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Glenmark Generics receives final ANDA approval for Telmisartan Tablets
Glenmark Generics receives final ANDA approval for Telmisartan Tablets
Mumbai, India, July 8, 2014
Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets. Glenmark will commence distribution of the product immediately.
Telmisartan Tablets are Glenmark’s generic version of Boehringer Ingelheim’s Micardis®. Telmisartan is indicated for the treatment of hypertension.
The approval is for the 20mg, 40mg and 80mg tablets. For the 12 month period ending March 2014, Telmisartan garnered annual sales of USD 250 Million according to IMS Health.
Glenmark receives USFDA approval for telmisartan tablets
Telmisartan, which is the generic version of Boehringer Ingelheim’s Micardis, garnered annual sales of $ 250 million for the 12 month period ending March 2014
Bayer receives Canadian approval for Nexavar to treat differentiated thyroid cancer
SORAFENIB
Bayer receives Canadian approval for Nexavar to treat differentiated thyroid cancer
Health Canada has approved Bayer’s Nexavar (sorafenib tablets) for treatment of patients with locally advanced or metastatic, progressive, differentiated (papillary/follicular/Hurthle cell) thyroid carcinoma, refractory to radioactive iodine.
Nexavar’s approval in Canada is supported by a positive outcome from the Phase III DECISION (‘stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer’) trial.
FOOTBALL BRAZIL 2014
Purdue’s hydrocodone bitartrate tablets granted priority review designation
Hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5); also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine; and may be represented by the following structural formula:
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Hydrocodone Bitartrate
C18H21N03•C4H606•2.5 H20
Molecular weight = 494.5
Purdue’s hydrocodone bitartrate tablets granted priority review designation
Purdue Pharma has been granted priority review designation by the US Food and Drug Administration (FDA) for its hydrocodone bitartrate extended-release tablets for treatment of chronic pain.
The once-daily, single-entity pain medication was formulated to incorporate abuse-deterrent properties designed to make the product more difficult to manipulate for misuse or abuse by various routes of administration.http://www.pharmaceutical-technology.com/news/newspurdues-hydrocodone-bitartrate-tablets-granted-priority-review-designation-4313765?WT.mc_id=DN_News
AstraZeneca’s Forxiga receives positive advice from Scottish Medicines Consortium
DAPAGLIFLOZIN
SYNTHESIS https://newdrugapprovals.org/2013/12/18/dapagliflozin-sees-light/
AstraZeneca announced that the Scottish Medicines Consortium (SMC) has issued positive advice for use of its Forxiga, a selective and reversible inhibitor of sodium-glucose co-transporter-2, as part of a triple therapy regimen for type 2 diabetes.
Is there something like Authorities’ approved production equipment?
Is there something like Authorities’ approved production equipment?
Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. Get the answer here.
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GMP News |
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Is there something like Authorities’ approved production equipment? |
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Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. The question can be answered with a clear ‘No’. There are approvals for pharmaceutical products only, not for production equipment. Authorities or GMP guidelines neither allow equipment, nor do they forbid their usage (with the exception of filters emitting fibers). Here, companies have the freedom of choice but also the responsibility to use the equipment appropriate for their process or product. Standard equipment can be modified to fit best on the own process. GMP guidelines require that the selected equipment is suitable for the application and which can be sufficiently cleaned and maintained. Surfaces that have contact with in-process material or product are supposed to be non-reactive, additive, or absorptive to prevent that the quality decreases beneath the defined requirement. With regard to lubricants and synthetic/sealing materials this is different. The US FDA does not admit any seals, but has a white list of substances in their guidelines text they consider harmless. However, this merely means that these substances are not toxic in small quantities and therefore may be used. It does not imply their suitability for the own process or the proof of compatibility. For instance, EPDM is listed as sealant in 21 CFR 177.2600, but is not resistant in contact with oils or fats and may not be used in these cases. With regard to lubricants there is also a Positive list in the CFR, to which the components of a lubricant must be traceable. Alternatively, lubricants can be listed by the NSF in the so-called White Book. To do this, the NSF offers a registration procedure, which shows the toxicological safety. In addition there are organisations that may be of benefit for the selection of equipment or equipment parts. For example, the EHEDG checks and certifies the cleanability of equipment. The Fraunhofer IPA rates materials with respect to their cleanroom suitability. Here, cleanability, organic resistance, abrasion / particle emission and outgassing are examined. |
GMP Handbooks with all major GMP and GDP Guidelines
GMP Handbooks with all major GMP and GDP Guidelines
Everyone involved in the GMP/GDP environment needs to use the current GMP and GDP Guidelines for reference. The ECA offers a range of booklets with all major Guidelines such as the EU GMP Guide (with all current Annexes), the new EU GDP Guideline, the FDA cGMP Guide and many more. You can order the GMP booklets here.http://www.gmp-compliance.org/eca_handbuecher.html
GMP Publications
….NEW….
….NEW….
ECA Good Practice Guide on Validation
(1st Edition of October 2012)
This document is intended to provide support to both regulators and industry. On one hand, the guide contains the main elements of the new approach (“what to do”). On the other hand, it also serves as a supporting guide for the implementation (“how to do”). The guide contains 163 pages divided in 5 chapters and 4 annexes. The topics covered are among others:•Risk based qualification and validation legacy products
•Statistics
•Case study about process validation in biopharmaceutical manufacturing
•Case study about continuous process verification
•Paperback in the handy format 14,8 x 21 cm
Price*: € 149 Non ECA Members, € 99 ECA Members
Booksellers receive a 15% discount – please ask for a COUPON CODE before ordering!
http://www.gmp-compliance.org/eca_handbuecher.htm
If you want to use the major GMP Guidelines on your smartphone or tablet we recommend to use the free of charge GMP Web App developed by the ECA Academy
http://www.gmp-compliance.org/eca_app.html
The new GMP WebApp from ECA
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ECA is pleased to announce a major development: now you can have all GMP information on your smartphone or Tablet PC (e.g. iPad) – with the new free of charge ECA GMP WebApp.
