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    NEWS

    DRUGS & DEVELOPMENTS

    MARKET INTEL by PharmaCompass

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    GSK was warned repeatedly about Zantac impurity but played down risks

    FIERCE PHARMA

    Health Canada Issues Recall of Apotex`s Apo-Acyclovir Tablets

    HEALTH CANADA

    Advancing nitrosamines analysis with gas chromatography

    EUROPEANPHARMACEUTICALREVIEW

    Majority of metformin drugs have acceptable nitrosamine levels, finds study

    EUROPEANPHARMACEUTICALREVIEW

    Advisory - Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurity

    NEWSWIRE

    NDMA issue persists as 2 more companies recall Nizatidine-based products

    KOREABIOMED

    Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets

    FDA

    Viona Pharma Issues Voluntary Nationwide Recall of Metformin HCl ER Tablets for NDMA Impurity

    FDA

    Health Canada Pharmascience Inc.Recalls of PMS-Ranitidine 150mg

    HEALTH CANADA

    Indian drug firms recall various products in US market

    TRIBUNEINDIA

    Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg

    FDA

    Marksans Pharma Issues Expansion of Voluntary Nationwide Recall of Metformin HCL ER Tablets

    FDA

    Sun Pharmaceutical Issues Recall of RIOMETER™ Due to NDMA content higher than ADI limit

    FDA

    Popular diabetes drug recalled months after FDA issued cancer risk warning

    SLASHGEAR

    Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension)

    FDA

    Sun Pharma Issues Voluntary Nationwide Recall of RIOMETER

    BIOSPACE

    FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines

    FDA

    Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets

    FDA

    Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets

    FDA

    Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride

    FDA

    Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets

    FDA

    Amneal Pharmaceuticals Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level.

    FDA

    USFDA for recall of diabetes drug Metformin after tests find high levels of carcinogen

    THEHINDU

    Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)

    FDA

    Regulator Asks 5 Firms To Recall Diabetes Drug Over Carcinogen Concerns

    NDTV

    Amneal Pharmaceuticals,Issues Voluntary Nationwide Recall of Nizatidine Oral Solution

    FDA

    Amneal Pharmaceuticals Issues Voluntary Nationwide Recall of Nizatidine Oral Solution

    FDA

    Aurobindo Pharma faces class action suit in US for concealing facts

    BUSINESS-STANDARD

    Update on nitrosamines in EU medicines

    EMA

    American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets

    FDA

    Certain Metformin diabetes drugs recalled due to the presence of NDMA

    BUSINESSINSIDER

    NDMA in Metformin: FDA Finds Low Levels in Only 2 of 10 Tested Products

    RAPS

    More generic Zantac recalled as contamination concerns build

    FIERCE PHARMA

    Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsule

    PR NEWSWIRE

    Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsule

    PR NEWSWIRE

    Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsule

    PR NEWSWIRE

    TGA investigation - potential contamination with N-nitrosodimethylamine

    TGA

    After Zantac scare, FDA targets generic metformin for carcinogen tests

    FIERCE PHARMA

    HSA Recalls Three out of 46 Metformin Medicines

    HSA

    Enforcement Report - Week of December 4, 2019

    FDA

    Alembic Pharma expects better growth for pharma industry going ahead

    PHARMABIZ

    Solara Active Pharma Sciences update on Ranitidine HCL & Nizatidine API

    BUSINESS-STANDARD

    Contamination Potential Leads UK to Fifth Recall of Ranitidine Drugs

    RAPS

    Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution

    FDA

    Golden State Medical Supply Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride

    FDA

    Mylan plant knocked for sloppy controls over valsartan API

    FIERCE BIOTCH

    Amneal Pharmaceuticals, Issues Voluntary Nationwide Recall of Ranitidine Tablets

    FDA

    A tiny pharmacy is identifying big problems with common drugs, including Zantac

    THE WASHINGTON POST

    Strides Pharma relaunches Ranitidine tablets in US

    ECONOMIC TIMES

    Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall

    FDA

    Solara Active Pharma Sciences update on Ranitidine Hydrochloride & Nizatidine API

    BUSINESS-STANDARD

    US FDA finds acceptable NDMA limits in Strides Pharma ranitidine batches

    PHARMABIZ

    Statement on new testing results, including low levels of impurities in ranitidine drugs

    FDA

    Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP)

    FDA

    FDA investigating whether Zantac causes carcinogens to form in users

    REUTERS

    Strides Pharma`s ranitidine tablets safe as per TGA tests

    PHARMABIZ

    Perrigo Company Issues Voluntary Worldwide Recall of Ranitidine

    FDA

    Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.

    FDA

    Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products

    FDA

    Dr Reddy`s recalls all its ranitidine products in US

    ECONOMICTIMES

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