Another successful FDA inspection at Alpex Pharma SA

On May 2017 Alpex Pharma has successfully passed a GMP inspection by US FDA and the outcome once more was satisfactory....

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Alpex successfully inspected and approved by FDA for a weight loss ODT (Orally Disintegrating Tablets).

Mezzovico, Switzerland February 28, 2011 – Alpex Pharma SA a Swiss Drug Delivery company and manufacturer of pharmaceutical solid dosage forms located in Mezzovico, recently got through a successful Pre-Approval Inspection by the US Food and Drug Administration (FDA) for the New Drug Application (NDA) of a weight loss Orally Disintegrating Tablets formulation. This represents an important recognition in Alpex’s continuous quality improvement and in Alpex’s patent technology for the rapid dissolving solid dosage forms.

Orally Disintegrating Tablets (ODT) technology is developed by Alpex Pharma SA (formerly Élan Pharma) in its laboratories located in Mezzovico, Switzerland.

This patent protected technology is able to formulate tablets which could disintegrate in the oral cavity, when in contact with saliva, releasing the active pharmaceutical ingredient (API).

The ODT presentation could be advantageous in comparison with other dosage forms because the API is released from the tablet directly into oral cavity; the API is solubilised / suspended into saliva and swelled, no water is needed for administration of tablets; avoiding swallowing of solids and facilitating ingestion in people with swallowing difficulties. The tablets could be coloured, flavoured, taste masked embossed, when necessary to improve patients compliance. Tablets are quite robust and could be packed in several presentations, including blisters, bottles, strips, etc.

Mr. Shahbaz Ardalan, Managing Director of Alpex Pharma SA commented this event: “The positive results of the Pre Approval Inspection, is the confirmation of the long term policy of our company and engagement to endorse quality and professionalism at the highest levels“.

Alpex Pharma SA was established in 1985 and develops and manufactures effervescent tablets, ODT and Extended Release dosage forms.

The Company is at present approved by major health authorities such as Swissmedic, EMEA, FDA, etc. and is commercializing its products worldwide.

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