Welcome to Alban Pharma
Alban Pharma, registered in Hong Kong and operating in US, EU and China, is engaged in contract manufacturing for commercial and noncommercial (research and development,preclinical, clinical) scale production of APIs and Dosages, ANDAs and DMFs filling, compliance issue handlings including manufacturing site change, GMP nonconformance issues, GMP inspection etc. Alban Pharma adds not only the expertise but also the financial assurance to the client’s project to assure the successes of the projects...
News
- First Authorisation of Traditional Herbal Medicine from outside the European Union to A Chinese Company
- Zhejiang Hisoar passed Brazilian ANVISA official inspection successfully under guidance of NovoScience Consulting team!
- Zhejiang Xianju Xianle passed EDQM official inspection successfully under guidance of NovoScience Consulting team!
- NEPG passed FDA official inspection successfully under guidance of NovoScience Consulting team!
- HISOAR passed MHRA official inspection successfully under guidance of NovoScience Consulting team!
Contract Manufacturing Matchmaking
China is a major market for customized API manufacturing and an emerging market for dosage contract manufacturing with advantages and strengths in modern facilities, low costs, high efficiencies and great flexibilities. However, Western pharmaceutical contract project owners...
ANDAs and DMFs Filing
DMFs (Drug Master Files) and ANDAs (Abbreviated New Drug Applications) are critical documents for marketing authorization application and approval in US and EU markets. However, most contract manufacturers in China often do not have thorough and professionally...
GMP Management
Chinese new GMP, based on EU GMP guidelines, is implemented starting from March 1, 2011. The quality systems in pharmaceutical companies in China must meet the new GMP requirements by 2013 for sterilized pharmaceuticals and by 2015 for non-sterilized pharmaceuticals...