Strides Pharma tumbles on suspending sale of Ranitidine tabs in US

Strides Pharma Science slumped 6.07% to Rs 308.65 after the company suspended sales of ranitidine tablets in the US market until such time it has clarity of next steps as would be indicated by the USFDA.

Ranitidine is a medication which decreases stomach acid production. The US drug regulator reportedly found a cancer-causing impurity called N-nitrosodimethylanine (NDMA) in some products containing ranitidine.

On 25 September 2019, Strides Pharma received an information request from the US drug regulator to provide test data related to NDMA impurities in ranitidine tablets. The data is to be provided to the agency in 30 days.

While the company conducts the relevant tests mandated by the United States Food & Drug Administration (USFDA), it has suspended sales of ranitidine tablets in the US market until such time it has clarity of next steps as would be indicated by the USFDA.

The company predominantly sells ranitidine tablets in the US markets, and its front end sales globally for the product were about $9 million in H1FY2020.

In spite of this temporary suspension of the ranitidine supplies, the company retains its FY20 growth outlook for the US markets.

In a separate announcement during market hours today, 27 September 2019, Strides Pharma Science (Strides) announced that its step‐down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for solifenacin succinate tablets, 5 mg and 10 mg from USFDA. The product is a generic version of vesicare tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc.

According to IQVIA MAT data, the US market for solifenacin succinate tablets, 5 mg and 10 mg is approximately $820 million. The product will be manufactured at Alathur facility in Chennai and will be marketed by Strides Pharma Inc. in the US market.

The company has 102 cumulative ANDA filings with USFDA of which 66 ANDAs have been approved and 36 are pending approval.

Meanwhile, the S&P BSE Sensex was down 60.49 points or 0.16% to 38,929.25.

On the BSE, 1.77 lakh shares were traded in the counter so far compared with average daily volumes of 1.21 lakh shares in the past two weeks. The stock hit a high of Rs 332 so far during the day. The stock hit a 52-week high of Rs 550.4 on 22 Jan 2019.

The stock hit an intraday low of Rs 305, which is also a 52-week low for the scrip.

On a consolidated basis, the pharmaceutical company reported a net profit of Rs 6.73 crore in Q1 June 2019 over a net loss of Rs 2.18 crore in Q1 June 2018. Net sales rose 45.1% to Rs 685.80 crore in Q1 June 2019 over Q1 June 2018.

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