Jubilant Life Sciences’ arm receives WL from USFDA for its manufacturing facilities

Jubilant Pharmova Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 530019 | NSE: JUBLPHARMA

05 Dec 2013 Evaluate

Jubilant Life Sciences ’one of its manufacturing facilities, Jubilant HollisterStier, LLC (JHS) located at Spokane, Washington State, US has been issued a Warning Letter (WL) by US Food and Drug Administration (FDA).

As required by FDA, JHS-Spokane will respond to this WL on or before December 12, 2013. The response will identify corrective actions already been completed as well as some pending corrective actions to ensure on-going cGMP compliance.

FDA specified in the WL that until all corrections have been completed and that they have confirmed correction of the violations and firm compliance to cGMPs, FDA may withhold approval of new applications or supplements listing JHS-Spokane as the drug product manufacturer.

The company expects that the on-going manufacturing, distribution and sale of products from this facility will not be impacted as the WL will affect new approvals only. JHS-Spokane is committed to implementing the necessary corrective actions required to address the FDA concerns, and will work closely with the FDA to bring resolution to this matter.

During 1HFY14, the contract manufacturing operations at JHS-Spokane contributed 7% to consolidated sales and 4% to consolidated EBITDA of JLL.

Jubilant Life Sciences is a global Pharmaceutical and Life Sciences Company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Life Science Ingredients. As on September 30, 2013, Jubilant Life Sciences had a total of 676 filings for formulations of which 218 have been approved in various regions of the world. This includes 58 ANDAs filed in the US and 48 Dossier filings in Europe.

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