Pharmaceutica Analytica Acta

Santosh Narla

Publications

• Commentary
  API Supplier Change or Addition of Alterate API Supplier in Generic Drug Products: Cost, Quality and Regulatory Factors
  Author(s): Useni Reddy Mallu, Arunkanth Krishnakumar Nair, Hanimi Reddy Bapatu, Pavan Kumar M, Santosh Narla, Jonna Sankar, Tejas, Narendra Kumar Thamma and NVVSS RamanUseni Reddy Mallu, Arunkanth Krishnakumar Nair, Hanimi Reddy Bapatu, Pavan Kumar M, Santosh Narla, Jonna Sankar, Tejas, Narendra Kumar Thamma and NVVSS Raman
  
  Generic drug product (GDP) competition for market existence and profitability has become a challenging task for the manufacturers. All the generic players are putting intensive efforts to enter the market with competitive price and consistent drug product (DP) quality. The generic firms have to manage the delicate balance between the cost and quality of raw materials, especially the active pharmaceutical Ingredient (API) for market survival. Major Pharma companies have adopted the merger and acquisition strategies with API manufacturers to withstand the competition and price erosion. Still the majority firms don’t have their own API manufacturing facility. Since the finished product cost is majorily driven by API, the supplier selection plays prominent role in the generic profitability as well as quality. The supplier screening and selection includes extensive evaluation and com.. View More»
  DOI: 10.4172/2153-2435.1000364

  Abstract PDF