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Vancomycin HCl capsules

Vancomycin hydrochloride is a glycopeptide antibiotic active against a wide variety of Gram-positive bacteria.

Indication: Used in the treatment of patients with Clostridium difficile infection (CDI).

Application: Administered orally.

Dosage form

Hard gelatine capsules

Strength

125 mg

250 mg

Compliance

Currently there is no monograph for vancomycin hydrochloride capsules in Ph.Eur.

USP

Manufacturing site

CMO for Xellia Pharmaceuticals ApS

Release site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Site registered

EU GMP issued by Medicines and Healthcare products Regulatory Agency

US FDA

Other Health Authorities

Batch size

125 mg

250mg

200 000 capsules

100 000 capsules

Regulatory documentation

EU dossier

Packaging material

125 mg capsules

250 mg capsules

20 capsules/pack

28 capsules/pack

20 capsules/pack

28 capsules/pack

Shelf life

24 months

Storage conditions

Between 20-25°C (68-77°F)