Xelia Tobramycin Sulfate

Xelia Tobramycin Sulfate is the sulfate salt of tobramycin, an aminoglycoside antibiotic active against Gram-negative bacteria including most Entero-bacteriaceae such as Pseudomonas aeruginosa, and a few Gram-positive bacteria such as Staphylococcus aureus.

Functions: Antibiotic, Disinfectant

Dosage Form: Injectables

Certifications & Compliance: FDA Compliant, GMP, United States Pharmacopeia (USP)

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Identification & Functionality

Pharma & Nutraceuticals Functions

Features & Benefits

Features

Product grades Sterile, non-micronized Non-sterile, non-micronized
Manufacturing site: Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site: Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered: EU GMP issued by Danish Medicines Agency , US FDA, Other health authorities

Applications & Uses

Dosage Form
Applications

Administered systemically by intramuscular injections or intravenous infusions. Can be mixed with bone cement.

Properties

Physical Form

Regulatory & Compliance

Compliance

USP

Regulatory documentation

EU Drug Master File (DMF)
US Drug Master File (DMF)
Letter of Access (LoA)

Packaging & Availability

Packaging sizes

Sterile, non-micronized
2.15 kg
Non-sterile, non-micronized
2.15 kgA*

Packaging material

Sterile, non-micronized
Primary: Aluminum containers with PE insert
and polypropylene lid
Secondary: Polystyrene
Non-sterile, non-micronized
Primary: Aluminum containers with PE insert
Secondary: Polystyrene

Storage & Handling

Shelf-life

3 years

Storage conditions

Below 25°C (77°F)