Changshan Pharmaceutical
APIs' Production Lines
There is dedicated production workshop respectively for Heparin API, Enoxaparin Sodium API and Dalteparin Sodium&Nadroparin Calcium API. These three workshops are all newly established and have their respective dedicated production equipments, HVAC system and purify water system.
| APIs' Annual Capacity | |||
|---|---|---|---|
| Heparin Sodium API: 5 million mega DMF No.: 24595 | |||
| Enoxaparin Sodium API: 5,000kg DMF No.: 26258 | |||
| Dalteparin Sodium API: 3,000 kg DMF No.: 29154 | |||
| Nadroparin Calcium API: 3,000 kg | |||
| Hyaluronic Sodium API: 21,000 kg |
F5 B+S Syringe Filling Line
German B+S pre-filling syringe filling machine:
Full servo technology, maintenance-free design, and integration with Swiss SKAN aseptic isolator to achieve the highest level of aseptic conditions of automated production, and fully meet the FDA and European GMP standards.
Switzerland SKAN:
Isolator, to isolate the production equipment completely from the workshop environment in order to achieve the best production environment. To isolate the product and worker. Let product be safe, and worker be comfortable.
| Product lines | Capacity /year(Million) | Batch number | Batch production time (h) |
|---|---|---|---|
| F1,Terminal Sterilization-ampoule line | 30 | 250 | ≤ 8 |
| F2, Aseptic -ampoule line | 30 | 250 | ≤ 8 |
| F3, Aseptic -vial line | 25 | 250 | ≤ 8 |
| F4, Aseptic -PFS line | 40 | 250 | ≤ 8 |
| F5, Aseptic -PFS line (constructioning) | 60 | 250 | ≤ 8 |
| FDFs' Annual Capacity | |||
|---|---|---|---|
| Heparin Sodium Injection (vials): 20 million | |||
| Heparin Sodium Injection (ampoul): 80 million | |||
| LMWH Injection (PFS): 40 million |
Construction started on July 2015, located in Zhengding high-tech industrial district, covering an area of around 198,000㎡ , including 66,700㎡ for crude heparin project.
Yearly processing 7,500,000 of procine intestine mucosa，3,000,000 of prepared intestine, and around 500000 mega of crude heparin, and there will be a project II which could help to double the above production quantity.
Crude Base
