Solutions
Oral Solid Dosage Form

Strong Research & Development Capability

More than 92% of R&D team have a master’s degree or above with a very good education background and formulation development theory. The team has a very good formulation and process development experience and they can develop the product to clinical stages or commercialization quickly via scientific experimental design.


● Dosage form

Conventional tablet, cosmetic coated tablet, sustained release tablet, enteric coated tablet, capsule, granule, pellet.


● Technical platform

Nano-milling; bi-layer or multi-layer tablet; sustained release or controlled release coating; pellet drug loading or coating; solubilization for insoluble API; formulation platform for API with different BCS classification; DoE and process validation


● Project experience

Quality by Design (QbD) based formulation and process development of tablet, capsule and granule; evaluation and prediction of stability data; process design, scale-up, optimization and validation; process risk assessment and control.


6372196217618796524103136[1].jpg


cGMP production

Currently Asymchem has 3 independent cGMP oral solid dosage form facilities, which can quickly provide production services for different projects from IND to commercialization to meet the client’s needs at different stages.


Production capacity

● Dry granulation

● Wet granulation

● Spray drying

● Compression

● Film coating and enteric coating

● Encapsulation

● Sachet package of granule

● Bottle and blister package of tablet and capsule

● Secondary packaging and labelling 

● Can handle low OEL compound


Facility

A variety of state-of-art equipment and over 5,000m2 of validated cGMP facility have been well validated for pilot and commercial-scale production.


Service scope

QbD based formulation and process development; solubilization of insoluble drug, such as solid dispersions via spray drying; registration batch and clinical batch manufacturing; process Design of Experiment (DoEs) and process validation; commercial product manufacturing.


image.png

image.png


Postal Address
  • Asymchem Inc. 600 Airport Blvd PO Box 1310
  • Morrisville NC 27560 USA
Physical Address
  • Asymchem Inc.
  • 600 Airport Blvd., Suite 1000 Morrisville, NC 27560 USA
Contact Us
  • information@asymchem.com
  •  

Group official WeChat

Human resources WeChat