Carcinogen Alert – Ranitidine Under The Lens
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Ranitidine, also known as N-Nitrosodimethylanine which is the latest product of Pharmaffiliates. We are one of the largest manufacturer/supplier/exporter of reference standards in worldwide.
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When: April 23, 12:30 - 2pm Pacific
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The document discusses nitrosamine impurities, which are carcinogenic compounds that have been found in some generic drug substances and products. It notes that regulatory agencies announced the presence of specific nitrosamines like NDMA and NDEA in drugs like ARBs, pioglitazone, and ranitidine. The document then provides background on nitrosamines and how they can be generated during drug manufacturing through use of reagents, catalysts, solvents or raw materials containing amines or nitrites. It outlines sources of nitrosamine impurities and recommends ways to prevent their formation, such as avoiding use of amines with nitrosating agents, properly storing materials, cleaning equipment, and modifying processes.
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Introduction
The Regulatory agency announced that Nitrosamine impurities N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) are said to be present in generic drug substances and drug product, especially in angiotensin II receptor blockers (ARBs) and belongs to a family of analogue compounds referred to as the sartans. Further FDA and EMA investigation also led to the detection of these Nitrosamine impurities in Pioglitazone and low level of NDMA impurity found in Metformin.
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The U.S. Food and Drug Administration is investigating several potentially cancer-causing substances, called nitrosamines, recently found in some drugs, including those used to treat elevated blood pressure, heartburn, acid reflux, and diabetes. Some of these drugs from certain manufacturers – including angiotensin II receptor blockers (ARBs), Ranitidine, Nizatidine, and Metformin – have been recalled because of nitrosamine impurities. Most recently, the FDA announced that its testing showed levels of the nitrosamine N-Nitrosodimethylamine (NDMA) in some samples of the extended release (ER) formulation of the diabetes medicine Metformin that exceed the agency’s acceptable intake limit.
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Fresenius Medical Care North America recalled their Naturalyte and Granuflo Acid Concentrate products used in hemodialysis treatment due to the risk of inappropriate prescription leading to metabolic alkalosis in patients. Metabolic alkalosis poses serious health risks such as low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which could result in cardiopulmonary arrest or death if not treated properly. The recall involved liquid and powder acid concentrate products manufactured between January 2008 and June 2012.
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Pharmacy-driven Clinical Transformation
April 2009 Community Call
When integrated medication processes and automated cabinets are in place, pharmacists are enabled to practice more “clinical pharmacy”. Often this means getting pharmacists out of the basement and onto the floors where they are available to patients and their caregivers. One of pharmacy’s services is to promote a safe, effective, and economical list of preferred drugs. With well-designed EHR technology as a tool, pharmacists can proactively influence physicians to choose the “right” drug. They can also measure and report on compliance to formulary preferences. The goal of this session is to explore the options available and present experience with a program currently in place at one of our ecosystem sites.
This topic is both clinical and administrative in nature and will likely be useful to all pharmacy staff, clinical specialists involved in building/maintaining CPOE systems, physicians, nurses and others interested in pharmacy management, both from a clinical and fiscal perspective.
Please feel free to forward this invitation to any colleagues or associates who you believe would find this topic of interest or would like to participate in the discussion.
What: Pharmacy-driven Clinical Transformation
- Strategic Drug Selection
- What is it?
- Why do it?
- How can it be done?
- How is it measured?
- Who has done it?
- Transformation Working Group Update
- Review of status
- Open Project Updates
- OpenVista/GT.M Integration
- CCD/CCR collaboration
- Medsphere.org: Tip of the month
When: April 23, 12:30 - 2pm Pacific
Where: Dial-in: (888) 346-3950 // Participant Code: 1302465
Web conference: http://www.medsphere.com/infinite/
===
The community calls are listed on the Medsphere.org event calendar (http://medsphere.org/community-events/) and we will update each month's call as the agenda is solidified.
Details and Recording here: http://medsphere.org/blogs/events/2009/04/23/community-call-april-2009
Indian Pharmaceutical Monthly Update July 2022.pdf
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Fda recall of fresenius dialysis drugs granu flo and naturalyte 3 29-2012
GranuFlo and NaturaLyte, two drugs made by Fresenius Medical Care for use during kidney dialysis, were recalled by the FDA on March 29, 2012. This is a copy of the FDA recall notice. This was the most serious type of FDA recall, a Class I recall, which means that the drug is likely to cause serious injury or death if used.
GranuFlo and NaturaLyte were recalled after they were found to have a significant risk of causing cardiac problems, heart attacks, and sudden death.
