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) DMF also available in other selected countries outside EU/US |
||
Packaging sizes |
|
||
Packaging material |
|
||
Shelf life |
| ||
Storage conditions |
| ||
