Rocky pharm Chemical Raw Materials CDMO Solution
Welcome to explore Rocky Pharm CDMO services! We cover the full chain of pharmaceuticals, cosmetics, and nutraceuticals, Our capabilities span preclinical R&D, process scale-up, GMP production, and final packaging. With custom-tailored services, we help clients of all sizes optimize cost, speed, and product quality. Whether you need support for APIs, cosmetic ingredients, or food supplements, our technical team ensures precision at every step.
Product Center
Product Advantages
Comprehensive CDMO Services: From Process Development to Commercial Production
Customized Process Development
Enzyme Engineering:
Through directed evolution, improving enzyme thermal stability (up to 50°C) and substrate tolerance to meet cost-effective methods for paclitaxel side chain production.
Impurity Control:
Utilizing online PAT (Process Analytical Technology) to monitor by-products (e.g., enantiomers) in real time, ensuring increased purity of paclitaxel intermediates using enzymes.
Quality and Regulatory Compliance
Analytical Method Development:
Integrating chiral HPLC (Chiralpak AD-H column) with polarimetry to accurately detect the optical purity of paclitaxel side chains.
Global Regulatory Support:
Providing FDA/EMA-compliant CMC documentation, including enzyme source toxicology data, process validation reports, and comparative studies on the advantages of enzymatic resolution in paclitaxel intermediate production.
Technical Specifications
Rocky Pharm has established long-term cooperation with China's top analysis&testing centers, institutes and universities, which are equipped with various facilities for special chemical reactions and testing conditions, including HPLC, LC-MS, GC, GCMS, UV, etc., to provide you various testing services for products throughout the entire product development cycle.
Additionally, Rocky Pharm cooperates closely with Chinese factories, which have advanced production equipments and experts with rich experience in organic chemistry, enzyme catalysis, fermentation processes, etc. They strictly comply with both Chinese and international GMP regulation and ICH Q7 quality management specification.
Compounds
(1) Chiral compounds
(2) Prostaglandin series products
(3) peptide synthesis
(4) One-step microbial enzymes synthesis method
(5) Separation and purification of fermentation products（Antibiotics）
(6) Create a new synthetic route which is different from patent route(avoid patent)
(7) Plant extracts with high quality(99% up) and special specifications (Purification & Separation)
(8) Custom developing and manufacturing of pharmaceutical intermediates or colorant intermediates（including Amino-, Nitro-, Hydroxyl -, Borono-, etc.） by Continuous Flow Technology. (pharmaceutical/dye intermediates)
(9) Protected Amino Acid
(10) ADC Linker
Reactions
(1) Grignard reaction
(2) Oxidation / Reduction
(3) Ring closure reaction
(4) Condensation reaction
(5) Halogenation
(6) Nitration
(7) Amination
(8) Enzyme catalysis/catalyzed reaction
(9) Enzymatic resolution
(10)Continuous flow reaction
Special facilities that can meet these circumstances:
(1) High vacuum (reach 1mmHg)
(2) Low temperature (reach -100℃)
(3)High temperature(reach 200℃)
Available sites/lines
(1)cGMP manufacturing site for custom manufacturing
(2)High active API(to OEB5) production line (20L-100L)
(3)HSCCC（High Speed Countercurrent Chromatography）Technique
(4)Continuous Flow Technology（pipeline）
Application
CDMO For API And Pharmaceutical Intermediate
Enzymatic Resolution of Paclitaxel Side Chain: CDMO-Driven Green and Efficient Production of Anticancer Drugs
Paclitaxel, as a key broad-spectrum anticancer drug, relies heavily on the chiral purity of its side chain for therapeutic efficacy and safety. Traditional chemical resolution methods are costly and environmentally burdensome, while enzymatic resolution of chiral intermediates offers a greener and more efficient alternative. This method has become a strategic choice for global CDMO (Contract Development and Manufacturing Organization) companies aiming to optimize the production of paclitaxel intermediates.
CDMO For Food Supplement
Red Yeast Rice CDMO Process — Empowering Natural Cholesterol-Lowering Ingredients with Technology
Natural Red Yeast Rice, as a source of the naturally occurring statin compound Monacolin K, is recognized for its efficacy in cholesterol regulation (Red Yeast Rice cholesterol) and has become a star ingredient in the cardiovascular health sector. As a leading CDMO provider in pharmaceuticals and nutraceuticals, we offer end-to-end solutions for Red Yeast Rice supplements by leveraging high-purity fermentation technology and innovative compounding techniques.
CDMO For Cosmetic Raw Materials
Chromatographic Purification of Bakuchiol: CDMO Empowering High-Purity Anti-Aging Ingredient Production
Bakuchiol, recognized as a natural alternative to retinol, has its efficacy closely tied to its purity and color. Traditional extraction methods often leave residual reddish pigments and fail to achieve high purity. Utilizing commercial chromatography for bakuchiol, precise separation techniques can yield high-purity bakuchiol (99%+) while addressing the color challenge. This advancement provides the cosmetic and pharmaceutical industries with premium-grade ingredients.
CDMO For Fine Chemicals
Continuous Flow Reaction Technology – The Innovation Engine for Pesticide and Dye Intermediate CDMO Processes
Continuous flow reaction technology, with its core advantages of efficiency, safety, and sustainability, is reshaping the production model for pesticide and dye intermediates. As a leading CDMO in the pharmaceutical and chemical sectors, we apply this technology in Continuous flow synthesis of pesticides and Continuous flow dye intermediate production, providing global customers with high-purity, low-cost, customized solutions.
CDMO For Peptide And Amino Derivatives
Peptide/Amino Acid Derivative CDMO Process - Customization Empowering the Development of Innovative Therapies
The efficacy and stability of peptide drugs (such as semaglutide and tirzepatide) are highly dependent on precise synthesis of side chain modifications and protected amino acids. As a global leading CDMO enterprise in the pharmaceutical industry, we provide efficient and compliant process solutions for GLP-1 receptor agonists, diabetes drugs, and more through Custom peptide synthesis and Amino acid derivative customization technologies.
Contact Us
Whether you’re seeking details on our CDMO services for cosmetic raw materials, APIs, food supplements, or fine chemicals, need tailored solutions for your project, or want to confirm compliance standards (e.g., FDA, GMP, Halal), we’re here to help. Reach out to our team, and we’ll provide professional, timely support to advance your needs.
FAQs
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Keep In Touch With Us
Our professional team will provide you with detailed product information, answer your questions, and tailor the best solution to meet your needs.
E-mail：info@rockypharm.hk
