Phone: +49 (0) 30 414-0000 | Email: sales@kbi-berlin.com
KBI is specialized in the field of producing, filling and packaging pharmaceutical and food supplements since the year 1989.
At our location Berlin KBI is equipped with the utmost modern machinery and a high level of automation in order to fulfill the most demanding needs of our clients. Our company holds a manufacturing license for non-sterile solid dosage forms and is certified by the local authorities according to the principles and guidelines of Good Manufacturing Practice (GMP). Manufacturing takes place in climatic controlled areas.
KBI offers a production capacity of more than 2500 tons annually.
Up to ten raw material either in powder or as granulates form with particle sizes from 10 up to 1000microns are carefully mixed in a countercurrent mixing unit.
If requested do we manage the complete range starting with the purchasing of raw materials.Besides the below mentioned products we would be very pleased to mix, fill and pack your individual products.
We pack and fill the products on two absolutely state of the art vertical flat bag machines with flexible screw dosage systems three side sealed pouches with perforation and rippled sealing edges. The grammage of the pouches ranges from 5g to up to 40g.
Filling and packaging on high speed machines in pouches (primary) and cardboxes (secondary) is completely automated ensuring top quality.
All packaging materials such as films, prints, cartons etc. do follow precisely your individual specification. We can work with any heat-sealable film types.KBI’s production area like mixing, filling and packaging is GMP certified for non-sterile solid dosage forms. Our production, with a capacity exceeding 2500 tons is equipped with clean-room technology and set under overpressure against outside conditions.
Our internal lab performs the analytics of incoming materials by HPLC as well as in-process control of the mixing process and the final release analysis of the finished goods. Raw materials are analyzed following relevant monograph and dossier.
Any further analysis such as GCMS, AAS and microbiological tests as well as stability tests are conducted at certified partner labs. These labs have installed a Quality Management System following § 3 AMWHV and are authorized to conduct product analysis following §14 Item 4 Nr.3 German Medicines Law (AMG) or they are an approved organization to examine drugs and pharmaceutical products as a contract lab following § 14 Item. 4 and § 67 German Medicines Law (AMG).
Oral Rehydration Salt 20,5g Low Osmolarity according to British Pharmacopoeia:
| Composition | Specification | Mass |
| Glucose anhydruos | Ph. Eur. | 13,5g |
| Sodium chloride | Ph. Eur. | 2,6g |
| Sodium citrate | Ph. Eur. | 2,9g |
| Potassium chloride | Ph. Eur. | 1,5g |
| Ready for use dilution in 1000 ml water | ||
Oral Rehydration Salt 27,9g – old formulation:
| Composition | Specification | Mass |
| Glucose anhydruos | Ph. Eur. | 20,0g |
| Sodium chloride | Ph. Eur. | 3,5g |
| Sodium citrate | Ph. Eur. | 2,9g |
| Potassium chloride | Ph. Eur. | 1,5g |
| Ready for use dilution in 1000 ml water | ||
Oral Rehydration Salt Orange flavour - Low Osmolarity according to British Pharmacopoeia:
| Composition | Specification | Mass |
| Glucose anhydruos | Ph. Eur. | 13,5g |
| Sodium chloride | Ph. Eur. | 2,6g |
| Sodium citrate | Ph. Eur. | 2,9g |
| Potassium chloride | Ph. Eur. | 1,5g |
| Excipient | g.s. | |
| Ready for use dilution in 1000 ml water | ||
KBI Pharmaceuticals GmbH & Co. KG
Eichborndamm 141 -165
13403 Berlin
Phone: +49 (0)30 414-0000
Fax: +49 (0)30 414-00099
Email:
sales@kbi-berlin.com
Address & contact information see left
Amtsgericht Charlottenburg HRA 21633
Persönlich haftende Gesellschafterin:
KBI Pharmaceuticals – Verwaltungs-GmbH
Amtsgericht Charlottenburg HRB 28113
Geschäftsführer: Matthias Minderjahn