Zhejiang Langhua Pharmaceutical

What Zhejiang Langhua Pharmaceutical does

Zhejiang Langhua Pharmaceutical Co., Ltd. (浙江朗华制药有限公司) is a China-based pharmaceutical contract development and manufacturing organization (CDMO) founded in 1986 and headquartered in Linhai, Taizhou, Zhejiang. The company is a wholly-owned subsidiary of Hong Kong-listed Viva Biotech Holdings (1873.HK), acquired in 2020 as the manufacturing arm of Viva's integrated CRO-to-CDMO strategy. Langhua provides end-to-end small molecule drug development and manufacturing services, covering active pharmaceutical ingredients (APIs) and intermediates, finished drug products, and peptides, serving both innovative drug developers and generic pharmaceutical companies globally. As of FY2023 the company reported revenue of RMB 1,310.7 million and served approximately 880 clients, with the top ten clients accounting for 51.2% of revenue.

Langhua's technical platform is anchored by proprietary green chemistry capabilities — including enzymatic synthesis/biocatalysis, modular continuous flow processing (including commercial-scale microchannel reactors), a ~200m² catalyst and ligand screening laboratory, asymmetric catalysis, photochemistry, and electrochemistry — alongside comprehensive drug product technology platforms covering oral, topical, pediatric, and liquid (including injectable) dosage forms, with particular depth in poorly soluble drug solubilization. The company operates 12 cGMP manufacturing workshops with 1,100m³ total reactor volume (860m³ usable), temperatures from -80°C to +250°C, and pressure capability up to 9.9 MPa, supported by ~13,000m² of laboratory space across R&D centers in Shanghai, Taizhou, and Ningbo. Regulatory credentials include 11 formal certificates (3 US-DMF, 2 EU-GMP, 4 CEP, 2 WHO-PQ) and a track record of 26 successful inspections by FDA, EDQM, WHO, ANVISA, MFDS, and NMPA, plus ISO 14001/45001, PSCI, and EcoVadis Bronze.

Langhua generates revenue through project-based, milestone- and batch-billed CDMO contracts covering API process development and manufacturing, formulation development and commercial supply, peptide CRDMO, analytical and CMC regulatory services, and direct sales of 17 self-developed generic APIs (including fluoroquinolones, spironolactone, and olanzapine). The go-to-market model combines dedicated business development teams, conference presence (CPHI, PharmaCon, CIS-Asia), and approximately 69% of orders sourced through the parent Viva Biotech CRO/incubation client funnel. The company is currently executing a roughly USD 150 million capex program to add four new multifunction workshops and expand reactor volume to 1,500m³ within three years, alongside a peptide CDMO service built around GLP-1 readiness and oral peptide delivery. Ningbo Nuobai Pharmaceutical, a wholly-owned subsidiary acquired in 2018, provides international marketing and sourcing reach with 30+ years of trade experience.

Name

Zhejiang Langhua Pharmaceutical

Legal name

浙江朗华制药有限公司 (Zhejiang Langhua Pharmaceutical Co., Ltd.)

Website

https://langhuapharma.com

Company type

Private

Founded year

1986

Operating status

Operating

Headcount range

51–100 employees

Short description

Zhejiang Langhua Pharmaceutical is a China-based CDMO providing end-to-end small molecule drug development and manufacturing services—from APIs and drug products to peptides—for global innovator and generic pharmaceutical clients. It operates as the manufacturing arm of Viva Biotech Holdings' integrated CRO-to-CDMO platform.

Ownership category

akta.pro rank

Product category

Pharmaceutical CDMO (Contract Development and Manufacturing)

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412), Medicinal and Botanical Manufacturing (325411), Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Pharmaceutical Preparations (2834), Medicinal Chemicals & Botanical Products (2833), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Small-Molecule API & Intermediates CDMO (HLAGABAA), Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Small-Molecule API Commercial Manufacturing (HLAGAHAB), Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM), Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI)

Keywords

• Pharmaceutical CDMO services
• API manufacturing
• Drug product development
• Peptide CRDMO services
• CMC regulatory filing

