CARBOGEN AMCIS | Shanghai, China

China APAC

CARBOGEN AMCIS | Shanghai, China

Large scale manufacturing.

About the plant

Shanghai

Large scale manufacturing

Shanghai, the largest economic and trade center in China, contains our fully self-supporting GMP compliant development and production site. Our facility is located in the Shanghai Chemical Industry Park (SCIP) and is designed for large scale manufacturing of raw materials, intermediates and API.

The site is equipped with 13 reactors, segregated into 4 separate suites and has reactor capacities from 500 L to 6300 L. With an international team of highly qualified specialists, our facility can provide efficient and scalable solutions to customers globally.

Activities

Large scale manufacturing of raw materials, intermediates and API
Capable of manufacturing highly potent chemicals up to category 3
Analytical capabilities allow GMP product release and analytical support for development activities

Certifications

ISO
EMA (EU GMP)
World Health Organization (GMP / HACCP)
NMPA (China GMP)
MFDS/KFDA (Republic of Korea GMP)
PMDA/MHLW (Japan GMP)
MHRA (UK GMP)
NSF

Activity

CHEMICAL-SYNTHETIC, SERVICES, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients) manufacturing

Features

Uses:
Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
DEA: N/A
BSL:
Therapeutic areas: N/A
Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), MFDS (South Korea), Turkish Health Authorities

Batch Size / Reactor

Services

Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, DMF (Drug Master File) preparation and submission

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