Therapeutic Goods Administration (TGA) inspectors who visited the site in June issued it with an A1 rating according to Asymchem, which said the audit was the second the facility has passed since 2015 (here in Mandarin).
Asymchem’s subsidiary Jilin Asymchem Laboratories Co, Ltd operates the Dunhua plant, which makes active pharmaceutical ingredients (API) and intermediates for the domestic and international markets.
The facility houses cGMP compliant pilot and API production capabilities, as well as a capacity for catalytic hydrogenation for the production of drug ingredients and intermediates.
US FDA approval
In September, the Dunhua site passed a preapproval inspection (PAI) by the US Food and Drug Administration (FDA).
Asymchem said a customer’s submission of a new drug application (NDA) that included an intermediate produced at the facility prompted the audit.
According to its website, Asymchem is currently setting up an API and finished dosage form production facility in Tianjin. The firm states that the facility - which will be operated by its subsidiary Tianjin Asymchem Pharmaceuticals Co. Ltd. – will be available in 2017.
Profit forecast
In other news, Asymchem predicted its net profit for the fiscal year 2017 would increase 25% to 35%, to 316m to 341m yuan ($47.5m to $51.3m).
The firm cited “new drug development” as the main driver (here in Mandarin).