Sun Pharma Metformin

Who Manufactures Your Metformin - Does It Make A Difference ?

Hello all, it's been awhile since I've actually posted, have been checking in & reading the posts. Well...I've got a dilemma here and thought who better to ask than the folks on this board, right? I take Metformin HCL ER once daily. When I had my prescription filled this time I noticed the manufacturer had changed. I remember seeing a thread on this board quite some time ago referring to manufacturers/medications but can't seem to locate it. - Does this medication perform differently depending upon who manufactured it? - Who is the manufacturer of your Metformin? - Is one 'brand' better than the other of Metformin? Previously mine had always been filled using 'Teva USA' as the manufacturer; that has now switched to SUN PHARMACEUTICALS. Kroger Pharmacy's explanation for the switch is 'Teva's prices must have risen, and in order to keep this medication on the $4 list, we will now be carrying the other brand. You guys are awesome, so knowledgeable; I've learned so much on this board...so....thoughts? I am always leery about generic meds being as effective as the name brand meds. I started doubting the generics years ago when I was on Fen-Phen, the diet drugs. The one Phen....is phentermine. The name brand is Fastin. Back when I was taking it, it was so popular that pharmacies had a hard time keeping it in stock, so I could never get a full prescription, I could only get a partial prescription....if they had it at all. I got tired of this, so I asked for the name brand....Fastin, which they always had since most insurance companies wouldn't pay for the name brand. The first time I took the Fastin.....man, what a difference! With this type of drug, you can feel it working on you. You can feel the energy surges, and what I call the "heightened alertness". With the generic br Continue reading >>

Riomet Recall: Sun Pharma Warns Against Diabetes Drug Contamination

Riomet recall: Sun Pharma warns against diabetes drug contamination Sun Pharma has recalled two lots of its type 2 diabetes treatment Riomet, citing microbial contamination. Sun Pharmaceutical Industries US-based subsidiary issued the voluntary nationwide recall on Friday November 24, stating the metformin hydrochloride oral solution 500mg/5mL was made by a contract manufacturer. According to the Indian-headquartered firm, two lots of the drug were found to be contaminated with the fungus Scopulariopsis brevicaulis during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET). Use of Riomet potentially could result in a risk of infection, especially in the immunocompromised patient, said the firm in a statement . The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis and disseminated infections. On Friday, the firm had not received any reports of adverse events related to the recall. Sun Pharma did not disclose the name of its manufacturing partner in the statement. According to the US Food and Drug Administration, in 2010 Ranbaxy Laboratories marketed Riomet and outsourced manufacturing to its subsidiary, Ohm Laboratories. Sun Pharma acquired Ranbaxy in 2015, along with Ohm Laboratories. Sun Pharma did not respond to a request for comment before the time of publishing. Copyright - Unless otherwise stated all contents of this web site are 2018 - William Reed Business Media Ltd - All Rights Reserved - Full details for the use of materials on this site can be found in the Terms & Conditions Continue reading >>

Metformin By Sun Pharma

Lactic acidosis caused by metformin is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33, patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the people who develop it. It is also important for your liver to be working normally when you take metformin. Your liver helps remove lactic acid from your blood. Make sure you tell your doctor before you use metformin if you have kidney or liver problems. You should also stop using metformin and call your doctor right away if you have signs of lactic acidosis. Lactic acidosis is a medical emergency that must be treated in a hospital. Signs of lactic acidosis are: This may be a sign of lactic acidosis or another serious side effect. Common side effects of metformin include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Renal clearance is approximately 3. In blood, the elimination half-life is approximately Specific Populations Patients with Type 2 Diabetes In the presence of normal renal function, there are no differences between single- or multiple-dose pharmacokinetics of metformin between patients with type 2 diabetes and normal subjects nor is there any accumulation of metformin in either group at usual clinical doses. The pharmacokinetics of metformin HCl extended-release tablets in patients with type 2 diabetes are comparable to those in healthy normal adults. Race No studies of metformin pharmacokinetic parameters according to race have been performed. After 12 weeks treatment, mean HbA1c had increased from baseline by 0. At the fi Continue reading >>

