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Cancer Risk; DRAP Advises Halt in Ranitidine Production

Food and Drug Regulatory Authority of the US made an announcement on September 13th, which alerted the pharmaceutical industry and public alike. FDA had determined that N-nitrosodimethylamine (NDMA) could be produced during the manufacturing of ranitidine drugs. Ranitidine (commonly marketed under ‘Zantac’) is a common heartburn medicine/antacid, which is easily available over the counter.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

The industry was roiled last year when it learned that NDMA and two other suspected carcinogens could form during the manufacturing of the commonly used “sartan” blood pressure meds valsartan, losartan and irbesartan.

But the industry only just learned that the same kind of production phenomenon also applied to ranitidine-containing drugs. Regulators and the industry were tipped off to the problem by online pharmacy Valisure, which discovered it during its own testing. The company then filed a Citizen Petition calling on the FDA to seek a market recall of all of the drugs and establish standards for testing and manufacturing.

Several pharma manufacturers have begun to voluntarily recall all Ranitidine drugs. Concerned countries are now placing ban on the import and distribution of these drugs as well.

Drug Regulatory Authority of Pakistan (DRAP) has issued notice to pharmaceutical companies across the countries to halt Ranitidine drugs production and to recall all such products already on the market.

The DRAP letter stated: FDA and Euro­pean Medicines Agency (EMA) are evaluating the risk associated with low levels of NDMA in Rani­tidine. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Drap is closely working with international regulatory agencies to monitor the outcome of the investigations. However, in the greater public interest and in order to protect patients from probable risk associated with the detection of low levels of NDMA in Ranitidine, it is advised to suspend production for all dosage forms of Ranitidine-containing drugs till further orders; the stoppage of the release/distribution of all dosage forms of Ranitidine-containing drugs till further orders; and the stoppage of the sale/supply/utilisation of all dosage-forms of Ranitidine-containing drugs till further orders. Furthermore, it is requested to initiate the recall of the medicine available in sale outlets/distributors/hospitals/healthcare facilities.

Following are the brand names by which ranitidine is being marketed in Pakistan:

Brand NameManufacturer/Mnf. Representative
ACEDONILGLOBAL PHARMACEUTICALS
ACIDRANVALOR PHARMACEUTICALS
ALTALALSON PHARMACEUTICALS
ANZOLINDUS PHARMA (PVT) LTD.
BIODINE TABSALKEMY PHARMACEUTICAL LABORATORIES (PRIVATE) LTD.
CHASESHROOQ PHARMACEUTICALS
DANITNMIRACLE PHARMACEUTICALS(PVT) LTD
DARTMEDICAIDS PAKISTAN (PVT) LTD.
DEGUSTHYGEIA PHARMACEUTICALS
DINETACUNEXO LABS (PVT) LTD.
DINOLIVEOLIVE PHARMACEUTICALS
DUOTECASKARI PHARMACEUTICALS.
FESNIDINEALFALAH PHARMA (PVT) LTD.
FOZABPEARL & PEARL
GERTOCALMNOBLE PHARMA
GLAMETSPENCER PHARMA
H2 RECZAFA PHARMACEUTICAL LABORATORIES (PVT) LTD.
HEALALSERLISKO PAKISTAN (PVT) LTD
KANTACDRUG PHARM (PVT) LTD.
LOMADRYLMEEZAB INTERNATIONAL
MARIQUINELISKO PAKISTAN (PVT) LTD
MONOCIDWEBROS PHARMACEUTICALS
NAZDACFYNK PHARMACEUTICALS
NIPODURA.J. & COMPANY.
NITIDDANAS PHARMACEUTICALS (PVT) LTD
NITISAFSAAAF PHARMACEUTICALS
NOULCELOWITT PHARMACEUTICALS (PVT) LTD
NULCERBOSCH PHARMACEUTICALS (PVT) LTD.
OBATIDINEOBSONS PHARMACEUTICALS
PEPTACMASS PHARMA (PRIVATE) LIMITED
PEPTICURENABIQASIM INDUSTRIES (PVT) LTD.
PEPTINILWILSONS PHARMACEUTICALS
PURODCAYLEX PHARMACEUTICALS (PVT) LTD.
PYRADGENOME PHARMACEUTICALS (PVT) LTD
RADICONMEDISURE LABORATORIES PAKISTAN (PVT.) LTD.
RAMATBLOOM PHARMACEUTICALS (PVT) LTD.
RAMED-ACRAAZEE THERAPUTICS (PVT) LTD.
RANAXSTANDPHARM PAKISTAN (PVT) LTD.
RANEXINAKSON PHARMACEUTICALS (PVT) LTD.
RANISiam Pharmaceuticals
RANIDINFEROZSONS LABORATOIES LTD.
RANIGARDVEGA PHARMACEUTICALS LTD.
RANILOCORTA LABS. (PVT) LTD.
RANIPEPDAVIS PHARMACEUTICAL LABORATORIES
RANISCOTSCOTMANN PHARMACEUTICALS
RANISONLIFE LINE PHARMACEUTICALS (PVT.) LTD.
RANIZANMEDIZAN LABS (PVT) LTD
RANTABJAWA PHARMACEUTICALS(PVT) LTD.
RANTACSAPIENT PHARMA
RANTIDCIBEX (PRIVATE) LIMITED
RANTINMACTER INTERNATIONAL (PVT) LTD.
RANULCIDMERCK PRIVATE LTD.
RATACPARAMOUNT PHARMACEUTICALS
RATIDINE TABLETGRAY`S PHARMACEUTICALS
RELIANCEMEGA PHARMACEUTICALS (PVT) LTD
RENACIDDRUGS INN PAKISTAN
RENATAPLATINUM PHARMACEUTICALS (PVT.) LTD.
RENATILGOODMAN LABORATORIES
RENERAMEDERA PHARMACEUTICALS (PVT) LTD.
RENILOCORTA LABS. (PVT) LTD.
RENOXIDAXIS PHARMACEUTICALS
RESOTACRASCO PHARMA
REXOTIDEREX PHARMACEUTICALS PAKISTAN
RINAIZ-JANS PHARMACEUTICAL (PVT) LTD.
RIOMACQUINS INTERNATIONAL
RITADINECHAS. A. MENDOZA
STOMACIDWERRICK PHARMACEUTICALS
TAGNAPANACEA PHARMACEUTICALS
TATIDINEDOSACO LABORATORIES
TIOBINEGRAY`S PHARMACEUTICALS
ULCEMEDMEDICEENA PHARMA (PVT) LTD.
ULCENORFLOW PHARMACEUTICALS (PVT) LTD.
ULCER OFFUNIPHARMA (PVT) LTD.
ULCERIDMEDICRAFT PHARMACEUTICALS (PVT) LTD.
ULSFREEZESION PHARMACEUTICAL (PVT) LTD
XETACXENON PHARMACEUTICALS (PVT) LTD.
XETRONHIGH – Q INTERNATIONAL
ZANIATEMEDIATE PHARMACEUTICALS (PVT) LTD
ZANTACGLAXOSMITHKLINE
ZENITDR. RAZA PHARMA (PRIVATE) LIMITED
ZOMTICALLIANCE PHARMACEUTICALS (PVT) LTD.
September 25, 2019

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