Quality System
Quality System
CGMP Compliance
All facilities for APIs and different dosage forms (peptide APIs, oral solid dosages, sterile injections and lyophilized formulations) comply with cGMP requirements.
We are always keeping update for our quality system. Since 2013, Hainan headquarter has passed several inspections by foreign Authorities, including US FDA unannounced inspection, PAI and EMA on-site inspection; and in last quarter of 2019, Ningbo site was also inspected by US FDA and received the approval letter.
Independent Quality Units

International GMP inspections

No. Inspection Inspected by Time Product Complied
or not
1 GMP Inspection US FDA Aug. 2013 Eptifibatide intermediate
2 Unannounced inspection US FDA Jan. 2016 Eptifibatide intermediate
3 GMP Inspection AIFA (Italian) Sept. 2016 Thymalfasin API & FDF
4 PAI US FDA May 2017 Bivalirudin API & FDF
5 Unannounced  Inspection US FDA Apr. 2019 /
6 PAI US FDA Oct. 2019 Memantine Hydrochloride Tablets