USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from list of excepted products from import

Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.

Published On 2022-07-14 10:39 GMT   |   Update On 2023-10-13 09:56 GMT
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NoidaJubilant Pharmova Limited's wholly owned subsidiary Jubilant Pharma Limited, has announced that its subsidiary Jubilant Generics Limited (JGL) has received a communication from the USFDA through which the latter intimated that it has decided to remove olanzapine orally disintegrating tablets, spironolactone tablets, and valsartan tablets from the list of excepted products from the Import Alert at the Roorkee facility of JGL.

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The USFDA mentioned its review of the product supply situation in the market and company's compliance status as the reasons for this decision. The current revenue from these three products is less than 1% of the consolidated revenues of the Company.

Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.

Read also: Jubilant Pharma arm to raise Rs 3,186 crore loan from Standard Chartered Bank to repay debt

Jubilant Pharma Limited (JPL), a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations through five manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.

Read also: Jubilant to double US injectable capacity at cost of Rs 1498 crore

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