Sun Pharma Recalls Two Batches Of Diabetic Drug From Us Market - Business Line

Sun Pharma recalls two batches of diabetic drug from US market Sun Pharmaceutical Industries has started recalling two batches of Riomet (metformin hydrochloride) Oral Solution voluntarily from the US market due to microbial contamination. Riomet (metformin oral solution) is an oral diabetes medicine that helps control blood sugar level. According to a notification put up by the US Food and Drug Administration in its website, the recall was initiated by the firm under Class-II classification. The notification did not mention the quantity that is being recalled. The Riomet (Metformin Hydrochloride Oral Solution) has been found to be contaminated (with Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval, Sun Pharma informed the FDA in a letter. According to the USA health regulator, Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The drug was manufactured for Ranbaxy Laboratories Inc Jacksonville in USA by a contract manufacturer and distributed by Sun Pharmaceutical Industries subsidiary in Cranbury, New Jersey. The Sun Pharma stock closed at Rs 528.60 apiece on BSE, up 0.28 per cent over previous close. Continue reading >>

Sun Pharma Gets Us Regulator's Nod For Generic Diabetes Treatment Drug

Sun Pharma Gets US Regulator's Nod For Generic Diabetes Treatment Drug New Delhi: Sun Pharmaceutical Industries has received a final nod from the US health regulator for its generic Metformin Hydrochloride extended release tablets used for treatment of diabetes, and plans to launch them in next few weeks in the American market. One of the subsidiaries of the company "has received final approval from United States Food and Drug Administration for its abbreviated new drug application (ANDA) for generic version of Glumetza Metformin Hydrochloride extended release tablets," Sun Pharma said in a filing to the BSE. The approval is for the tablets in the strengths of 500 mg and 1000 mg, it added. The tablets are generic versions of Santarus Inc's Glumetza tablets, Sun Pharma said. "As per IMS MAT June 2016, these tablets have annual sales of approximately $1.2 billion in the US," it added. The commercial launch of these tablets in the US is expected over the next few weeks, it said. Glumetza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. At 3:00 p.m., shares in Sun Pharma were trading 0.65 per cent lower at Rs 829.65 apiece on the BSE, whose benchmark Sensex index was down 0.14 per cent. Continue reading >>

Sun Pharma Plant Joins The Fda List Of Banned Indian Facilities

Sun Pharma plant joins the FDA list of banned Indian facilities Two years ago the FDA turned to Sun Pharma to help it overcome a cancer drug shortage after a Ben Venue plant closed for manufacturing problems. Now it is Sun whose manufacturing has been called into question. The FDA has issued a ban against one of its plants in India continuing a crackdown there that has also blocked facilities by Ranbaxy Laboratories and Workhardt from the U.S. market. The exact reasons for the import alert have not yet been disclosed, but a Sun Pharma plant in Karkhadi in Gujarat, India, was included on the FDA's import alert list Tuesday. A spokeswoman told Reuters that the plant accounts for less than 1% of the company's sales, so the ban would have little effect on its revenues. It is one of 25 Sun manufacturing facilities around the world, of which 11 are in India and three are in Gujarat. She said the company was working on the issues raised by FDA inspectors. The plant manufacturersantibiotic cephalosporin. The ban comes only weeks after FDA Commissioner Margaret Hamburg returned from a trip to India where she discussed quality issues with government and industry officials. The country provides about 40% of the generic and over-the-counter drugs U.S. consumers take, and so the FDA has been placing more personnel and more emphasis on Indian drug plants. She noted during her trip that many of India's drugmakers have modern facilities with top-notch operations. Still, the failures have been significant. Ranbaxy Laboratories, India's biggest generic drugmaker and one that has been first to market with many generic drugs, has been under tight FDA oversight for years for faking drug data at some plants. The agency has banned all four of its FDA-approved plants in India, including two i Continue reading >>

