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Tyrothricin

Tyrothricin contains about 20% gramicidin and 80% tyrocidine and belongs to the family of polypeptide antibiotics. It is active against a variety of Gram-positive bacteria, including Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus and bacteria causing diphtheria.

Indication: Used in the treatment of local infections; mainly infections of the mouth and throat.

Application: Formulated alone or in combination drug products used in lozenges and topicals.

 

Product grades

Non-sterile

Compliance

Ph. Eur.

USP

Manufacturing site

Xellia Pharmaceuticals Ltd., Budapest, Hungary

Release site

Xellia Pharmaceuticals Ltd., Budapest, Hungary

Site registered

EU GMP issued by Hungarian National Institute of Pharmacy recognised by FDA from March 1st 2018 according to Mutual Recognition Agreement (MRA)

Regulatory documentation

EU Drug Master File (DMF)

Certificate of Suitability (CEP)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

500 g

5 kg

10 kg

Packaging material

Primary: Polyethylene bag closed with twist tie plastic clip

Secondary: Heat sealed multi-layer laminated aluminum bag

Shelf life

5 years

Storage conditions

Below 25°C (77°F)