CDMO Services - CDMO Services

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.

860m³+

Production capacity
13,000m²

Laboratory area
689

Scientists and R&D staff
885

Clients
11

Certificates

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

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.