Fda Warns Sun Pharmaceutical Of Quality Problems

FDA Warns Sun Pharmaceutical of Quality Problems The US FDA has sent Indian drug maker Sun Pharmaceutical Industries a letter warning that its quality control problems persist. Sun Pharmaceutical Industries is Indias largest drug manufacturer. It supplies many generic medications to the U.S. market. But the giant is once again in trouble with US regulators. The Food and Drug Administration has issued another warning letter to the company because one of its major manufacturing plants has fallen short on quality control. The problems the FDA noted in its most recent communication are very similar to those named in a letter sent earlier this year. Sun Pharmaceutical purchased another large Indian generic drug maker, Ranbaxy, which also ran afoul of FDA on quality control problems. Ranbaxy agreed to pay $500 million in fines in May 2013 after pleading guilty to making false statements and violating drug safety laws. Another Indian generic drug manufacturer, Dr. Reddys Laboratories, has also been the target of FDA scrutiny. The company received a warning letter last month because of quality control problems, especially data integrity. Indian drug makers provide at least 40 percent of the generic drugs Americans take each year. This is not the first time we have written about trouble with poor quality control in certain Indian manufacturing plants. You can read more here and here . The message we hear repeatedly from the FDA about generic drugs is thatthe agency has everythingunder control and there is nothing to worry about. Nevertheless, we keep reading about violations in India and other countries. Unfortunately, the FDA rarely reveals which medications have been affected. There is no country of origin label on your prescription bottle so you have no way of knowing whethe Continue reading >>

Sun Pharma: Sun Pharma Recalls Two Batches Of Diabetic Drug From Us Market - The Economic Times

Sun Pharma recalls two batches of diabetic drug from US market ETPrime Amazons fintech flywheel widens its orbit HYDERABAD: Sun Pharmaceutical Industries has started recalling two batches of Riomet (metformin hydrochloride) Oral Solution voluntarily from the US market due to microbial contamination.According to a notification put up by the US Food and Drug Administration in its website, the recall was initiated by the firm under 'Class-II' classification. The notification did not mention the quantity that is being recalled. "The Riomet (Metformin Hydrochloride Oral Solution) has been found to be contaminated (with Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval," Sun Pharma informed the FDA in a letter. Riomet (metformin oral solution) is an oral diabetes medicine that helps control blood sugar level.According to the USA health regulator, Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The drug was manufactured for Ranbaxy Laboratories Inc Jacksonville in USA by a contract manufacturer and distributed by Sun Pharmaceutical Industries' subsidiary in Cranbury, New Jersey.The Sun Pharma stock closed at Rs 528.60 apiece on BSE, up 0.28 per cent over previous close. Continue reading >>

Sun Pharma Recalls Some Generic Drug Batches In Us

AgriApp: An app for farmers to help them improve crop output Mumbai: Indian generic-drug maker Sun Pharmaceutical Industries Ltd. has recalled some batches of drugs in the US after complaints of bottling mix-ups. Sun Pharma is recalling a batch of generic diabetes tablets after a customer complained of finding pills of an epilepsy medication mixed in. Separately, rival Ranbaxy Laboratories Ltd. pulled two batches of its version of Pfizer Inc.s Lipitor cholesterol- lowering drug from the US market. Both recalls were listed in the Food and Drug Administrations enforcement report for the week of 5 March. FDA officials have said they plan to tighten rules on how they regulate the generic-drug industry as a way to convince American consumers that safeguards are in place. Generic drugs, which make up almost 80% of the medicine used in the US, helped Americans save $193 billion in 2011 as health-care costs rise and insurers force more consumers to use them. Sun initiated a voluntary recall of 2,528 bottles of metformin hydrochloride extended release tablets after a customer complained of the presence of some gabapentin tablets, a drug used to treat seizures, in a bottle, according to a posting on the FDA website. The batch was manufactured in April 2013 and was set to expire in March 2016. Sun Pharma is examining the issue, and would not have anything specific to share beyond the announcement that the US FDA has made, the company said in a statement. Suns recall of the batch of metformin hydrochloride was initiated on Jan. 28, according to the FDA posting. Ranbaxy recalled 64,626 bottles of its copies of Lipitor after a pharmacist complained of a 20-milligram pill in a sealed 10-milligram bottle, according to an FDA website posting. The recall, its second of atorvastatin in t Continue reading >>