The unique new WebApp provides a number of GMP features. The App, which works on all smartphones (Apple and Android), is a useful tool for all professionals in the GMP environment. To open it, just go to app.gmp-compliance.org in your browser and the WebApp opens immediately.
To use the App in a convenient way you need to add the ECA icon to the Home screen (see below).
GMP News
From ECA‘s weekly GMP Newsletter you are used to get the latest trends in the GMP environment. Now you can have these news at hand and keep track of all GMP developments any time. You will always find the latest GMP News on your App.
Major GMP Guidelines
The App allows you to access the major GMP Guidelines very easily. Whenever a revised GMP Guide is published the document is available without any update of the App. So you can always check the relevant Guidelines in seconds.
GMP Search
If you are looking for additional GMP information, the „Search“ function is very helpful. Just enter a keyword and select a specific database – or just search in all databases. The GMP Database contains hundreds of GMP articles and more than 1.000 GMP Guidelines. You do not need to search on different websites for the information. The GMP Database provides the links to the most relevant information.
GMP Courses & Conferences
On the ECA website you can scroll a list with all currently offered courses and conferences. The new WebApp does provide that list as well. Simply go on „GMP Courses & Conferences“ to access the complete ECA course and conference programme any time. If you just want to get a list with courses and conferences in a certain area, simply use the „GMP Search“ function decsribed before. And… by the way… if you found the programme you were just looking for… you can even register by using the App.
GMP Guideline Manager
Access to more than 1.200 GMP Guidelines This function is an exclusive service for ECA Members (Company Members will get access for all employees*). After login you will have access to all GMP Guidelines from EU/EMA, FDA, ICH, PIC/S, ICH, APIC, IPEC and WHO. To log in simply use your user name and password from your ECA Membership account. ECA Members have access to two so called Webtrees. One Guideline Tree is structured according to GMP topics. The second Guideline Tree is structured according to authorities. By using the Guideline Trees you can easily access the Guideline of interest.
* Employees of all sites in the country in which the company signed up for the membership.
Solubility Advantage of Amorphous Drugs and Pharmaceutical Cocrystals
Hi everyone, I thought I might begin this week talking about crystallizations. One of the most popular postings I had on my website was one on polymorphs. Although this week’s pick or review is not on polymorphs, it is a burgeoning area of study in the crystallization field. I am talking about the use of co-crystals in active pharmaceutical ingredient crystallizations. This is definitely something I don’t know too much about, but feel that is of great importance. I have done a few crystallizations and wanted to steer clear of amorphous drugs. In fact, a few of the projects that I have worked on, the product was not crystalline. One of them had to spray-dried as a mesylate salt. Adding another compound into the mix didn’t seem like a solution at the time, but who am I to know ? Would you have considered it ?
So I was intrigued when I came across…
View original post 829 more words
The ‘yin and yang’ of malaria parasite development
Scientists searching for new drug and vaccine targets to stop transmission of one of the world’s deadliest diseases believe they are closer than ever to disrupting the life-cycle of this highly efficient parasite.
Dr Rita Tewari in the School of Life Sciences at The University of Nottingham has completed what she describes as a ‘Herculean study’ into the roles played by the 30 protein phosphatases and 72 kinases – enzymes that act as the ‘yin and yang’ switches for proteins – as the malaria parasite develops in the body and then in the mosquito gut.
Research is published today, Wednesday July 9 2014, in the academic journal Cell Host and Microbe, describes the work that has just been completed into the role of protein phosphatases.
Dr Tewari said: “This latest study identifies how protein phosphatases regulate parasite development and differentiation. Our research provides a systematic functional analysis for all…
View original post 917 more words
Scientists discover that pluripotency factor NANOG is also active in adult organisms
A cross section of a mouse esophagus. The dark brown staining shows epithelial cells containing NANOG protein. Credit: CNIO
Scientists from the Spanish National Cancer Research Centre (CNIO) have discovered that NANOG, an essential gene for embryonic stem cells, also regulates cell division in stratified epithelia—those that form part of the epidermis of the skin or cover the oesophagus or the vagina—in adult organisms. According to the conclusions of the study, published in the journal Nature Communications, this factor could also play a role in the formation of tumours derived from stratified epithelia of the oesophagus and skin.
The pluripotency factor NANOG is active during just two days previous to the implantation of the embryo in the uterus (from day 5 to day 7 post-fertilization). At this critical period of development, NANOG contributes to giving embryonic stem cells the extraordinary capacity to make up all of the tissues that…
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Is This The Newest Trend For Controlling Polymorphism ?: A New Strategy of Transforming Pharmaceutical Crystal Forms (OLD)
This was a post from my old website PHARMNBIOFUEL.COM that was posted on 2011-02-19. I am currently working on getting some new information on the website, but during this time, I have a few posts from the old website that are quite interesting. I have a few things on the go, plus RBC Bluesfest is happening.
Hi Everyone. Hope everyone’s research is going well. Sometimes, you are perusing the journals and you come across the occasional paper that you know everyone should know about. Perhaps it is the latest, greatest technique, synthesis, isolation etc. and people should be made aware of it or it may fade into that big pile of papers on your desk or you don’t find out about it until the most inappropriate time. Today, this paper is to all the process chemists in the pharmaceutical industry that have ever worked on polymorphs. That is, probably…
View original post 716 more words
DR ANTHONY MELVIN CRASTO
ORGANIC SPECTROSCOPY
New Drug Approvals 