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 |
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Manufacturing site |
Xellia Pharmaceuticals Ltd., Budapest, Hungary |
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Release site |
Xellia Pharmaceuticals Ltd., Budapest, Hungary |
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Site registered |
EU GMP issued by Hungarian National Institute of Pharmacy US FDA |
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Regulatory documentation |
EU Drug Master File (DMF) Certificate of Suitability (CEP) US Drug Master File (DMF) Letter of Access (LoA) |
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