How to Improve Your Generic Drugs (in Particular Carbapenem Products)?

Jakarta, 2 April 2013

Generic drugs are defined as a drug that must contain the same active ingredients as the original formulation. The USFDA defines them as drug that are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the USFDA) identical in dose, strength, route of administration, safety, efficacy, and intended use[1] If you are a generic drugs manufacturer, how could you improve your products then? For sure a generic cannot improve its efficacy beyond the original (or innovator). Therefore, safety is a major aspect to improve your products. By safety, it means we could select the API (Active Pharmaceutical Ingredients) which could offer a better impurities and particulates.

There are 4 (four) quality differentiation factors that you could consider when you assess the API.[2]

  • SOLUBILITY: Better solubility means it contains a finer APIs and provides the convenience of use in hospitals.

  • COLOR after DISSOLUTION: No color change in a longer time is regarded as a finer quality.

  • RELATED SUBSTANCE: A lower level of related substance is regarded a better quality.

  • FOREIGN PARTICLES: A lower level of foreign particles is regarded a better quality. The pathological significance of particles impurities in the branded and generic antibiotic thimble in the seriously patients treatment. An experimental study shows that particle impurities in the vein injecta (in generic drugs) can cause microcirculation obstacles. Especially when the microcirculation has been damaged.

JW Pharmaceutical Co., Ltd. is one of the leading (top ten) pharmaceutical companies in Korea. The company was established back in 1945 as one of the pioneer in injectable drugs (including IV products). As for Carbapenem, JW Pharm has the expertise and experience in both API and FDF. In 1991-2002, it held as the licensor from the originator in Korea (Tienam – Imipenem Cilastatin). And 2002 onward, JW launched their own product under the brand “Prepenem”, and until now is the leading product in the Korean market. And how did they do it? As mentioned above, JW differentiates their products by giving a safer product to the patients and meeting the 4 (four) quality assessments as above.

Currently in Carbapenem products, JW Pharm had launched Imipenem, Imipenem mixture, Meropenem, and Meropenem mixture, while Doripenem and Ertapenem are already in the pipeline. Some of the advantages that JW Pharm offers are the followings.

  • A proven track record of their API and FDF of Carbapenem.[3] If you would like to have a comparison study between JW’s and other manufacturers, please ask us further.

  • JW only uses Prep-LC in purification process while all others have conventional synthesis.
  • Fully dedicated plants for Carbapenem formulations and drug substance.
  • Superior quality compared to the originator.

So, the question is why do you settle for the less quality product if you could get a much better quality product with a competitive price? Don’t you want your generic drugs to be different than your competitors (plus it gives a safer products)? So, if you have further inquiry or would like to know how JW Pharm could assist you further, particularly for your Carbapenem products, please contact us further.

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Note :

[1] http://www.wikipedia.org and http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143545.htm

[2] JW Pharmaceutical Presentation (30 May 2012)

[3] FCD Comparison test sponsored by MSD, conducted by C. James Kirkpatrick MD, PhD, DSc, FRCP at Repair Lab. Johannes Gutenberg University GERMANY, presented at a Seminar in Singapore in 2010