News Headlines

  1. New Analysis Notes The Critical And Evolving Role Pharmaceutical Distributors Play In U.S. Healthcare

    A new report published by the Healthcare Distribution Alliance (HDA) and Deloitte Consulting LLP highlights the value distributors provide to the United States healthcare ecosystem and estimates pharmaceutical distributors generate between $33 and $53B in cost savings annually.

  2. Cambrex To Double Size Of Edinburgh Solid Form Screening Facility

    Cambrex Corporation, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, recently announced that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland, doubling the current footprint to 15,000 sq. ft.

  3. Merck Adding $680M, 425 Workers To North Carolina Vaccine Production

    North Carolina's global leadership in pharmaceutical manufacturing took another leap recently with Merck’s announcement that it will invest $680M in its two major facilities in Durham and Wilson and add at least 425 more workers to its North Carolina vaccine production workforce.

  4. FDA Announces New GDUFA Pricing

    The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2020 rates for GDUFA II fees.

  5. Olon S.p.A. Expands Microbial GMP Capabilities At Its Manufacturing Site In Capua

    Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, celebrates today the start of the construction of a new GMP manufacturing facility at its microbial CDMO facility located in Capua, Italy.

  6. Lonza Expands Bioconjugation Facility And Announces Approval Of Third Commercial ADC
  7. WuXi STA Shanghai & Changzhou Facilities Pass U.S. FDA Inspections

    STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou, have successfully passed two inspections from the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.

  8. Hikma And Civica Rx Sign Long-Term Agreement To Reduce Generic Drug Shortages In The US

    Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's / BB+ S&P, both stable), the multinational generic pharmaceutical company and Civica Rx (Civica, Inc.) today announce a five-year agreement to manufacture and supply Civica's growing membership of US health systems with medications that are often in short supply in US hospitals.

  9. Kite, A Gilead Company, Announces Plans For New 67,000-Square-Foot Cell Therapy Manufacturing Facility In CA; Dedicated To Viral Vectors

    Kite, a Gilead Company, recently announced plans for a new 67,000-square-foot facility in Oceanside, California, dedicated to the development and manufacturing of viral vectors, a critical starting material in the production of cell therapies.

  10. Pall Corporation Chosen As Single-Source Supplier By Servier For Purpose Built End-To-End Biomanufacturing Facility In Gidy, France

    Pall Corporation, a global leader in filtration, separation and purification, has been chosen by Servier, an independent international pharmaceutical company, as an exclusive technology and services provider for their Gidy, France biomanufacturing facility.