Xelia Gramicidin

Xelia Gramicidin is a mixture of linear polypeptides active against a variety of Gram-positive bacteria. Application Formulated alone or in combination drug products used in ophthalmic solutions.

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, United States Pharmacopeia (USP)

Dosage Form: Creams

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Identification & Functionality

Chemical Family
Pharma & Nutraceuticals Functions

Features & Benefits

Features

Product grades:  Non-sterile
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

Applications & Uses

Dosage Form
Applications

Formulated alone or in combination drug products used in ophthalmic solutions and as a topical antibiotic for the
treatment of skin infections

Properties

Physical Form

Regulatory & Compliance

Compliance

Ph. Eur.
USP

Regulatory documentation

EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
Letter of Access (LoA)

Packaging & Availability

Packaging Type
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

Storage & Handling

Shelf-life

3 years

Storage conditions

Below 25°C (77°F)