General:
bela-pharm GmbH & Co. KG possesses a manufacturing permit in accordance with § 13 of the German Medicines Act (AMG) for the commercial production of veterinary medicines. The inspection of this permit generally takes place every two years through the responsible Inspectorate and also comprises the inspection on the maintenance of Good Manufacturing Practise, GMP).
bela-pharm GmbH & Co. KG is authorized to manufacture veterinary medicines in the following product groups:
Sterile products – aseptically manufactured or sterilised in a final container - in liquid dosage form or as solid substances and implants.
Non-sterile products – liquid dosage forms for external application, liquid dosage forms for internal application and other solid and semi-solid pharmaceutical forms and pharmaceutical premixtures with special requirements.
Other products – homoeopathic pharmaceuticals and active ingredients with microbial origins.
The product forms listed are processed into veterinary medicines. To do this, the different active ingredient classes are processed, taking into consideration the regulations for occupational safety and environmental protection:
Antibiotics, chemotherapeutic agents, local anaesthetics, analgesics, hormones, vitamins, homoeopathic products, mineral substances and electrolytes.
The modern production plants, production procedures and inspection mechanisms used guarantee maintenance of the required quality standards:
- Filling using microprocessor-controlled systems
- Automated bottle-stopping, crimping, nesting and final packaging
- Final sterilisation of sterile products in water-sprinkling autoclaves
The following packaging sizes can be produced:
- Injection substances – 1 ml to 250 ml
- Infusion solutions – 250 ml to 10 l
- Oral solutions – 10 ml to 10 l
- Pharmaceutical premixtures (sterile) powder – 1 g to 25 kg