Sichuan Huiyu Pharmaceuticals Co., Ltd.

China APAC

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

As one of Huiyu Pharma s three core facilities, alongside the API Manufacturing Site and Formulation Manufacturing Site, the R&D Center plays a pivotal role in supporting the development of both APIs and finished dosage forms.

About the plant

Huiyu Pharma R&D Center plays a pivotal role in supporting the development of both APIs and finished dosage forms. This includes oral solids, lyophilized powders, pre-filled syringes, injection pens, and especially complex injectable formulations such as long-acting implants, microspheres, nanocrystals/nanoparticles, liposomes, albumin-bound drugs, and injectable gels.

Huiyu Pharma R&D Center is built upon three integrated technology platforms:

Generic Consistency Evaluation Platform

A scientific, comprehensive, and efficient system for injection consistency evaluation, encompassing project management, experimental research, technology transfer, and both domestic and international registration strategies.

API Quality Control and Production Technology Platform

This platform focuses on chiral drug development, crystallization and purification techniques, with strong expertise in oncology APIs, tumor adjuvant therapies, and contrast agents. It also extends to APIs in cardiovascular, anti-infective, and antibiotic areas.

Complex Formulation Process Control Technology Platform

Equipped to support advanced formulation development, this platform includes:
Polymer excipient preparation and purification
Continuous manufacturing for nanoscale formulations
Twin-screw hot melt extrusion
Online high-shear dispersion
Suspension-injection flow cell technology for dissolution control
Micelle-free drug quality control methods

Together, these platforms enable Huiyu Pharma to accelerate development timelines, ensure regulatory compliance, and deliver high-quality, complex pharmaceutical products to global markets.

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, Lyophilizates, Terminal sterilization, Fill&Finish, Bottles, Dropper bottles, Ophtalmic dispensers, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS, 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

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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