Our facilities comply with the highest quality standards, having passed inspections by authorities from the US, EU, and Japan.

Inspection History

Quality Policy

SLC takes "Respect lives. Under a complete and validated quality system, produce and provide APls and injectable drug product with consistent quality which complies with the quality specifications of developed countries" as the primary guideline for quality.

Our quality systems were established with pharmaceutical good manufacturing practices (GMP) under the following regulations and laws in mind:

  • Current EU guidelines GMP part I and Annexes.
  • Current US GMP 21 CFR Parts 11, 210, 211 & 820
  • Current Taiwan GMP guidelines: PIC/S guidance for GMP.
We have since been qualified by the aforementioned regulatory authorities for cGMP compliance. In addition we have also been qualified by numerous other regulatory authorities:
 
Meropenem and Sodium Carbonate(Sterile Bulk) Imipenem and Cilastatin Sodium(Sterile Bulk) Carbapenem Finished Dosage Form
 
 
 
 
2014

US FDA

Taiwan FDA

US FDA

BR ANVISA

US FDA
2013

Taiwan FDA

UK MHRA

Taiwan FDA

UK MHRA

Taiwan FDA
2012  

Taiwan FDA

Taiwan FDA

Spain AEMPS
2011

Taiwan FDA

UK MHRA

US FDA

Taiwan FDA

UK MHRA

US FDA
 
2010

FR Afssaps

Korea FDA

Korea FDA

UK MHRA
 
2009-2006

Japan PMDA

Taiwan FDA

Taiwan FDA
 

* Pending GMP certification