CDMO-A trustworthy health business in the Chinese world-Suzhou Chung-Hwa Chemical&Pharmaceutical Industrial Co.,Ltd.

CDMO Overview

Suzhou Chung-Hwa Chemical & Pharmaceutical CDMO focuses on the research and production of small trial batches, pilot batches, validation batches and commercial batches of drugs. With more than 30 years of pharmaceutical enterprise background and accumulated pharmaceutical experience, it has formed the core advantages of excellent system, legal compliance, and combination of quality and cost, and has established a customer-centric and quality-based service principle, and is committed to providing customers with professional customized drug preparation R&D and production services.
Suzhou Chung-Hwa Chemical & Pharmaceutical has nearly 20 years of OEM experience at home and abroad, and has established cooperative relationships with more than 20 customers at home and abroad (commissioned approval, commissioned production and export), involving more than 40 specifications, covering China, Japan, Africa, the Philippines, Vietnam, Myanmar, Hong Kong and other countries and regions, and has been highly praised.

After passing the inspection and certification of PMDA of Japan in 2009, we officially started the road of customized R&D and production for Japanese pharmaceutical companies, which was well received by customers and continuously expanded the scope of business cooperation.

Since the introduction of the MAH system in 2019, we have successfully provided pilot batches, validation batches and commercial CDMO and CMO professional services to many well-known domestic companies, which have been fully recognized by customers.

Production Line Introduction

Workshop	Production line	Annual production capacity (billion)	Packaging form	Key equipment and processes
Cephalexin powder injection workshop	Powder injection production line	0.6	Vials 7ml, 12ml, 20ml	German BOSCH airflow powder filling machine
Cephalosporin oral solid workshop (Collective procurement winning variety workshop)	Tablet production line	4	Hard double aluminum packaging, aluminum-plastic packaging, bag packaging	Dry granulator, wet mixing granulator, high-efficiency coating machine
	Capsule production line	12
	Granule production line	2.5
Non-cephalosporin oral solid workshop (has passed Japan PMDA certification) (Central procurement winning product workshop)	Tablet production line	16	Hard double aluminum packaging, aluminum plastic packaging, bottled, bagged	Osmotic pump controlled release platform: laser drilling machine, multi-layer tablet press Micropellet process: bottom spray-multi-function fluidized bed Tablet appearance inspection: Japanese VISWILL appearance inspection machine (Tablet + powder) Capsule process: Xinma multi-function filling machine Centrifugal spray granulator
	Capsule production line	8
	Granule production line	1.5
Contact lens care solution workshop	Care solution production line		Bottle

Factory advantages

The company has A, B and C certificates. The core management team has more than 20 years of experience in pharmaceutical research and development and production quality management and more than 10 years of experience in entrusted production. They are familiar with the entrusted and entrusted business processes under the MAH system and can effectively identify and control risks in product transfer, amplification, verification and commercial production.
With a good foreign investment foundation and long-term international cooperation, we have been given the impetus and technical support to continuously improve quality, achieving the perfect integration of international quality and local management.
The professional CDMO project management team makes project docking, communication, progress advancement, resource coordination, etc. more efficient.
The geographical location is superior and the traffic and transportation are very convenient.

Quality Introduction

The quality system complies with the requirements of China GMP and Japan PMDA. The laboratory has multi-dimensional testing capabilities, covering the three core testing areas of physics, chemistry and microbiology, with complete testing instruments, and has the ability to test APIs, excipients, packaging materials, intermediates and finished products (powder injections, tablets, capsules, granules), and can undertake stability studies.

Chromatographic instruments	GC, HPLC, UPLC of Waters, Agilent, and Shimadzu brands
Spectroscopic instruments	UV spectrophotometers, Fourier transform infrared spectrometers, atomic absorption spectrophotometers, and Raman spectrometers of Agilent, Shimadzu, and Thermo Fisher brands
Basic instruments	1/100,000 analytical balance, fully automatic sampling dissolution instrument, particle size tester, fully automatic burst strength tester, microcomputer edge pressure ring pressure strength tester and other testing instruments
Stability	Entry-type stability test chamber, constant temperature and humidity chamber, and equipped with temperature distribution verification and online temperature control system equipment
Microbiological laboratory	Double-door pulsating sterilization cabinet, laminar clean bench, biological safety cabinet, microplate reader, incubator, suspended particles, floating bacteria sampler, biological microscope

Stay tuned!

Stay tuned!