Differing Brands Of Generic Metformin Behave Differently

Dr. Bernstein has been preaching about this on his web telecasts for years, but it bears repeating: If you are having problems with generic metformin or not seeing it make much impact on your blood sugar, change brands before you assume it isn't working or that you can't tolerate it. I just had this message brought home to me when my pharmacy (Walgreens) filled my prescription for metformin ER with tablets from SunPharma instead of the ones from Teva they'd given me for years. The pills were about half the size of the ones I'd been getting, which suggested they contained less of a matrix substance to slow the release of the metformin. And sure enough, when I took the same dose I had been taking with no problems with the Teva brand metformin, I felt exhausted and semi-poisoned. It felt just like when I had taken an overdose of metformin some years ago, when my family doctor prescribed an overdose after confusing the dosage instructions for regular metformin--which can be taken in larger doses--with those of metformin ER. Not only that, but my fasting blood sugars went up. Clearly the SunPharma metformin ER was not behaving like a true extended release should and releasing slowly through a 24 hour period but was hitting my blood stream all at once and then was done. A quick visit to Google revealed that Sun Pharmaceuticals is an Indian company and that in the past the FDA has forced them to recall batches for quality issues. When it was time to refill my prescription, I called my pharmacy and spoke with the pharmacist who shrugged off my concerns and told me I'd have to speak to the pharmacy manager (not available that day.) So I got on the phone and called other local pharmacies and asked them what brand they were dispensing. Two of them still carry the Teva brand, so I Continue reading >>

Sun Pharma Gets Usfda Nod For Generic Diabetes Treatment Drug - Business Line

Sun Pharma gets USFDA nod for generic diabetes treatment drug Sun Pharmaceutical Industries has received final nod from the US health regulator for its generic Metformin Hydrochloride extended release tablets used for the treatment of diabetes. The company plans to launch them in the next few weeks in the American market. One of the subsidiaries of the company has received final approval from United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for generic version of Glumetza Metformin Hydrochloride extended release tablets, Sun Pharma said in a BSE filing. The approval is for the tablets in the strengths of 500 mg and 1,000 mg, it added. The companys tablets are generic versions of Santarus Incs Glumetza tablets, Sun Pharma said. As per IMS MAT June 2016, these tablets have annual sales of approximately $1.2 billion in the US, it added. Commercial launch of these tablets in the US is expected over the next few weeks, it said. Glumetza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Shares of Sun Pharmaceutical Industries were today trading down by 0.53 per cent at Rs 830.65 on the BSE. Continue reading >>

Sun Pharma Recalls 2 Lots Of Diabetes Drug Riomet In Us

Nov 24, 2017 08:39 PM IST | Source: PTI Sun Pharma recalls 2 lots of diabetes drug Riomet in US Use of contaminated Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. Sun Pharma on Fridaysaid its US- based subsidiary is recalling two lots of diabetes drug Riomet due to microbial contamination. Sun Pharmaceutical Industries Inc (SPII), a wholly owned subsidiary of the company, is voluntarily recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), to the retail level, the Mumbai-based drug major said in a statement. The product is manufactured for SPII by a contract manufacturer, it said adding that the recall is being conducted with knowledge of the US FDA. The Riomet has been found to be contaminated with microbe, Scopulariopsis brevicaulis. The contamination was discovered during sample preparation for the antimicrobial preservative effectiveness testing (AMPET) being performed as part of the 12-month stability study interval, Sun Pharma said. Use of contaminated Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. "To date, SPII has not received any reports of adverse events related to this recall," the company said. Riomet is indicated to treat type 2 diabetes mellitus in adult and children age 10 and above. Continue reading >>

Metformin Sun Pharma

Oblong white tablet marked only 142 Is it metformin? ## yes it is a slow release metformin ## There is a tablet manufactured by Sun Pharmaceuticals with this marking that they list as containing 500mgs of Metformin, which is most commonly used to help lower and control blood sugar levels. The FDA lists its typical side effects as possibly including nausea, dizziness, headache, flatulence, and hypoglycemia. You can click this NDC code to view more details: 62756-0142 And yes, it is a time released formulation. Is there anything else I can help with? ... Just got my Metformin ER 750 refilled. The pills look different... could be different manufacturer? One has 93 on one side and 7212 on the other. The other has 143 stamped on one side and nothing I can see on the other side. Help? ## Yes, they are both the same medication, a controlled release formulation of Metformin in a 750mg dosage. The one with the 93 is manufactured by Teva Pharmaceuticals and the 143 is manufactured by Sun Pharmaceuticals. It is common for the pharmacy to switch which generic they supply, depending on which company was offering the cheapest price, when they needed to restock their supply. It's how they keep their prices as low as possible for customers without insurance. Is there anything else I can help with? ## I was prescribed with CLOPIDOGREL -PLAGERINE 7... ... pink tablet with the numbers 143 on it ## Is it an oblong tablet? If so, Sun Pharmaceuticals lists it as containing 750mgs of Metformin, which is most commonly used to treat high blood sugar, and other conditions as deemed appropriate by your doctor. The FDA lists its typical side effects as possibly including nausea, dizziness, headache, stomach pain, and flatulence. The inactive ingredients may include: xanthan gum hypromellose sodiu Continue reading >>

