Kemwell Biopharma

Using Spectral Technology to Meet CGMP Guidelines in the Pharma Industry  Just like most other industries, technology plays a major role in the pharmaceutical industry, and to fulfil the standards and regulations that are needed for pharmaceutical products, they often use spectral technology. Each nation has its own body such as America’s Food and Drug Administration (FDA) to ensure that over-the-counter medication and prescription drugs are safe and effective for use.  Organizations like the FDA have set standards to assess the quality of pharmaceuticals using Current Good Bio Pharmaceutical CGMP Manufacturing Practice (CGMP) guidelines. Even if the consumers may not be aware, CGMPs help assess the processes carried out in pharmaceutical industries by emphasizing on the use of the latest technology for maintaining effectiveness and safety. Purpose of Current Good Manufacturing Practice CGMPs scrutinize each and every aspect of pharmaceutical productio...

The entry if new biosimilars in the market will not only reduce prices but also increase competition. This new development will help patients get access to innovative medication. However, regulatory burdens and high manufacturing costs make it difficult for biosimilar contract manufacturers to reduce prices to the same extent as generics. On the other hand, there is apprehension among biosimilar manufacturers that reducing prices significantly will eliminate the incentive for them to enter the biosimilar space. Addressing these difficulties presents an opportunity to lower drug costs and improve patient access. What’s the Current Practice? For outpatients, reimbursement for medicines administered by providers is based on the Average Sales Price. Medicare pays the provider Average Sales Price + 6% of the medicine. Due to the lag between published Average Sales Price data and product launch, payers depend on Wholesale Acquisition Cost until the Average Sales Pric...