Jubilant Life Sciences tumbles after receiving warning letter from USFDA

Jubilant Life Sciences tumbled 9.82% to Rs 126.25 at 11:49 IST on BSE after the firm said that one of its manufacturing facilities, Jubilant HollisterStier, LLC in the United States has been issued a warning letter by US Food and Drug Administration.

The announcement was made during trading hours today, 5 December 2013.

Meanwhile, the S&P BSE Sensex was up 331.66 points or 1.6% at 21,040.37.

On BSE, 4.14 lakh shares were traded in the counter as against average daily volume of 1.51 lakh shares in the past one quarter.

The stock hit a high of Rs 145.80 and a low of Rs 126.05 so far during the day.

 

The stock had outperformed the market over the past one month till 4 December 2013, surging 37.86% compared with the Sensex's 2.5% fall. The scrip had also outperformed the market in the past one quarter, galloping 104.38% as against Sensex's 11.53% surge.

Jubilant Life Sciences (JLL) said that as required by the United States Food and Drug Administration (USFDA), JHS-Spokane will respond to the warning letter from USFDA on or before 12 December 2013. The response will identify corrective actions already been completed as well as some pending corrective actions to ensure on-going cGMP compliance, the company said in a statement.

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

JLL said it expects that the on-going manufacturing, distribution and sale of products from this facility will not be impacted as the warning letter 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 USFDA to bring resolution to this matter, the company said.

During first half of FY 2014, the contract manufacturing operations at JHS-Spokane contributed 7% to consolidated sales and 4% to consolidated EBITDA of JLL, the company said in a statement.

Jubilant Life Sciences reported a consolidated net loss of Rs 80.58 crore in Q2 September 2013 as against net profit of Rs 152 crore in Q2 September 2012. Net sales rose 17.8% to Rs 1424.30 crore in Q2 September 2013 over Q2 September 2012.

Jubilant Life Sciences is a global pharmaceutical and life sciences company engaged in manufacture and supply of APIs, generics, specialty pharmaceuticals and life science ingredients. It also provides services in contract manufacturing and drug discovery and development.

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