CHEMICAL-SYNTHETIC SERVICES in APAC

China APAC

CHEMICAL-SYNTHETIC SERVICES in APAC

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 multipled reactors, segregated into 5 separate suites and has reactor capacities from 50 L to 6300 L. With an international team of highly qualified specialists, our facility can provide efficient and scalable solutions to customers globally. The site has been approved by NMPA (Chinese Health Authority) and ANVISA (Brazilian Health Authority) .

Activities

Large scale manufacturing of raw materials, intermediates and API
Capable of manufacturing highly potent chemicals up to category 3 / OEB 4
Analytical capabilities allow GMP product release and analytical support for development activities

Compliance

NMPA (China GMP)
ANVISA (Brazil B-GMP)

Activity

CHEMICAL-SYNTHETIC, SERVICES, RSM (Raw Starting Materials), Intermediates, API (Active Pharmaceutical Ingredients), Excipients, Building Blocks manufacturing

Features

Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
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), 4 / HPAPI (PDE = 10 - 100 µg/day)
Controlled substance: N/A
BSL: N/A
Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), SFDA (Saudi Arabia), Turkish Health Authorities

Batch Size / Reactor

Small, Medium, Large, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L

Services

Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Clean room rental, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, 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, Parametric release, Primary packaging, Secondary packaging, Labeling, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug application) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Salt screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, Safety studies, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis