Sun Pharmaceutical Drug Plant Under Import Ban From FDA
Sun Pharmaceutical Drug Plant Under Import Ban From FDA
Original post by: Guardianlv.com – Added by Ashley Campbell on March 13, 2014.
Sun Pharmaceutical is the latest pharmaceutical company in India to be added to the U.S. Food and Drug Administration (FDA) import alert list. This affects the Sun Pharmaceutical plant in Karkhadi, Gujarat. This ban comes after an inspection by the FDA. Sun Pharmaceutical does have facilities in other locations that have passed inspection.
India plays
a key role in supplying America with generic drugs. They are the second largest supplier of generic medications to America, coming in behind Canada. There have been 20 pharmaceutical facilities added to the import alert list by the FDA since January 2013, most notably are the two Wockhardt Ltd. facilities and the two facilities from Ranbaxy.
The U.S. FDA cites the reason for the ban as non-compliance of current Good Manufacturing Practice regulations. Further details regarding what was in non-compliance have not yet been released. Sun Pharmaceutical has stated that it is already taking steps to initiate corrections. They released a statement saying that they are “fully committed to compliance.”
In late January, Sun Pharmaceutical initiated a voluntary recall of a little over 2,500 bottles of diabetic medication, after a bottling mistake. The bottles, which should have contained the diabetic medication metformin hydrochloride, instead contained something different. The contents of the bottles were actually gabapentin tablets; gabapentin is used in treating seizures.
Regarding the Sun Pharmaceutical plant and the other facilities currently under a ban on drug import, Margaret Hamburg, U.S. FDA chief, mentioned that India is not being targeted, they are going through the regular inspections which are required for safety. FDA officials have also commented that plans are being made to tighten rules regarding the regulation of the generic drug industry. The generic drug industry played a role in saving Americans $193 billion in 2011. Analysts have suggested that as operations in India grow, these facilities will need to invest more in quality control.
The ban on Sun Pharmaceuticals is only on one plant, which should keep financial casualties at a minimum. The company has other facilities, which have passed U.S. FDA inspections. In March 2013, Vice-President of Research at Angel Broking, Sarabjit Kour Nangra, stated that in March 2013 Sun Pharmaceutical had 12 U.S. FDA facilities, which are located in different regions. Six of these facilities are located in the United States, three are in India, and one each are located in Canada, Hungary, and Israel.
Sun Pharmaceutical has said that the drug import ban from the U.S. FDA will only have a negligible affect on their financial standing. This is because the sales from the one facility that is under the ban are not significant enough to make a large impact. They have not revised their earlier report that estimated the company would experience a 29 percent growth rate this year, which ends March 2014. However, the shares for Sun Pharmaceutical dropped 5.03 percent; at the close of the Bombay Stock Exchange on Thursday the shares were at RSs. 573.60. This is the biggest decline for the company since March 2012. This comes after the 2.5 percent drop on Monday which occurred after the FDA posted notice of the voluntary diabetic drug recall from Sun Pharmaceutical.
Full Article: http://guardianlv.com/2014/03/sun-pharmaceutical-drug-plant-under-import-ban-from-fda/
Urgent – Upcoming decisions regarding the Affordable Care Act
As advocates for the Independent Pharmacy, we at TRxADE want to make sure that your voice is heard on the upcoming decisions regarding the Affordable Care Act; which greatly impact the future of your pharmacy.
We urge you to take action NOW.
- Go to: www.TRxADE.com and download petition from the link located at the top of the site.
- Send fax using your company fax cover letterhead.
- Fax one signed copy for submission to the CMS – Fax#: 202-683-7011
- Fax this same document again to your state Senator. Include Senator’s Name to top of the petition (a list of state Senator Fax numbers can be found with this packet for your convenience).
- Be sure to add your comments of your personal experiences at the bottom of petition.
- FORWARD to as many of your pharmacy colleagues as possible. This is IMPORTANT!
BE SURE INCLUDE ONLY YOUR COVER AND THE PETITION IN THE FAX. DO NOT INCLUDE THIS COVER PAGE OR SENATOR LIST.
This petition addresses:
- The elimination of Preferred Networks
- The need for a level playing field on reimbursements – Equal Pay for Equal Work
- More control over the initiation and adequate reimbursement of MTM Services
- The ability to refute reimbursements set by future CMS benchmarks
OUR DEADLINE IS 3:00 PM EST MARCH 7th !!!! YOU MUST SIGN AND FAX NOW!!
FDA and hospitals are scrambling as the shortage of hydration products deepens
FDA and hospitals are scrambling as the shortage of hydration products deepens
The FDA has worked to face down shortages of important, sometimes life-saving, drugs that have sprung up in recent years. But occasionally something as mundane as saline solution can set off a scramble, particularly when the flu season puts added pressure on supplies, leaving hospitals to look for ways to preserve scarce products.
“We have not heard of anyone running out of the IV solutions at this point, but we know the hospitals are not comfortable with the low supplies,” Valerie Jensen, FDA’s associate director for drug shortages told Reuters. Escalating hospital admissions for flu is adding pressure, she said. “The increase in demand pushed this into a shortage.”
