CDMO Services - CDMO Services

Leveraging the technical advantages in the field of 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 subsidiary of Viva Biotech Holdings, is a comprehensive pharmaceutical company engaged in drug research, development and production. Langhua offers our worldwide partners One-Stop CDMO solution in new drug full life-cycle for small molecule Active Pharmaceutical Ingredients (APIs) and Finished Dosage Form, from pre-clinical to commercial supply.

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

670m³+

Production capacity
13,000m²

Laboratory area
200

Scientists and R&D staff
788

Clients
11

Got US-DMF, EU-GMP,

WHO-PQ, CEP certificates
14

Passed FDA, EDQM, WHO, ANVISA,

PMDA, NMPA etc. inspections
400+

Customer audit

Langhua Pharmaceutical
R＆D Center

Solution ＆ Service

APIs＆Intermediates CDMO Services

We offer worldwide partners integrated services for small molecule Active Pharmaceutical Ingredients (APIs) from pre-clinical to commercial supply.

Process Development

Manufacturing

Technology Platform

Process Safety Assessment
Drug Product CDMO Services

We provide formulation development and production services from preclinical to clinical phase Ⅱ.

Pre Clinical Drug Product R&D

Clinical Formulation Development Service

Drug Product Manufacturing

Technology Platform
Analytical Services

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

APIs 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

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&ICH Guideline, Langhua established robust quality system and maintained good track record.
EHS System

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

Langhua is committed to protect customer's confidential information and intellectual property strictly.