Strides Pharma Science fell 3.97% to Rs 313.35 after the company said that US drug regulator has requested all manufacturers to withdraw Ranitidine products from the US market.
Strides Pharma Science on 2 April 2020 informed that US Food and Drug Administration (USFDA) on 1 April 2020, has issued letters to all manufacturers of Ranitidine across dosage forms requesting withdrawal of all prescription (Rx) and over-the-counter (OTC) ranitidine drugs from the market immediately.This latest step is based on their ongoing investigation of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine medications. The USFDA's statement, though, points out, we didn't observe unacceptable levels of NDMA in many of the samples that we tested, but results indicate that NDMA levels may increase over time or when exposed to high temperatures.
Ranitidine is an Rx and OTC drug used as an H2 (histamine-2) receptor blocker, which decreases the amount of acid created by the stomach. Strides has approval for Rx and OTC Ranitidine tablets for the US market, and it currently commercializes only the Rx product in the US.
In September 2019, following a citizen petition filed in the US by an online pharmacy, the USFDA learned that some ranitidine medications contain NDMA at low levels and FDA issued a statement alerting patients of NDMA found in samples of Ranitidine. The agency, then, did not announce any intention to recall the product and requested all Ranitidine manufacturers to conduct laboratory testing to examine levels of NDMA in Ranitidine, recommending the use of an LC-HRMS testing protocol. Consequently, Strides submitted the requested data to the USFDA and until test results were available, Strides voluntarily suspended the sales of ranitidine Rx tablets in September 2019.
In November 2019, the USFDA had announced the laboratory testing and analysis of ranitidine and advised the acceptable NDMA limits. In the summary of test results provided by USFDA, Strides'' ranitidine tablets were found to be within the acceptable limits for NDMA. Subsequently, the company had announced the re-launch of ranitidine tablets in the US market.
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Ranitidine is one of the top 5 products for Strides in the US market, and at this point of time, the company is estimating the full impact on the revenues due to the USFDA requested withdrawal of Ranitidine.
In FY20, Strides Pharma's US revenues stood at approximately US$ 180 million for 9M FY20 as against the outlook of $220-$240 million for FY20 ($150 million in FY19).
Despite the discontinuation of Ranitidine, Strides remains confident of its US Business and continues to maintain a positive growth outlook for FY21. As of date, the company has 123 cumulative ANDA filings with USFDA of which 85 ANDAs have been approved already, and only 35+ products are commercialized in the US. The company also has a pipeline of 38 products pending approval with the USFDA. The future growth in the US will primarily be driven through improved market shares and healthy order book for our commercialized products, and a robust pipeline of new launches in the market, the drug maker said in the filing.
On a consolidated basis, the drug maker's net profit slumped 68% to Rs 93.89 crore despite a 28.5% rise in net sales to Rs 732.44 crore in Q3 December 2019 over Q3 December 2018.
Strides Pharma Science is a global pharmaceutical company. It focuses on difficult to manufacture products that are sold in over 100 countries.
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