2016 Passed USFDA unannounced GMP inspection; Passed EMA on-site inspection for sterile drug product Thymalfasin FDA & API;
2017 Received Italian MA decree for Thymalfasin for Injecion; Passed the USFDA PAI for Bivalirudin API & FDF;
2018 Received USFDA tentative approval for Bivalirudin for Injection; Submitted quality consistency evaluation of Thymalfasin for Injection to NMPA;
2019 US FDA unannounced GMP inspection; Successfully challenged the patent of RLD of Bivalirudin for Injection and received US FDA final approval; Received US FDA approval for Pregabalin Capsule; Passed the US FDA PAI for memantine Hydrochloride Tablets
2020 Received US FDA MA approval for Memantine Hydrochloride Tablets; Exported Bivalirudin for Injection to US