Zhejiang Langhua Pharmaceutical Co., Ltd
Abstract: Owned by Ninhua Group Ltd., Zhe Jiang Langhua is an FDA approved APIs, intermediates manufacturer and customer preferred CDMO partner in China. With 30 years growth, Langhua has been the global leading company of quinolones, anti-virus, cardiovascular and anti-depressant APIs. Based on cGMP & ICH Guideline, Langhua established the robust quality system and passed FDA, WHO, EDQM, ANVISA and CFDA’s on-site inspections. 4 DMF were filed in USFDA. Langhua commits to be the customer-preferred APIs manufacturer and CDMO partner. Can provide One-stop Solution of product lifecycle management, including ROS development, process development & optimization, scale-up, registration & validation batch through to commercial batch production.
Description: Langhua robust GMP system can ensure the quality reliability for worldwide market, and the strong EHS system has became the benchmark in APIs industry in China. With the concept of “EHS by designâ€, langhua established the safety lab to ensure Risk-Free from lab, pilot to commercial production.
The sufficient capacity and new pilot, multifunction workshop will ensure the on-time delivery from KGs to Tons even hundred tons. Langhua respects customers’ IP and set up the IP protection policy to ensure Risk-Free of confidential information.
The experienced R&D team engages to apply new technologies to realize your idea, to optimize the process to make product affordable.
Langhua has a flexible, project-driven approach to each request, targeting a custom-made solution fit for your purpose and requirements. The workshops are classified to fit different requirements based on product classification, to achieve quick switch with the support of planning team.
The experienced management team with more than 30 years in API manufacture, combining the efficient project management programs, Langhua commits to the delivery of cost-effective project on time, on budget and to the expected quality standard. With the concept of “develop for production†and “Lab to Plant by same teamâ€, langhua ensures the 100% success of scaling up and commercialization.
Driven by reliability, flexibility, efficiency and innovation, Langhua continuously contributes to human health with improvement of medicine’s availability and affordability.
Services:
Process development for Small Molecules & Large Molecule Building Block
Pilot- Scale to Commercial-Scale Manufacturing
Category: Drug Product
Type: Small Molecules / Biologics
Contact: Ross Ji ([email protected])