While the US Food and Drug Administration (USFDA) has announced a voluntary recall of 14 lots of prescription ranitidine capsules manufactured by pharmaceutical major Sandoz over presence of human carcinogenic chemical N-nitrosodimethylamine (NDMA), the move is likely to have an impact on some of the Indian manufacturers of the medication, analysts say.
The Drugs Controller General of India also sounded a public health alert over the issue and directed the state regulators to verify the medicines with ranitidine and take appropriate measures for patient safety.
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Ranitidine is a commonly used heartburn drug which has been in the market for more than three decades. It is mainly sold over the counter. According to the USFDA statement, some drugs that contain ranitidine as the active ingredient are contaminated with NDMA, a substance that could cause cancer.
The USFDA and European health authorities are currently assessing the permissible levels of NDMA.
According to brokerage Prabhudas Liladhar, the bigger players in the drug are Dr Reddy’s, Strides, Perrigo, Aurobindo and Apotex. Some companies such as Granules have approvals to launch the drug but still haven’t.
Dr Reddy’s that manufactures the active pharmaceutical ingredient (API) and the final product has voluntarily stopped all global supplies of the drug. While the company does not sell it in the Indian market, it does supply the API for manufacturers such as GSK India. In the US market, Dr Reddy’s was selling the final product. Analysts say that Dr Reddy’s generates $10 million to $15 million of revenue from ranitidine generic in the US market.
The formulation is expected to have been manufactured at their Seveport plant with a third party API. Market concerns
Aurobindo too is expected to generate around $8 million to $10 million of revenue from the drug in the US. One will have to see the next steps Aurobindo takes and whether it would be similar to withdrawing the drug like it did for the sartan group of drugs used for blood pressure. Eventually Aurobindo received a warning letter from the USFDA for its Unit XI with the main issue being manufacturing of sartan drugs.Exposure of pharma company Strides and its recently listed API arm Solara is also what the street is concerned about. Ranitidine is one of the top 5 products for Strides in the US. It received approval for Ranitidineover-the-counter tablets early last year. At the time of approval Strides had around 30 percent market share in the Ranitidine prescription market. The market size for the OTC tablets was pegged at around $200 million at the time of Strides' approval. However, Strides is only selling the prescription and not the OTC version in the US. Strides has received an information request from the USFDA to provide test data in the next 30 days. The company says it is in the process of responding to it. The street would also like clarity on API supplies by Solara of ranitidine and whether they are supplying to larger players such as Sanofi for their non-US markets.