Zhejiang Langhua

Zhejiang Langhua Pharmaceutical Co., Ltd is a comprehensive pharmaceutical company engaged in the research, development, production, marketing, and sourcing of pharmaceutical products.​

Founded in 1986, Zhejiang Langhua Pharmaceutical Co., Ltd has evolved into a leading pharmaceutical enterprise. As a subsidiary of Viva Biotech Holdings, a prominent entity in innovative drug discovery, Langhua offers global partners a one-stop Contract Development and Manufacturing Organisation (CDMO) solution. This encompasses the entire lifecycle of small molecule Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDF), from pre-clinical stages to commercial supply. The company's facilities are strategically located in the Zhejiang Provincial Chemical and Medical Material Base in Linhai, covering an area of 190,000 square metres and employing over 500 professionals. Langhua has established a robust quality system, having successfully passed inspections from various international authorities, including the US FDA, EDQM, WHO, ANVISA, PMDA, and NMPA. ​

Key Products and Services:

API & Intermediates CDMO Service:

Process Development Service: Expertise in synthesis route design, development and optimisation, Quality by Design (QbD) studies, and process validation.​

Manufacturing Service: Comprehensive production capabilities for APIs and intermediates.​

Process Safety Assessment Service: Ensuring safety and compliance in all manufacturing processes.​

Drug Product CDMO Service:

Pre-clinical Drug Product R&D Service: Services including salt and polymorph screening, new chemical entity characterisation, and pre-clinical formulation development.​

Clinical Drug Product R&D Services: Formulation development and optimisation for clinical trials.​

Clinical and Commercial Drug Product Manufacturing Services: Scalable manufacturing solutions from clinical to commercial stages.​

Global Regulatory Submission Services: Support in navigating the complexities of global regulatory requirements.​

Analytical Service:

API Analysis Service: Comprehensive analysis ensuring the quality and integrity of APIs.​

Pre-formulation Analysis Service: Assessing the physicochemical properties of drug substances.​
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Drug Product Analysis Service: Ensuring the quality and consistency of finished dosage forms.​

Stability Study: Evaluating the shelf-life and stability of pharmaceutical products.​

Data Integrity: Maintaining the highest standards of data accuracy and reliability.​

Support Services:

Global CMC Filing: Assistance with Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions.​

Project Management: Coordinated oversight ensuring project milestones are met efficiently.​

Product Lifecycle Management: Strategies to manage the entire lifecycle of pharmaceutical products effectively.​

Zhejiang Langhua Pharmaceutical Co., Ltd is committed to advancing human health through innovation, quality, and sustainability. By integrating cutting-edge research and development with stringent quality management, Langhua strives to be the preferred partner in the global pharmaceutical industry, delivering value and excellence across all stages of drug development and manufacturing.