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News
Hameln has received certificate “Union Format for Registration of Manufacturer (pdf), Importer or Distribution of Active Substances” which was issued by the Slovak health authority SIDC. Using this certificate Hameln is eligible to trade and sell the following
- EU Market releases
- Photostability Testing according to ICH Q1B
- Stability studies for all dosage forms at various temperature / humidity
| 5°C ± 3°C / – |
| 25°C ± 2°C / 60% ± 5% R.H. |
| 30°C ± 2°C / 65% ± 5% R.H. |
| 30°C ± 2°C / 75% ± 5% R.H. |
| 40°C ± 2°C / 75% ± 5% R.H. |
- Sterile Products (batch certification)
- Non-sterile products (batch certification)
- Manufacture of non-sterile active substance
- Quality Control Testing
- Quality Control Testing
- Sterile Products (batch certification)
- Non-sterile products (batch certification)
- Sterile Products (batch certification)
- Non-sterile products (batch certification)
- Manufacture of non-sterile active substance
- Quality Control Testing
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