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 | √ |
