Description
Type of Drugs Manufactured:
Small Molecule
CDMO Services:
Drug Substance Manufacturing (API);Drug Product Formulation (FDF);Aseptic Fill Finish;Research & Development;Clinical Trials materials and logistics;Packaging;Regulatory Services;Analytical Development
No. of Manufacturing Facilities:
More than 10
High Potent Products capabilities:
OEB 3;OEB >5
Facilities Locations:
North America
Regulatory Approvals for facilities:
FDA (United States);EMA (Europe);ISO;GMP;PMDA (Japan);NMPA (China);Health Canada;ANVISA (Brazil)
Manufacturing Technologies:
Blow-Fill-Seal (BFS);Cartridges;Inhalers;
Company Products and Services:
CMO/CDMO
Current Capacity:
CRAMSN Research Park is a state-of-the-art facility designed to support a wide range of chemical and pharmaceutical production activities, from small-scale synthesis to large-scale manufacturing for clinical trials and commercialization. The CRAMSN Research Park has a comprehensive set of reactors, with capabilities ranging from 5L to 100L in scale for synthesis and data generation, as well as larger 5KL reactors for kilo lab-scale production. The facility is capable of synthesizing both cGMP and non-GMP materials for clinical studies (from grams to kilograms), and is equipped for addressing complex pharmaceutical needs, such as stability studies, polymorphism analysis, and solid-state characteristics.
Key features include:
Advanced Chemical Expertise: Specialized in various chemical transformations including asymmetric catalysis, chiral resolutions, halogenations, oxidation, reduction, and enzymatic processes.
Cryogenic & HPAPI Capabilities: The facility can handle extreme temperatures (-90°C to 140°C) and highly potent APIs with strict safety measures.
Specialized Equipment: Including hydrogenation reactors, spray dryers, particle size reduction, and peptide synthesis reactors (SPPS & LPPS). It also features advanced purification tools like ATEX prep HPLC systems and lyophilization units.
Quality and Safety: The facility emphasizes safety with features, HPAPI containment, and a Class 100,000 cleanroom for particle size reduction.For finished dosage forms (FDF), CRAMSN Research Park excels in a wide range of formats:
Oral Liquids: Including syrups, solutions, and suspensions (~7 million).
Parenteral: Injectable formulations, including ampoules, vials, depot injections, and pre-filled syringes (~40 million units).
Contact Information
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