Headquarters

HQ city

Taizhou

HQ country

China

HQ region

Asia

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain, Marketing or Sales

Revenue model

1. CDMO Services (API & Intermediates): Contract Development and Manufacturing Organization services for active pharmaceutical ingredients and intermediates, covering process development, manufacturing, and regulatory support from preclinical through commercial stages. Revenue generated through project-based contracts, typically billed by milestone, batch, or annual supply agreements.
2. Drug Product CDMO Services: Formulation development and manufacturing services for finished dosage forms including tablets, capsules, injectables, and topical formulations from clinical through commercial supply.
3. Peptide CDMO Services: Peptide CRDMO services including discovery support, process development, GMP manufacturing, and regulatory filing for peptides, proteins, and oligonucleotides.
4. Analytical Services: Comprehensive analytical testing services including method development, validation, quality control, and stability studies for APIs and drug products.
5. Generic API Sales: Direct sales of generic active pharmaceutical ingredients including Ciprofloxacin HCl, Enrofloxacin, Levofloxacin, Spironolactone, Olanzapine, and others to global pharmaceutical customers.
6. CMC Services: Chemistry, Manufacturing and Controls services including regulatory filing support for IND/CTA, NDA/MAA, and ANDA submissions globally. Revenue of ~RMB 56.7 million as of end of 2023 reporting period.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Zhejiang Langhua Pharmaceutical is an integrated pharmaceutical CDMO providing one-stop small molecule drug development and manufacturing services from preclinical through commercial supply. Its offerings span four core service lines: API & Intermediates CDMO, Drug Product CDMO, Peptide CRDMO, and Analytical Services, supplemented by CMC regulatory filing, project management, and product lifecycle management services. The company also directly sells a portfolio of 17 self-developed generic active pharmaceutical ingredients (Ciprofloxacin HCl, Enrofloxacin, Levofloxacin, Spironolactone, Olanzapine, and others).

Product overview

Zhejiang Langhua Pharmaceutical is a comprehensive pharmaceutical CDMO providing one-stop solutions for small molecule drug development from preclinical to commercial supply. The company operates as a platform-plus-services model comprising four core service lines: API & Intermediates CDMO Service, Drug Product CDMO Service, Peptide CDMO Service, and Analytical Service, supported by CMC Registration, Project Management, and Product Lifecycle Management services. The technology infrastructure is built on Green Chemistry Technology Platform (including Enzymatic Synthesis, Continuous Flow Process, and Catalyst Screening sub-platforms), Drug Product Technology Platform, and specialized dosage form capabilities (Pediatric, Oral, Topical, Liquid forms, and Poorly Soluble Drug Solubilization). The company also offers a portfolio of 17 self-developed generic APIs including fluoroquinolones, spironolactone, and olanzapine. As a subsidiary of Viva Biotech Holdings, Langhua leverages shared technology platforms for peptide development and protein-related services.

Differentiator

Problem solved

Functional benefit

Products and services

• API & Intermediates CDMO Service Comprehensive contract development and manufacturing organization service covering process development, synthesis route design, optimization, QbD studies, process validation, manufacturing, and process safety assessment for active pharmaceutical ingredients and intermediates.
• Drug Product CDMO Service End-to-end formulation development and manufacturing services including preformulation studies, salt/polymorph screening, clinical formulation development, clinical and commercial drug product manufacturing, and global regulatory submission support.
• Peptide CDMO Service Comprehensive peptide CRDMO service powered by AI-driven design and lab-in-the-loop druggability profiling, enabling seamless scale-up from mg to thousand kg using hybrid SPPS/LPPS and continuous flow technologies, with GLP-1 readiness and oral peptide delivery expertise.
• Analytical Service Comprehensive drug analysis services including API analysis, preformulation analysis, drug product analysis, stability studies, and data integrity management to support global regulatory filings.
• CMC Registration Service Global regulatory affairs service providing CMC consulting, document preparation, and regulatory submissions for IND/CTA, NDA/MAA, and ANDA across US, Europe, Japan, WHO, China, and other countries.
• Project Management Service Coordinated project management with dedicated project leaders and technical experts, real-time progress tracking, weekly reporting, and comprehensive project documentation.
• Product Lifecycle Management Service Continuous process improvement, supply chain risk management, vendor qualification, and next-generation process development for sustained product availability throughout the drug lifecycle.
• Self-Developed Generic APIs Portfolio of 17 generic active pharmaceutical ingredients including Ciprofloxacin HCl, Enrofloxacin, Levofloxacin, Spironolactone, Olanzapine, and others, available in non-patent protected regions.

