May 7, 2013
By: DPLA Research Team
Beginning July 2nd of this year, under the requirements of the Falsified Medication Directive (FMD), there will be only three ways an API can be approved for entry into the EU. The new restrictions on APIs are designed to keep counterfeit or substandard APIs from being used in drugs dispensed in the EU. The three ways an API may enter the EU are:
It’s a question that many pharmaceutical companies face every day: do we purchase products from the manufacturer, or do we buy through a trader?
According to Gideon Schurder, commercial director at Yes Pharma, it depends. Specifically, he says, it depends on what you’re trying to achieve, the number of manufacturers available for the product, and the relationships you and your trader have.
“Generally speaking, if there are only a small handful of manufacturers in one country for a certain product,” he says, “then my personal preference would be to try first to work directly with the manufacturers.”
In hopes of cutting costs, many pharmaceutical companies opt to buy APIs and ingredients from producers in China. But are they really saving money by doing this? Are there downsides to working with a Chinese producer that make it just not worth it?
DPLA is heading to Madrid, Spain, this fall for the CPhI Worldwide conference Oct. 9-11. In preparation for our upcoming getaway, we’ve put together a handy dandy list of all Madrid has to offer. Make no mistake, though, this is no average travel guide. We’ve included only off-the-beaten-path hidden gems you won’t see on any old tourist map. From unique art galleries and historic restaurants to local entertainment spots and beautiful parks, there’s something for everyone in our guide!
Planning future generic drug releases in Europe just got easier thanks to the latest innovation from Drug Process Licensing Associates (DPLA).
PHILL Patent Explorer, a unique new tool from DPLA, helps pharmaceutical companies decipher the patent landscape in order to pick and plan upcoming generic drug launches. With information on patent expiration dates, SPC expiries and pediatric extension expiries, as well as First Marketing Authorizations, companies can get the full and complete outlook of when drugs will be available for generic release and when formulations can be sold.
The pharmaceutical industry is a worldwide, far-reaching entity. Drug producers and manufacturers are located everywhere – the United States, China, the United Kingdom, and more – and with each country comes its own unique industry needs, regulations and legislation.
To keep the pharmaceutical industry thriving, many countries have associations to which industry businesses and leaders can belong. These associations allow for networking, continued education, and increased knowledge and awareness of pharmaceutical issues. They also often help to influence national legislation for pharmaceutical-related issues.
Popular associations include the British Generic Manufacturers Association, European Generic Medicines Association, the Generic Pharmaceutical Association, the Pharmaceutical Research and Manufacturers of America, and many more. Each association varies slightly, but all aim to bring together leaders within the pharmaceutical industry to improve quality and performance all over the world.
DPLA (Drug Process Licensing Associates, LLC) is off and running again with the launch of their newest database product called PHILL. PHILL, which stands for PHarmaceutical InteLLigence, is a database of bulk drug and intermediates producer information pertinent to members of the chemical and pharmaceutical industry. It also includes regulatory information such as Drug Master Files, Veterinary Master Files, Certificates of Suitability and Drug Approvals.
Drug Process Licensing Associates (DPLA) has announced the filing of their third process patent. This most recent patent has been filed for Sitagliptin, the active ingredient in Januvia (Merck), used to lower blood sugar levels in patients with type 2 diabetes. The patent will protect the manufacturing process for a period of 20 years.
Former President and Founder of Chemical Information Services, Ron Schwarz, has returned to the chemical and pharmaceutical industry with the launch of his new entity, Drug Process Licensing Associates.
Founded in 2010 along with chemist Dr. Milan Soukup from Hoffman La-Roche, Drug Process Licensing Associates evaluates existing manufacturing processes for active pharmaceutical ingredients and then creates new, novel and more cost effective alternative routes which are patented and then licensed to their clients. “This is an idea that I’ve had for a very long time,” Schwarz said. “The pharmaceutical industry is one that I know very well and I am certain that we can create positive results for our clients.”