Hospitals in the U.S. go through millions of bags of such products in a week, the FDA said. Bona Benjamin with the American Society of Health System Pharmacists, told the news service that the shortage is serious and hospitals are using oral rehydration fluids or smaller IV saline bags with slower drip rates when appropriate to cope.
Read more: FDA and hospitals are scrambling as the shortage of hydration products deepens – FiercePharma http://www.fiercepharma.com/story/fda-and-hospitals-are-scrambling-shortage-hydration-products-deepens/2014-01-30#ixzz2uuRjX5mB
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Roche’s Genentech tells the FDA to expect a brief Tamiflu shortage
Roche’s Genentech tells the FDA to expect a brief Tamiflu shortage
A short production interruption at a drug manufacturing plant is generally not something that will elicit a lot of publicity, but it is different when it involves a drug treatment for children during the flu season. And so the FDA let it be known Wednesday that there may be spot shortages of Tamiflu liquid because of manufacturing issues at a Genentech plant.
The FDA posted on its shortages website Monday that Genentech is experiencing temporary delays in manufacturing the oral suspension of Tamiflu and that a brief shortage is expected in early to mid-January. It said that capsule forms of the product remain available. The FDA said Genentech cited an increase in demand; however, healthcare professionals told the Philadelphia Inquirer that this has been a typical flu season. The Centers for Disease Control and Prevention (CDC) reports that case numbers remain below epidemic levels.
Tara Iannuccillo, a spokeswoman for Genentech, said in an email that “There has been strong and early demand for Tamiflu Oral Suspension (OS) and we are experiencing a temporary delay in the packaging of Tamiflu OS. A brief shortage of Tamiflu OS is expected through mid-January and as such, we may be unable to fill complete orders from distributors for a limited time. We expect to have additional supply of Tamiflu Oral Suspension in mid-January 2014.”
Genentech, a division of Switzerland-based Roche ($RHHBY), warned the FDA a couple of days ago that it was having problems keeping up with demand for the liquid form of the product, Dr. Michael Jhung, a medical officer with the CDC’s influenza division, told the Philadelphia Inquirer. He said the shortages will only be seen in some parts of the country and should only last about a week. He said the result may be that some children will be sicker longer. Jhung also said that a pharmacy can break open capsules and mix them into a liquid if it is needed. The FDA website has a link to instructions for healthcare providers on how to do that.
Roche has had to deal with shortages before, even suggesting there might be supply problems for its highly anticipated cancer drug Perjeta in 2012 just after it was approved by the FDA. It got that issue resolved quickly. At about the same time, the drugmaker ran into shortages of its osteoporosis drug Boniva because it had cut production in the expectation that sales of generic versions would reduce demand.
Actavis acquires Forest for $25bn
Actavis acquires Forest for $25bn
Ramps up its shift into specialty pharmaceuticals
Actavis has announced its largest acquisition to date, confirming a $25bn takeover of Forest Laboratories.
Once finalized the generic drug company will gain blockbuster franchises in CNS, gastroenterology, women’s health, urology and cardiovascular, and combined annual revenues expected to top $15bn next year.
Paul Bisaro, chairman and CEO of Actavis, said: “With this strategic combination, we create an innovative new model in specialist pharmaceuticals leadership, with size and scale, a balanced offering of strong brands and generics, a focus on strategic, lower-risk drug development, and – most important – the ability to drive sustainable organic growth.
“Bolstered by one of the deepest and most diversified product portfolios in the industry with an exceptionally strong pipeline, this transaction creates a powerful engine for generating long-term, double-digit revenue and earnings growth.”
Bisaro will lead the combined company, while Forest CEO and president Brent Saunders, along with two other members of the Forest board, will join Actavis’ board of directors.
The deal continues Actavis’ shift into specialty medicines, an area that will now be responsible for around 50 per cent of its revenues, complementing its generic drug operations, where it is ranked fourth in the market behind Teva, Sandoz and Mylan.
The combined company will have an annual R&D budget of more than $1bn and Actavis gains a number of new product candidates, with those nearing regulatory submission including treatments for Alzheimer’s disease, cardiovascular disease and COPD.
The deal would also provide economies of scale in the region of $1bn and give Actavis the size needed to negotiate competitive positions for its medicines among US hospitals, insurers and doctors.
Expected to be completed midway through this year the Forest deal will be the Actavis’ biggest-ever purchase, eclipsing last year’s $8.5bn acquisition of Ireland’s Warner-Chilcott as well as the $5.6bn reverse takeover by Watson in 2012.
Read Full Article Here: http://www.pmlive.com/pharma_news/actavis_acquires_forest_for_$25bn_544832
US to expedite imports for some drugmakers under new supply chain plan
US to expedite imports for some drugmakers under new supply chain plan
By Zachary Brennan, 19-Feb-2014
The US FDA announced on Monday that it would initiate a Secure Supply Chain Pilot Program to enhance the security of imported drugs.
Full Article: http://www.in-pharmatechnologist.com/Regulatory-Safety/US-to-expedite-imports-for-some-drugmakers-under-new-supply-chain-plan
