%80%9Cnon-compliance-gmp%E2%80%9D-officina-farmaceutica-parabolic-drugs-limited-india-30072015

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 the Indian site in question.

DICLOXACILLIN SODIUM

Recall of batches already released
Each involved NCA should evaluate, following assessment conducted in conjunction with MAHs, if a recall of medicinal product is needed. Evaluation should take into account if there are alternative suppliers and potential risk of shortage. Given the nature of non-compliances, assessment should include a complete retest of all imported batches of active substance.

Prohibition of supply
Due to the nature of non compliances, prohibition of supply is recommended.

Suspension or voiding of CEP (action to be taken by EDQM)
Withdrawal of all CEPs is ongoing.

IT/NCR/API/2/2015

PARABOLIC DRUGS LIMITED

Haryana

India

134 113

35250

352501438098068508

2015-07-28

2015-07-28 16:41:08 GMT

Italian Medicines Agency

Report No : IT/NCR/API/2/2015

STATEMENT OF NON-COMPLIANCE WITH GMP

Exchange of information between National Competent Authorities (NCAs) of the EEA following the discovery of serious GMP non-compliance at a manufacturer (1)

Part 1

Issued following an inspection in accordance with : Art. 111(7) of Directive 2001/83/EC as amended The competent authority of Italy   confirms the following: The manufacturer : PARABOLIC DRUGS LIMITED Site address : PDL-2, Plot No. 45, Industrial Area, Phase II, Panchkula District, Haryana, 134 113, India

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