It is possible that the time to file a NaturaLyte or GranuFlo lawsuit could end on March 29, 2014, or even on some earlier date. If you suffered serious cardiac injuries or a heart attack during or after dialysis, or if you lost a family member from cardiac problems during or after dialysis, and if you don't have a lawyer, you need to contact a law firm. The injuries or death may have been caused by GranuFlo or NaturaLyte, and you may be unaware of it. There are lawyers (such as myself) who will evaluate a potential lawsuit free-of-charge. If it appears that the injuries or death may have been linked to NaturaLyte or GranuFlo, lawyers such as myself pay the cost of getting the medical records to find out if those drugs were used. If you suffered injuries or lost a loved one due to cardiac problems during or after dialysis, and this occurred before March 29, 2012, you should consider contacting a law firm immediately. Time may be quickly running out for you to take action to collect a large amount of money damages.
Formulation and evalution of sustained release matrix tablets
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- 1. Carcinogen Alert Ranitidine Under The Lens
- 2. Ranitidine, sold under the brand name ZANTAC is an OTC drug that is widely prescribed medicine for its multiple implications worldwide. It is on the World Health Organisation’s ‘Model List of Essential Medicines’. It is estimated, only in In India, a host of companies including GalxoSmithKline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy’s, Sun Pharmaceuticals sell over 180 versions of the drug.
- 3. US Food and Drug Administration (FDA) has recently found “unacceptable” levels of probable cancer- causing impurity called “N-nitrosodimethylanine (NDMA) ”in the drug. The carcinogenic impurity N-nitrosodimethylanine (NDMA) has probably arisen due to some changes made in the manufacturing process of the drug Ranitidine.
- 4. The medicine watchdog and governing bodies throughout the world have been asking the pharmaceutical manufacturers to suspend the release, distribution, and supply of all dose forms of Ranitidine productsand also to recall the batches of the drug which are available in the market.
- 5. In India, Drug Controller General of India (DCGI) directed state drug regulators to ask pharmaceutical companies to check their products for the carcinogenic impurity N- nitrosodimethylanine (NDMA). To obtain high quality, and high purity Reference standard of N-nitrosodimethylanine (NDMA), the pharmaceutical manufacturers can conveniently join their association with one of the largest manufacturers/supplier/exporter of reference standards PHARMAFFILIATES.
- 6. Details of Ranitidine impurity NDMA and other related products which are available at Pharmaffiliates are tabulated below: S.No Product name Cas no Product Code 1 N-Nitrosodimethylamine (NDMA) 62-75-9 PA PST 010435 2 1-Nitrosopyrrolidine (NYPL) 930-55-2 PA PST 010355 3 N-Nitrosomorpholine (NMOR) 59-89-2 PA PST 010380 4 Molsidomine - Impurity B 59-89-2 PA 13 49020 5 N-Nitrosodipropylamine (NDPA) 621-64-7 PA PST 010445 6 N-Nitrosopiperidine (NPIP) 100-75-4 PA PST 010350 7 N-Ethyl-N-nitroso-2-propanamine (N-Nitrosoisopropylethylamine) (NIEA) 16339-04-1 PA 27 02198 8 N-Nitrosodiethylamine (NDEA) 55-18-5 PA PST 010430 (PA 27 00355) 9 N-Nitrosodiisopropylamine (NDIPA) 601-77-4 PA PST 010615 10 N-Ethyl-N-nitroso-2-propanamine (NEIA) 16339-04-1 PA 27 02198 11 N-Nitroso-N-methyl-4-aminobutyric Acid (NMBA) 61445-55-4 PA 27 04182 12 N-Nitroso-di-N-butylamine (NDBA) 924-16-3 PA PST 010425 13 N-Nitrosoethylisopropylamine (NEIPA) 16339-04-1 PA 27 02198
- 7. Each reference standards come with a comprehensive Certificate of Analysis detailing the characterization process for the material and ensuring its suitability for both qualitative and quantitative analysis. Pharmaffiliates Analytics and Synthetics Pvt. Ltd. is a research-based organization and for decades we have supported the pharmaceutical community with high-quality reference standards With more than 100,000 reference standards for pharmaceutical quality control, our quality enables your accuracy, helping you to create even better, safer medicines. For prices, discounts and special offers on the above-mentioned products login as registered user at www.pharmaffiliates.com.
- 8. Pharmaffiliates Plot Number 225 ,Industrial Area, Phase II, Panchkula, Haryana- 134109, India +91-172-5066494, +91-172-5066495, +91-90410-78188 https://www.pharmaffiliates.com/ mktg@pharmaffiliates.com Marketing@pharmaffiliates.com
- 9. THANK YOU