Sichuan Huiyu Pharmaceuticals Co., Ltd.

China APAC

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site

As one of Huiyu Pharmaceutical s three core sites, alongside the R&D center and formulation plant, our API manufacturing facility plays a vital role in our integrated supply chain.

About the plant

Huiyu Pharma API Manufacturing Site consists of 20 specialized workshops dedicated to the development and commercial production of a wide variety of active pharmaceutical ingredients (APIs).

Key capabilities include:

Oncology APIs
Cytotoxic APIs
High Potent APIs (OEB 5)
Sterile APIs
Automatic fermentation lines for biosimilars
Dedicated production areas for peptides and mRNA-based products

The reaction workshops are divided into large, medium, and small-scale production zones, along with classified clean areas to ensure flexibility and strict adherence to regulatory requirements. A dedicated strain cultivation room further supports fermentation and biologics manufacturing.

The facility supports batch sizes ranging from laboratory and pilot scale to full-scale commercial production. It is equipped with advanced systems, including MSGL, stainless steel, titanium, and glass reactors with volumes ranging from 100 L to 5,000 L.

Our technical capabilities cover a wide process range, including:

Ultra-low to ultra-high temperature reactions
Molecular and high vacuum distillation
Solvent recovery and waste treatment
Membrane-based gas separation
Hydrogenation

The site has successfully passed multiple production license inspections, covering China NMPA, EU EMA and US FDA, etc.

Certifications

ISO
EMA (EU GMP)
FDA (cGMP)
Health Canada (Canada GMP)
French Service-Public (CIR)
ECOVADIS
World Health Organization (GMP / HACCP)
NMPA (China GMP)
TGA (Australia GMP)
ANVISA (Brazil B-GMP)
Roszdravnadzor (Russia GMP)
ANMAT (Argentina nueva GMP)
MFDS/KFDA (Republic of Korea GMP)
PMDA/MHLW (Japan GMP)
ISP (Chile BPM)
INVIMA
MSPAS
COFEPRIS
DIGEMID
MHRA (UK GMP)
SQF (Safe Quality Food)
IFS
BRCGS
Halal Research Council
UAE Ministry of Health & Prevention
SFDA (Saudi Food & Drug Authority)
NSF
TITCK (Turkish Health Authorities)

Activity

CHEMICAL-SYNTHETIC, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Excipients, Radiopharmaceuticals, 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), 5 / HPAPI (PDE < 10 µg/day)
DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
BSL: 1, 2, 3, 4
Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (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), Russian Health Authorities, 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

Services

Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Genetic analysis & Pharmacogenetics, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) 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, Orphan Drug Designation Support, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, OSD (Oral Solid Doses) manufacturing, Fill and finish, Safety studies, Solid form selection, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis

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