中文

MAH

The Marketing Authorization Holder (MAH) system refers to the system where non-manufacturing entities such as pharmaceutical research institutions and researchers, or pharmaceutical manufacturing companies, obtain relevant pharmaceutical technologies. They then apply for marketing authorization to become an MAH. The MAH can choose to manufacture the drugs themselves or entrust other pharmaceutical manufacturing companies to produce them. SkyRun Pharmaceutical Co., Ltd. has obtained a "Drug Manufacturing License" (B Certificate) as an MAH. This enables them to collaborate with CROs and CMOs/CDMOs and provide rich, flexible, and open cooperation strategies, granting their partners full product rights.

CRO

Consistency evaluation

Consistency

According to the principles outlined in the Technical Guidelines for National Consistency Evaluation, we offer consistency evaluation research services that include, but are not limited to: quality control of raw materials and packaging materials, selection and optimization of formulation processes, quality research and control, process scale-up and process validation, clinical bioequivalence studies, and more. We can provide comprehensive and standardized consistency evaluation reports for companies to submit as supplementary application materials.

Development of generic drugs

Generic drug

SkyRun Pharma offers integrated R&D services that span the entire generic drug development process. We provide seamless integration from process development to clinical and commercial-scale drug production, enabling a cohesive service. Our offerings encompass a one-stop solution, including pre-formulation studies, formulation development, quality research, production of clinical trial materials, and drug registration services. This holistic approach assists clients in efficiently progressing from preclinical research to regulatory approval stages.

Specific business content

  • Reference preparation
    Selection of reference formulations
    Filing, review, and one-time import of reference formulations
    Study on Reference Preparation Reverse engineering
  • Preparation research
    Quality of raw materials and packaging materials
    Control prescription process screening and optimization to technology transfer
    Consistency of in vitro quality between self-developed products and reference formulations
    Comparative research, etc
  • Quality research and control
    Stability Study Compatibility Study
  • Clinical trial services
    Review by the Ethics Committee and BE Filing BE Pre Trial/BE Trial

CDMO

  • Small Molecule Synthesis

    Small Molecule Synthesis

    We offer a range of customized synthesis services for small molecules, including active pharmaceutical ingredients, pharmaceutical intermediates, chemical intermediates, and drug impurities, among others.

    Service Include:

    Advanced API Development Services

    Green and Sustainable Chemical Development Services

    Customized, Research, and Manufacturing Services for Advanced APIs and Intermediates

  • Key Technologies

    Key Technologies

    Friedel-Crafts Alkylation, Hydrogenation, Chlorination Reaction, Cyanation Reaction, High-Pressure High-Temperature Reaction

    Chiral Synthesis, Chiral Resolution, Hofmann Reaction.

    Possessing large-scale commercial manufacturing capabilities with over a dozen chemical reactions, extensive production experience in safety and environmental protection

  • R & D

    R & D

    With a portfolio of over 500 products, including antibacterials, anticancer agents, antivirals, and anti-tuberculosis compounds, we leverage our advanced discovery platform to offer candidate synthesis and CMC services and solutions to pharmaceutical and biotechnology companies worldwide.

    We are committed to meeting the global market's demands by providing high-quality products and comprehensive services to our clients. With strong capabilities and a highly skilled team in chemical synthesis, process development, analytical testing, and formulation development, our company holds a significant advantage in new drug development. Particularly, we excel in areas such as antibacterials, antivirals, anti-tuberculosis agents, anticancer drugs, cardiovascular treatments, and antidiabetic compounds. We offer over 400 catalog and custom products, as well as services in generic drug development, technology transfer, and clinical registration. Upholding harmony between our company and the environment, we prioritize eco-friendly and energy-saving technologies, ensuring the highest standards of clean manufacturing and environmental protection.

Small molecule synthesis

We provide customization and synthesis of various small molecules, including active pharmaceutical ingredients, pharmaceutical intermediates, chemical intermediates, and pharmaceutical impurities.

Our scope:

Advanced API development services

Green and environmentally friendly chemical development services

Customization, research and development, and manufacturing services for advanced raw materials and intermediates

key technology

Foucault alkylation, hydrogenation, chlorination, cyanide reaction, high-pressure high-temperature reaction

Chiral synthesis, chiral resolution, Hoffman reaction

Large commercial manufacturing capacity with over ten chemical reactions, with rich production experience in safety and environmental protection

R & D

More than 500 products, including antibacterial, anti-tumor, antiviral, and anti-tuberculosis. With our advanced discovery platform, we are able to provide candidate synthesis and CMC services and solutions for global pharmaceutical and biotechnology companies.

