Strides Pharma Sciences Ltd Destroyed Evidence BENGALURU, INDIA – As reported in online news articles published by reuters.com and bloomberg.com , the FDA recently reported that India-based Strides Pharma Sciences Ltd attempted to destroy quality control documents, raising concerns about the safety of the pharmaceutical company’s drugs that are sold in the United States.
NEW DELHI: Strides Pharma Science on Friday said it has relaunched Ranitidine tablets used in ulcer treatment in the US as the level of NDMA (N … We have an overwhelming focus on an efficient R&D to derive on-time approvals, market launches, and sustain growth momentum.

They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. Ranitidine recall 2020: FDA asks for immediate withdrawal of all ranitidine drugs (such as Zantac) Updated Apr 01, 2020; Posted Apr 01, 2020 . The recall includes ranitidine hydrochloride capsules at 150 mg and 300 mg doses sold in 30, 60 and 500 count bottles. Photos are attached below.Glenmark is notifying its direct customers by mailing (UPS Overnight) a recall notification letter and is arranging for return of all recalled product. "Strides' Ranitidine tablets 300 mg were within the acceptable limits for NDMA of 96 nanograms per day or 0.32 ppm.Strides have now completed comprehensive testing of several of its batches available in the market and in stock meet the limits prescribed by the USFDA," it said.Basis the outcome, the company has decided to relaunch its product with immediate effect, it added. Anyone with an existing inventory of the product should quarantine the recalled lot immediately.Customers who purchased the impacted product directly from Glenmark and consumers can call Qualanex at 1-888-504-2012Call: 1-888-504-2012 Monday – Friday, 9:00 am – 5:00 pm, EST to arrange for product return.Consumers who have Ranitidine Tablets, USP subject to this recall should immediately discontinue use and consult with their physician or healthcare provider about treatment options.Consumers who would like to report any adverse reactions or quality problems experienced as a result of their use of this product, or have questions regarding the use of Ranitidine Tablets, USP can contact Glenmark Drug Safety by phone at Glenmark customer service center at 1-888-721- 7115, Monday thru Friday, 9:00 am – 6:00 pm, US EST, or e-mail at Write CSS OR LESS and hit save. Strides Pharma, Inc. The following NDCs of Ranitidine Tablets, USP, 150 mg and 300 mg, are included in this recall:The affected Ranitidine Tablets were distributed directly to Wholesalers, Distributors, Retailers and Repackagers nationwide.The 150mg products product are packaged in bottle packs of 60’s, 100’s and 500’s, whereas, the 300mg products are packaged in bottle packs of 30’s, 100’s and 250’s. Download form or call 1-800-332-1088 to request ... USP, 16 lots were manufactured by Glenmark Pharmaceuticals Ltd., Goa, India and 912 lots were manufactured by Strides Pharma Science Limited, Puducherry, India. To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall.Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

Strides have approvals for Ranitidine tablets USP 150 mg and 300 mg.Citing IQVIA MAT data, Strides said the US market for Ranitidine tablets 150 mg and 300 mg is around USD 76 million.The views expressed in comments published on newindianexpress.com are those of the comment writers alone. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.Glenmark’s Ranitidine Tablets 150 mg and 300 mg are manufactured at two approved manufacturing facilities.

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In addition, Denton Pharma and Northwind Pharmaceuticals also recalled … newindianexpress.com reserves the right to take any or all comments down at any time. By The …

US generics specializes in soft-gel capsules (SGC), oral solids, modified releases, topicals and liquids. The Ranitidine Tablets, USP, distributed by Glenmark are prescription oral products. As a further precautionary measure, Glenmark ceased distribution of its Ranitidine products in the United States while it continues its efforts to test and investigate in cooperation with the FDA.To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall. Glenmark Pharmaceutical Inc., USA (“Glenmark”) announced on 12/19 the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.The recalled lots of Ranitidine Tablets 150 mg and 300 mg, which are listed in Attachment B, are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. The series of recalls of ranitidine (also known as Zantac) and nizatidine products grew longer with three US Food and Drug Administration (FDA) announcements on Tuesday and Wednesday. For a full list of recalled medications, click here. CTRL + SPACE for auto-complete. Ranitidine Tablets 150 mg and 300 mg is a prescription oral product approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.Glenmark is committed to product and consumer safety.