R&D and Production-Hebei Kaiwei Hengcheng Pharmaceutical Co., Ltd

河北凯威恒诚制药有限公司

R&D and Production

Zhangjiakou R&D Center

The R&D center covers an area of over 1400 square meters, with small molecule drug raw material research and development platform and injection research and development platform, and is equipped with a complete analysis method research platform (covering CMC quality research, stability investigation, and methodological verification).
The R&D center is equipped with internationally advanced scientific research equipment, including the Corning high-throughput microchannel reactor from the United States (which has advantages such as millisecond level mixing, precise temperature control ± 0.5 ℃, and mass transfer efficiency more than 10 times higher than traditional reactors, especially suitable for the development of high-risk/strongly exothermic reaction processes), which can replace traditional batch reactions and achieve seamless scaling from laboratory to industrial production. The R&D center has rich experience in the research and development of active pharmaceutical ingredients, injections, and solid formulations, and has experience in drug registration and application that meets the standards of the US FDA, EU EMA, and China NMPA.

Entrusting production partners

Hebei Kaiwei Hengcheng Pharmaceutical Co., Ltd. relies on a mature and compliant entrusted production cooperation system, focuses on its core advantages, and achieves efficient resource allocation.
Its entrusted production enterprises, Hebei Kaiwei Pharmaceutical Co., Ltd. (referred to as Kaiwei Pharmaceutical) and Hebei Kaiwei Kangling Pharmaceutical Co., Ltd. (referred to as Kaiwei Kangling), have standardized production workshops, professional production line equipment, mature quality control systems, and one-stop commissioned processing (CMO/CDMO) platforms, providing hardcore production capacity support for the large-scale production, compliant mass production, and stable delivery of Kaiwei Hengcheng's entire product line.

Production Workshop

Solid preparation workshop

The OSD workshop owned by Kaiwei Kangling is designed and constructed in accordance with FDA and EU standards, and passed the US FDA certification standard with zero defects in June 2024. The workshop adopts high-end equipment configuration from Xinma Pharmaceutical, covering advanced production processes such as wet granulation, dry granulation, and dry powder direct pressing. It can efficiently produce capsule formulations (including hard capsules, sustained-release capsules, enteric coated capsules, etc.) and tablets (such as ordinary tablets, film coated tablets, dispersible tablets, sustained-release tablets, etc.), and is equipped with fully automatic bottling lines (several granule bottling) and aluminum-plastic packaging lines (blister molding), fully meeting the needs from pilot research and development to commercial production. At the same time, it has special production capabilities for precious fine drugs (high activity, high added value).
Soft Capsule Workshop

The soft capsule workshop owned by Kaiwei Kangling is equipped with advanced fully automatic drip production lines, mainly used for producing a series of independently held products, including vitamin D2 soft capsules, vitamin AD soft capsules, vitamin E soft capsules, etc. Among them, compound clenbuterol hydrochloride soft capsules are the exclusive variety in China. This production line strictly follows GMP standards, adopts mature drip process technology, and is equipped with a sound quality control system, which can accurately adapt to different product characteristics and meet high standard formulation production requirements.

Small volume injection workshop

The small volume injection workshop owned by Kaiwei Pharmaceutical has nearly 50 years of professional experience in the production of small volume ampoule water injection. There are currently 4 production lines, including 1 sterile filling production line and 3 terminal sterilization production lines, which can meet the production of small volume injections of different specifications from 1ml-20ml. The fully sterile ampoule filling line equipped in the workshop has a fully sterile concept and technology that is at the forefront of the industry. The current products cover more than 10 categories of treatment fields, including gastrointestinal tract, cardiovascular and cerebrovascular diseases, nonsteroidal anti-inflammatory drugs, vitamins, antibiotics, respiratory system, etc.
API Workshop

The raw material workshop owned by Kaiwei Kangling is equipped with two flexible production lines, with the ability to produce raw materials ranging from tens of grams to tens of kilograms. It can provide pilot synthesis, validation production, and registration and approval of raw materials for formulation research and development, achieving one-stop services from process development to registration and application.

CDMO platform

Kaiwei Pharmaceutical and Kaiwei Kangling have a CDMO platform for small volume injections and solid preparations, which can provide "one-stop" services including drug research and development, pilot scale-up, process validation, and commercial production.

The small volume injection workshop is equipped with a patented fully sterile filling system
The small volume injection workshop is equipped with the ability to produce micro content small water injection preparations
High value-added solid dosage form production workshop
API production workshop and raw material factory

Hebei Kaiwei Hengcheng Pharmaceutical Co., Ltd.

Service Hotline

+86 313 5800215

+86 313 5906996

Shalingzi Town, Xuanhua County, Zhangjiakou City, Hebei Province (Dongshan Industrial Cluster Area)