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

China APAC

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

As one of Huiyu Pharmaceutical s three core facilities alongside our R&D Center and API Manufacturing Site the Formulation Manufacturing Site is dedicated to the development and production of complex and high-value dosage forms.

About the plant

Huiyu Pharma’s Formulation Manufacturing Site features 15 advanced production lines capable of handling vial sizes from 2 mL to 100 mL, with preparation tanks ranging from 3 L to 5,000 L. The facility is designed to safely and efficiently manufacture high-potency (OEB5), oncology, cytotoxic, and hormonal products, ensuring compliance with the highest standards of safety and quality.

The site offers a broad range of technology platforms, including:

Long-acting implants
Microspheres
Nanocrystals/nanoparticles
Liposomes
Albumin-bound formulations
Injectable gels

It supports multiple injectable dosage forms such as:

Pre-filled syringes
Injection pens
Cartridges
Vials

The facility also provides a full suite of manufacturing capabilities, including:

Aseptic filling
Terminal sterilization
Sterile powder filling
Lyophilization (freeze-drying)
Oral solid dosage production (tablets, capsules)

The site operates in compliance with major global regulatory standards and has been approved by health authorities including China NMPA, US FDA, UK MHRA, EU EMA, Japan PMDA, Korea MFDS, South Africa SAHPRA, Portugal Infarmed, and Finland Fimea, among others.

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

Implants, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Injectables, Tablets, Hard capsules, Granules / Pellets, Powders, Lozenges, Terminal sterilization, Fill&Finish, Bottles, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS, SERVICES 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, (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

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

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