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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. Medicinal lozenges and spray are indicated for throat inflammatory infections. The topical cream can be used to treat certain skin infections and to prevent infections in burns, skin grafts, minor cuts and wounds. Otic solution can be used to treat infection or inflammation of the ear.

Application: Formulated alone or as a combination drug product used in otic, ophthalmic solutions, medicinal lozenges and spray for sore throat and as a topical antibiotic for the treatment of skin infections.

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 recognized 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)

China Drug Master File (CDMF)

DMF also available in other selected countries outside EU/US

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

Do not store above 25 °C (77 °F)