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API & Intermediates CDMO Service

Process Development Service

Synthesis Route Design

Development & Optimization

QbD Study

Process Validation

Manufacturing Service

Process Development Service
Drug Product CDMO Service

Pre-clinical Drug Product R&D Service

Salt and Polymorph Screening

NCE Characterization

Pre Clinical Formulation Development

Clinical Drug Product R&D Services

Clinical and Commercial Drug Product Manufacturing Services

Global Regulatory Submission Services
Analytical Service

API Analysis Service

Pre-formulation Analysis Service

Drug Product Analysis Service

Stability Study

Data Integrity
Support

Global CMC Filing

Project Management

Product Lifecycle Management

For more information about

"Clinical and Commercial Drug Product Manufacturing Services",

please contact our team.

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