Oral & Topical-Asymchem Labs.

Oral and Topical Formulations

We have comprehensive oral and topical formulation development and manufacturing capabilities, covering full process services from formulation and process development, process scale up and optimization to clinical batches, registration batches and commercial manufacturing. With rich project experience, we can efficiently complete the full process work from preformulation studies to IND filings in about 20 weeks. To date, we have completed over 600 formulation development and clinical manufacturing projects, and successfully passed multiple PAI inspections by NMPA and FDA. Commercial products are continuously and stably supplied to the market, providing reliable end to end solutions for partners.

Support Multiple Dosage Forms From Preformulation To Commercial Manufacturing

Conventional tablets, extended release tablets, enteric coated tablets

Conventional capsules, pellets, granules

Oral solutions or oral suspensions

A variety of topical formulations, including gels, creams and emulsions

Service Capabilities

Formulation R&D

Rapid formulation and process development for solid and topical formulations based on the QbD concept

Solubilization of poorly soluble drugs, such as spray drying and hot melt extrusion

Process risk assessment and establishment of control measures

Process DOE studies, process scale up and process validation

Formulation manufacturing

We have 3 independent cGMP formulation workshops, 1 explosion proof spray drying cGMP workshop and 1 beta lactam formulation workshop, capable of quickly providing manufacturing services from IND to commercial production based on the stage of client projects.

Manufacturing of registration batches and clinical batches

Commercial manufacturing

Evaluation and prediction of stability data

Technology Platforms

Spray drying technology

Hot melt extrusion technology

Nanocrystal Technology

Topical semi solid formulation technology

Oral Peptide Formulation Technology

Wet granulator

Fluidized bed

Mixer

Rotary tablet press

Coater

Roller compactor

Tablet press

Capsule filler & capsule polisher

Bottling line

Oral formulations, vacuum homogenizer

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