Granules: No data integrity issues, to reply to Portugal regulator by January 17

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Hyderabad | Published: January 10, 2017 6:54:47 AM

Pharmaceutical company Granules India shares plunged 13% after the company received an inspection report with 11 observations from the Portuguese drug regulator.

INFARMED Portugal had conducted a renewal inspection on the company's Gagilapur facility in Telangana that manufactures pharmaceutical formulation intermediates and finished dosages. (Reuters)INFARMED Portugal had conducted a renewal inspection on the company?s Gagilapur facility in Telangana that manufactures pharmaceutical formulation intermediates and finished dosages. (Reuters)

Pharmaceutical company Granules India shares plunged 13% after the company received an inspection report with 11 observations from the Portuguese drug regulator.

INFARMED (InstitutoNacional da Farmacia E Do Medicamento), Portugal had conducted a renewal inspection on the company’s Gagilapur facility in Telangana that manufactures pharmaceutical formulation intermediates and finished dosages. The company said it had initiated steps to address observations of the inspection agency and will submit its response with a corrective and preventive action plan within stipulated time.

INFARMED had issued observations on January 3 after it detected non-conformities in good manufacturing practices (GMPs) related to granulation and primary packaging of tablets in batches of drugs related to paracetamol and metformin supplied to Mylan, Bluepharma and Sandoz. Portugal, member of European Union, banned the concerned batches from sale in Europe.

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In an interview to a television channel, C Krishna Prasad, MD, Granules India said there are no data integrity or falsification issues and that they expect to send a report to the Portuguese authority by January 17. The company’s previous share price was at R112.40 on BSE and closed at R101.20 following the regulator reports. Prasad said quality remains the focus of the company and they were certainly not expecting 11 observations. The observations could result into an import alert which can have revenue impact.

“There is absolutely no data integrity falsification issues and again no repetition. These are fresh issues which are normally not taken up by agencies. So, very interesting observations they are and we have started remediation measures. Most of them in the last two days have been completed and in the next five days we expect to complete the entire thing and by January 17 we expect to send the report to the Portuguese authority,” he said.

“We have a feeling they are going to come for a quick re-visit, first week of February and meanwhile, they are not clear about our GMP licence. However, we have taken a call and stopped manufacturing. In Portugal we sell about R1.5 crore worth drug but in Europe we sell about R113 crore which is about R28 crore per quarter and which is less than 8% of our total revenues,” he added.

Meanwhile, Granules’ OmniChem facility, a 50:50 joint venture company of Granules and Japan-based Ajinimoto OmniChem, in Vizag, last month received seven observations from USFDA. Granules said it has responded to those observations within the stipulated time period. The facility currently manufactures API intermediates.

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