CDMO R&D and Production Services
One-Stop Solution for Small Molecule Drug CDMO

Leveraging the technical advantages in Structure-Based Drug Discovery (SBDD), Viva provides leading CRO drug discovery services and CMC/CDMO services throughout the whole drug production process to global biopharmaceutical clients. Zhejiang Langhua Pharmaceutical Co., Ltd, a Viva Biotech Holdings subsidiary, is a comprehensive pharmaceutical company engaged in drug research, development, and production. Langhua helps offer our worldwide partners a one-stop CDMO solution in new drugs' entire life cycle for small molecule Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF), from pre-clinical to commercial supply.

With the advanced technology platform, US-FDA/NMPA/EDQM/PMDA/WHO/ANVISA approved manufacturing site, and robust EHS system, we contributed to more than 20 new drug launches in the past years and ensured long-term and sustainable supply of our outstanding services and products to our global partners. We are committed to being the most innovative, reliable CDMO service provider in the world, contributing to new medicine's availability, affordability, and quick access to the public.

  • 910m³+

    Production capacity

  • 13,000

    Laboratory area

  • 300

    Scientists and R&D staff

  • 788

    Clients

  • 11

    11 Certificates

    (US-DMF, EU-GMP, WHO-PQ, CEP)

     

  • 14

    14 Passed Inspections

    (FDA, EDQM, WHO, ANVISA, PMDA, NMPA)

  • 400+

    Customer audits

  • Langhua Pharmaceutical
  • R&D Center
Solution & Service
  • API Services
    We offer integrated services to worldwide partners for small molecule Active Pharmaceutical Ingredients (API) from pre-clinical to commercial supply.

    Synthetic route design and selection

    Process development & optimization

    Tox batch manufacturing

    API analytical method development and validation

    API stability study

    GMP manufacturing for Phase I, II and III clinical trials

    Scale-up and commercial manufacturing (mg to 1000 ton)

    API CTD document preparation for IND and NDA filings

  • Drug Product Services
    We provide formulation development and production services from preclinical to clinical phase Ⅱ.

    Pre-formulation study

    Formulation & process development

    Various dosage form development

    DP analytical method development and validation

    DP stability study

    GMP manufacturing for Phase I and II  clinical trials

    DP CTD document preparation for IND and NDA filings

  • Analytical Services
    We provide a full range of pharmaceutical analysis services to global clients.

    API Analysis Service

    Pre-formulation Analysis Service

    Drug Product Analysis Service

    Stability study

    Data Integrity

  • Support
    We have an experienced registration team to provide global clients with CMC filing , global filing registration support and other services.

    Global CMC Filing

    Project Management

    Product Lifecycle Management

  • Reliability
  • Flexibility
  • Efficiency
  • Innovation
Compliance
GMP Compliance is our 'Bottom Line'; EHS Compliance is Our 'Red Line'; Information&IP Protection is Our 'Life Line'.
  • GMP System

    In compliance with cGMP and ICH guidelines, Langhua establishes a robust quality system and maintains a good track record.

  • EHS System

    Following the requirements of ISO 14001, ISO 45001, and applicable national laws and standards, we established our EHS system to meet the requirements of the rules and regulations.

  • IP Protection

    Langhua commits to protecting customers' confidential information and intellectual property strictly.

To learn more about CDMO R&D and Production ServicesPlease visit Langhua's website

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