Quantifiable outcome

• Served 880 total clients with 100% retention rate of top ten clients as of end 2023
• +5 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature10 records

Partnerships

Five partnerships are on record, tiered flagship, minor and core.

• LonzaflagshipStrategic or Co-development Partner · 20 March 2024Viva Biotech (parent company) entered into a licensing agreement with Lonza for Lonza's bYlok® bispecific pairing technology, expanding Viva Biotech's large molecule capabilities and supporting bispecific antibody design and production. This partnership enhances the integrated CRO-CDMO service offering.
• 宁波诺柏医药有限公司 (Ningbo Nuobai Pharmaceutical Co., Ltd.) / NingboTech UniversityminorOthers · 5 November 2021Industry-education integration partnership with NingboTech University to establish practice base for talent cultivation and joint development programs.
• 台州大学医药化工与材料工程学院 (Taizhou University - Pharmaceutical, Chemical and Material Engineering College)minorOthers · 4 November 2021Provincial-level industry-education integration practice base established with Taizhou University's Pharmaceutical, Chemical and Material Engineering College, involving joint talent cultivation and practical training programs. R&D Director, Quality Director, and department managers serve as part-time university teachers.
• 宁波诺柏医药有限公司 (Ningbo Nuobai Pharmaceutical Co., Ltd.)coreOthers · 1 January 2018Ningbo Nuobai Pharmaceutical Co., Ltd., formerly the pharmaceutical division of Zhonghua Group (中宁化集团), became a wholly-owned subsidiary of Langhua Pharmaceutical in 2018. Nuobai specializes in marketing and sourcing of pharmaceutical intermediates, APIs, preparations, and medical devices with 30+ years of international market experience, providing Langhua with established global commercial distribution capabilities.
• VivaVision (Viva Biotech Incubation Portfolio)coreStrategic or Co-development PartnerVivaVision is a key invested and incubated company of Viva Biotech focusing on ophthalmic innovative drug R&D. Langhua provides CMC/CDMO services for VivaVision's VVN001 (Phase II dry eye treatment). This represents the vertical client diversion effect of Viva Biotech's integrated CRO-to-CDMO strategy, with Langhua supporting clinical sample scale-up for multiple portfolio companies.

Scale indicators14 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Porton Pharma (博腾股份): Chinese small-molecule CDMO offering API, intermediates, and formulation services. Directly comparable to Langhua in scale, customer base (global innovative pharma), and CDMO service model.
• ChemPartner: China-based CRO/CDMO with small-molecule process development, API manufacturing, and formulation services. Overlaps with Langhua's preclinical-to-commercial CDMO positioning.
• Pharmaron: Integrated CRO/CDMO with small-molecule API and drug product CDMO services. Comparable to Langhua in offering end-to-end development and manufacturing for global pharma clients.
• Bachem: Swiss peptide and oligonucleotide CDMO leader. Directly comparable to Langhua's emerging peptide CDMO line, particularly for GLP-1 and complex peptide programs.
• Asymchem (凯莱英医药): Leading Chinese small-molecule CDMO with API, intermediates, and drug product services. Direct competitor to Langhua in API CDMO and drug substance manufacturing for global innovative pharma, with overlapping client base and similar technology platform focus.

Broad incumbents

• Lonza: Global CDMO leader in small molecules, biologics, and cell & gene therapies. Already partnered with parent Viva Biotech (bYlok licensing) and competes with Langhua for global pharma API/drug product CDMO work.
• WuXi STA (WuXi AppTec): Largest China-based CRO/CDMO with extensive small-molecule API and drug product CDMO capabilities. Langhua's most significant direct competitor with deeper modality coverage and global scale.
• Catalent (Novo Holdings): Global CDMO with extensive drug product, softgel, and biologics capabilities. Competes with Langhua's drug product CDMO line, particularly in oral solid and specialty dosage forms for global pharma.
• WuXi Biologics: Global biologics CDMO leader under the WuXi AppTec umbrella. Relevant as a sister-company competitor for parent Viva Biotech and as a peer in the broader Chinese CDMO landscape serving global pharma.

Emerging players

• Shanghai Medicilon: China-based preclinical CRO/CDMO with growing small-molecule capabilities. Comparable in size and emerging CDMO positioning, with potential overlap in API and drug product services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance15 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Zhejiang Langhua Pharmaceutical