Sun Pharma Receives Tentative Approval For Metformin Hcl, Sitagliptin Phosphate

Sun Pharma receives tentative approval for Metformin HCL, Sitagliptin Phosphate Sun Pharma receives tentative approval for Metformin HCL, Sitagliptin Phosphate India Infoline News Service | Mumbai | April 13, 2018 09:23 IST The drug is sold under the brand Janumet, which clocked sales of $2.3bn in 2017. Janumet with Januvia together clocked global sales of $6.1bn in 2017. Article saved successfully to my page. You must be Logged in to save article. A+ a- 0 Open FREE Demat Account and get access to indepth research on 500 stocks By clicking on submit button, you authorize IIFL & its representatives & agents to provide information about various products, offers and services provided by IIFL through any mode including telephone calls, SMS, letters etc. . you confirm that laws in relation to unsolicited communication referred in National Do Not Call Registry as laid down by Telecom Regulatory Authority of India will not be applicable for such information/ communication. Sun Pharma has received tentative approval for Metformin HCL and Sitagliptin Phosphate, as per the USFDA website. Combination of Metformin HCL and Sitagliptin Phosphate are sold under the brand Janumet by Merck Sharp and Dohme Corp. Sun Pharma already has tentative approval for Sitagliptin Phosphate, which is sold under Januvia. Janumet with Januvia clocked global sales of $6.1bn in 2017. Metformin HCL and Sitagliptin Phosphate medicines help lower blood sugar in adults with type 2 diabetes. They have been under pricing pressure, but have been showing strong volume growth globally, as per Mercks Q4 results . The first patent on this drug is expected to expire in 2019, while several other patents will expire between 2022-2028. Janumet, as per Bloomberg data, clocked $2.3bn sales in 2017. This is expected to Continue reading >>

Full List Of Metformin Recalls, Fda 2012-2017

Metformin is a popular generic, widely used and generally well tolerated for the treatment of type 2 diabetes. If you use sharps check out this helpful article on Sharps Container Disposal. Despite being made by dozens of manufacturers around the world, to date there have been only 15 recalls of the popular drug, with most being minor. The exceptions are a 27,000 kilo recall from Smruthi Organics in early 2014, and a recall of 117,049 sample cartons from Bristol-Myers Squibb in 2012. The next biggest Metformin recall after that came from Actavis Laboratories and affected 13,284 bottles in 2015. Metformin Recalls There have been 15 total recalls of Metformin from 2012 through 2017. The Metformin recalls involved a grand total of over 150,000 bottles of the popular diabetes medication. The most recent was a Class II event in late 2016 from Ascend Laboratories. Several other companies have been the focus of Metformin recalls. Most of the incidents were relatively small, in the sub-7,000 bottles range. The biggest by pill count was a 2012 recall from Bristol-Myers Squibb that affected over 117,000 sample packs. Metformin Facts Metformin is a diabetes medication in oral form that helps manage blood sugar levels. It’s used in cases of type 2 diabetes. It’s sometimes given along with insulin and other medications. It’s not meant for type 1 diabetes. Serious side effects can include allergic reaction with difficulty breathing or facial swelling, and dangerous or even fatal lactic acidosis marked by numbness, fatigue, slow heart rate, and vomiting. More common side effects are nausea, upset stomach, vomiting, and diarrhea. Major Metformin Recalls There have been three major Metformin recalls and several minor ones. The biggest in terms of bottles/cartons was a 2012 recall Continue reading >>