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.

1,100m³+

Total Production Capacity (860m³

Actual Usable Production Capacity)
13,000m²

Laboratory Area
800+

Employees Worldwide
920

Clients
11

Certificates (US-DMF, EU-GMP, WHO-PQ , CEP)
26

Passed Inspections (FDA, EDQM, WHO,ANVISA,MFDS, NMPA, etc.)
400+

Customer Audits

Langhua Pharmaceutical
R＆D Center

Solution ＆ Service

Small Molecule CDMO

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Peptide CDMO

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API & Intermediates CDMO Service

Drug Product CDMO Service

Peptide CDMO Service

Analytical Service

Support

API & Intermediates CDMO Service

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 CDMO Service

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

CMC Development

Clinical Research

We can supply non-GMP and GMP peptide APIs from gram to multi-kilogram scales.

Custom peptide synthesis services
Cosmetic peptide products
Amino acid derivatives
Peptide fragments

Services

RS (Reference standards)
Analytical services
Process development and/or optimization
Validation
Regulatory support

Commercial Products

Non-GMP products
GMP products

Analytical Service

API Analysis Service
Pre-formulation Analysis Service
Drug Product Analysis Service
Stability study
Data Integrity

Support

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.