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Gramicidin

Gramicidin is a mixture of linear polypeptides active against a variety of Gram-positive bacteria.

Indication: Ophthalmic solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria, such as conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

 

Application Formulated alone or in combination drug products used in ophthalmic solutions.

 

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

US FDA

Regulatory documentation

EU Drug Master File (DMF)

Certificate of Suitability (CEP)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

100 g

500 g

Packaging material

Primary: Polyethylene bag closed with twist tie plastic clip

Secondary: Heat sealed multi-layer laminated aluminum bag

Shelf life

3 years

Storage conditions

Below 25°C (77°F)