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About Langhua

Zhejiang Langhua Pharmaceutical Co., Ltd, is a comprehensive pharmaceutical company engaged in research and development, production, marketing, and sourcing of pharmaceutical products. As the subsidiary of Viva Biotech Holdings, the leading enterprise in the field of innovative drug discovery, we offer our worldwide partners a One-Stop CDMO solution in new drugs’ entire life cycle for small molecule Active Pharmaceutical Ingredients (APIs) and Finished Dosage Form (FDF), from pre-clinical to commercial supply. Langhua is the leading manufacturer of Spironolactone, Olanzapine, Antivirus, and fluoroquinolones in the world, and offers our global customers high-quality and competitive Generic APIs.

Ningbo Nuobai Pharmaceutical Co., Ltd, formerly a pharmaceutical division of Ninhua Group Ltd, now is the subsidiary company of Langhua Pharma since 2018. Nuobai Pharm focuses on the marketing and sourcing of pharmaceutical products including Intermediate, APIs, Preparation, and medical devices. The professional team with 30 years of sourcing and marketing experience, established strong partnerships with the reliable supplier in China. Product quality and business sustainability are the priori considerations in business. We commit to searching and recommending reliable & competitive sources to our customers to ensure long-term sustainable supply.

With the advanced technology platform, US-FDA / NMPA / EDQM / PMDA / WHO / ANVISA approved manufacturing site and robust EHS system, we have 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 and affordability, and quick access to the public.

Corporate Culture

Mission

Contribute to healthcare by supporting the improvement of medicine's availability and affordability.
Vision

To be the most valuable and preferred innovative API manufacturer and CDMO partner.

400+

Customer audit
4

CEP certificates
14

Passed FDA, EDQM, WHO, ANVISA, PMDA, NMPA, etc. Inspections
2

WHO-PQ Certificates
2

EU-GMP Certificates
3

US-DMF

Business Layout

Langhua's innovative R&D network spans three strategic centers situated in Shanghai, Ningbo, and Taizhou, collectively offering over 13,000 square meters of advanced lab facilities. Our dedicated team of two hundred chemists, with over half holding esteemed PhD or Master's degrees, is well-equipped to drive breakthroughs in new drug development and CMC filing. Our field leaders bring a wealth of experience from renowned global pharmaceutical corporations, specializing in APIs & Drug Product development, scale-up processes, and expertly navigating IND & NDA filing procedures.

Our R&D centers are outfitted with cutting-edge lab equipment and analytical instruments, including NMR (Bruker-400 MHz), LC-MS (Agilent), TOF-MS (Agilent), SFC (Waters UPC2), GC-MS/MS (Waters), GC-MS/MS (Agilent), ICP-MS, LC-CAD, XRPD, IR, UPLC, and more. These state-of-the-art tools not only meet stringent regulatory standards but also play a pivotal role in driving effective API and Formulation development.

R&D Centers
Manufacturing Site

Zhoupu, Shanghai

Process chemistry labs: 4,500㎡
Formulation labs: 2,500㎡
Analytical labs: 3,000㎡
Comprehensive CMC services from Preclinical Candidate (PCC) to New Drug Application (NDA) filing
GMP pilot plant equipped with Grade D Cleanrooms for APIs
Non-GMP Kilo Labs
GMP pilot plant equipped with Grade D Cleanrooms for formulation
Small-scale and pilot-scale formulation R&D labs

Taizhou, Zhejiang

Process chemistry labs: 2,500 ㎡
cGMP Kilo Labs
GMP pilot plant equipped with a Grade D Cleanroom
Focusing on process optimization, scaling up
API manufacturing supporting clinical trials

Ningbo, Zhejiang

Process chemistry labs: 1,300 ㎡
C-NAS accredited safety assessment lab

Taizhou, Zhejiang

Located in National Chemical and Medical Materials Base Linhai Zone, Taizhou, Zhejiang, P.R.
Factory area: 49.4 Acres; Building area: 40,000㎡
Reactors from 50L to 12,000L can handle various reactions including low temperature (-80℃) to high temperature (+250℃), GMP hydrogenation reactors from 200L to 1,500L can perform high-pressure hydrogenation reactions (up to 9.9 Mpa)
12 cGMP manufacture workshops with the scale of KG to Tons specialized/multi-functional/pilot plants
Total reactor volume: 1,000m³, the new plant under construction will increase the total reactor volume to 3,000m³ within 3 years
National high-tech enterprise and provincial enterprise research institute