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Pharma Forum 2018

The forum is back by demand due to successful turnouts in the past years in China and Singapore, having on … Keep Reading

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DuPont Nutrition & Health and Eurofins Bring Higher Level of Transparency to Probiotic Industry Through Genetic Identification

in Pharmaceutical News
DuPont Nutrition & Health and Eurofins Bring Higher Level of Transparency to Probiotic Industry Through Genetic Identification

DuPont Nutrition & Health and Eurofins have developed and validated strain-level identification assays in probiotic testing, leading the way for industrywide product integrity and label accuracy. DuPont, a leading manufacturer of probiotics that are scientifically proven to have health benefits, routinely utilizes new technologies to improve its methods of strain identification. Eurofins will employ DuPont’s polymerase-chain-reaction (PCR) genotyping assays to identify probiotics at the strain level in both raw materials and finished products. An Industrywide Challenge The need for strain-specific…

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Korea finished drug market growth driven by generics

in Pharmaceutical News
Korea finished drug market growth driven by generics

The Korean pharma market is experiencing significant growth in finished drug products, according to CPhI Korea. Over the last 12 months, market conditions have spurred a strong expansion in exports of finished formulations, driven primarily by an expanding domestic generics market. South Korea’s domestic companies are transitioning quickly to an export-oriented stance. According to the Korean Pharmaceutical Traders Association (KPTA), the export of domestic finished products is growing with a total volume of $2.6 billion in 2017. Domestic APIs are…

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Method Transfer, Its Importance, Complexities, and Future Trends

in Pharmaceutical Articles
main steps during a method transfer

The USP chapter <1224> defines the method transfer or transfer of analytical methods (TAP) as a systematically documented process that allows a laboratory (receiving laboratory) to perform an analytical method that has been validated in another laboratory (source laboratory), hence ensuring that the new receiving laboratory has the knowledge, prowess, and resources to perform the transferred analytical method as intended. In contrast to analytical method validation, no detailed regulatory guidance exists for method transfer. Some high-level information is e.g. provided…

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