• 乐发lll-追求健康,你我一起成长

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    Solution & Service
    Clinical and Commercial Drug Product Manufacturing Services

    Our non-parenteral product manufacturing facilities designed for supporting early clinical trials adhere to global GMP compliance and standards. The total area of these GMP-compliant manufacturing suites is approximately 1000 m2. Each suite is equipped with specific functions to meet the manufacturing requirements of various non-parenteral dosage forms, such as tablets, capsules, particulates, suspensions, creams, and more. This ensures the timely and high-quality delivery of clinical products, as well as the development of commercial formulations and manufacturing processes, technology transfer, process characterization, definition of process control strategies, process performance qualification, and commercial manufacturing. Additionally, Langhua has established strategic collaborations with external pharmaceutical companies to fulfill clients' clinical Phase III and commercial formulation requirements. 

    The main services include followings; they can be either a single unit operation service or combination thereof.

    Micronization——Air-assisted milling (5g/hr to 20kg/hr) or mechanical milling (10g-10kg/hr)

    Blending——Tumbling (0.2L to 100L) or high shear mixing (1L to 120L)

    Granulating——High shear wet (1L to 120L), dry (5g/hr to 40kg/hr), and fluid bed granulation (2L to100 L)

    Drying——Fluid bed (2L to 100L) or Oven drying

    Milling——Comil U5 （50g/hr to 1kg/hr) and ZLJ-125 (up to 150kg/hr)

    Compressing——Fully instrumented single (single station) and bilayer rotary tablet presses (6 and 8 stations, B and D tooling options)

    Encapsulating——Fully instrumented encapsulators (5,000 to 40,000caps/hr）, capable of encapsulating particulates, powder, and liquid

    Coating——Fully instrumented coaters (0.5L to 70L)

    Packaging——Bottle and blister packaging

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