We are committed to meeting the needs of the global market and providing customers with high-quality products and comprehensive services. The company has strong strength and high-level talents in chemical synthesis, processing and development, analysis and detection, and preparation development, and has advantages in developing new drugs, especially in the fields of antibacterial, antiviral, antituberculosis, anti-tumor, cardiovascular, and anti diabetes. We can provide over 400 catalogs and customized products, as well as services such as generic drug development and transfer, clinical registration, etc. Adhering to the harmonious development between the company and the environment, by adopting environmentally friendly and energy-saving technologies, we can maintain the highest level of clean manufacturing and environmental protection.

R&D core platform

  • Small molecule innovative drug discovery platform
  • Research and development platform for sustained and controlled release formulations
  • Industrial platform for optimizing raw material synthesis process
  • Preparation Reverse engineering research platform
  • Element Impurity Research Platform

The small molecule innovative drug discovery platform integrates interdisciplinary knowledge from fields such as bioinformatics, medicine, pharmacy, organic chemistry, and pharmacology. Utilizing advanced computer-aided design techniques and based on research into significant targets for major diseases like cancer and immunity, the platform is engaged in the original design, synthesis, and pharmacology-toxicology research of small molecule drugs. The company focuses on novel key targets in disease development like FGFR/FGFR4, ALK, ATR, HIF-2a, Tyk2, Btk, designing a plethora of compounds and screening out a series of lead compounds. Building upon these leads, ongoing structural optimization leads to the identification of ideal candidate compounds. In the nearly 4 years since the establishment of the company's platform, it has achieved candidate drugs for FGFR4 and ALK targets, applied for compound patents, and is currently conducting preclinical pharmacology and toxicology research. The company is steadily progressing with planned new drug clinical trial applications.

The sustained-release formulation development platform is dedicated to the research, industrialization, and registration of oral sustained-release formulations. The platform has established membrane-controlled, matrix-controlled, and reservoir-controlled sustained-release drug delivery system technologies, including coated sustained-release microsphere technology, extrusion-spheronization-fluid bed coating sustained-release microparticle technology, laser-drilled osmotic pump-controlled release technology, matrix-controlled release technology, solid dispersion technology, and more. Multiple in vitro dissolution testing methods and comprehensive quality standards for oral sustained-release formulations have been established to ensure the durability of formulation processes and high consistency in dissolution.

Over the past 2 years since the platform's establishment, the company has conducted a series of research and development activities for sustained-release formulations. Research and early-stage quality studies have been completed for Metoprolol Succinate Sustained-Release Tablets, Dextromethorphan Sustained-Release Suspension, Sodium Valproate Sustained-Release Tablets, and Rabeprazole Sodium Enteric-Coated Tablets. These projects are currently in the pilot-scale amplification stage, with some projects having completed pre-bioequivalence tests. It is anticipated that they will progressively move into process validation, bioequivalence studies, stability testing, and submission in the coming year.

The platform is composed of the company's R&D department, production department, and external experts, and has formed industry university research cooperation with multiple institutions. The platform conducts research on the synthesis process, process optimization, quality research, industrial production, and registration application of new and generic pharmaceutical raw materials. The platform excels in the synthesis of chiral drugs and the separation and purification of unknown impurities. The platform has completed the industrial production of multiple difficult raw materials and complex injection excipients, completed comprehensive quality research, and plans to submit them for raw material related review and registration.

Formulation Reverse Engineering Research Platform
Reverse engineering research involves the analysis of the reference drug to infer critical indicators such as the content of raw materials and the manufacturing process of the formulation. Most generic drugs consist of active ingredients and excipients. Active ingredients possess pharmacological activity and contribute to the drug's therapeutic effect. Excipients, while lacking direct clinical activity, can impact the quality, safety, and efficacy of the drug to some extent. The study of functional excipients in generic drugs and the physicochemical properties of API (molecular-level research) is a crucial step in reverse engineering and can even play a decisive role in the success of generic drug development.

Elemental Impurity Research Platform
Controlling impurities during drug manufacturing is crucial for drug safety. Research has shown that elemental impurities can contribute to various human cancers and neurological disorders. Therefore, the ICH Q3D guideline establishes quantitative and qualitative limits for various metal impurities in drugs.

Our company conducts methodological research and testing for elemental impurities in pharmaceuticals based on the requirements of ICH and various pharmacopoeias. The research data meet registration application requirements and can support client audits and regulatory inspections. Our team has accumulated extensive experience and is equipped with state-of-the-art instrumentation.

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