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API products

Precision at the source: reliable API manufacturing for critical anti-infectives

Amphotericin B

Amphotericin B is a mixture of polyenes active against a wide variety of fungi e.g. Aspergillus, Candida and Cryptococcus species.

Indication: Used in the treatment of severe, invasive, potentially life-threatening fungal infections (mycosis) typically in immunocompromised patients.

Applications: Administered intravenously as a colloidal complex with sodium deoxycholate or as a liposomal formulation. The low germ and endotoxin content makes Xellia’s amphotericin B particularly suitable for parenteral use.

Bacitracin

Bacitracin is composed of a group of polypeptides with antibiotic activity against a variety of gram-positive bacteria including staphylococci.

Indication: Used locally for the treatment of infections of the skin, ear, and eye or for intramuscular use in infants for the treatment of pneumonia and empyema caused by susceptible staphylococci in some parts of the world (e.g. Canada).

Application: Administered locally as a combination drug product used in powders, ointments, and solutions. Bacitracin is also administered systemically as intramuscular injections in some parts of the world (e.g. Canada).

Bacitracin zinc

Bacitracin zinc is composed of a group of polypeptides with antibiotic activity against a variety of gram-positive bacteria including staphylococci. The zinc complex adds stability to the component, making bacitracin zinc more stable compared to bacitracin.

Indication: Used in the treatment of local infections, mainly infections of the skin, ear, and eye.

Application: Administered locally as a combination drug product used in powders, ointments, and solutions.

Colistimethate sodium

Colistimethate sodium is a prodrug of colistin (polymyxin E) which is a mixture of polypeptide antibiotics active against gram-negative bacteria, including Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.


Indication: Used in the treatment of acute or chronic infections due to sensitive strains of gram-negative pathogens, especially in patients with limited treatment options.


Application: Administered systemically as intramuscular injections and intravenous injections or infusions. Colistimethate sodium can also be administered intrathecally, by intraventricular administration, by inhalation or mixed with bone cement.

Daptomycin - Budapest

Daptomycin is a lipopeptide antibiotic active against gram-positive bacteria such as Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis and Enterococcus faecalis (vancomycin-susceptible isolates only).


Indication: Used in the treatment of complicated skin and skin structure/soft-tissue infections caused by susceptible isolates of gram-positive bacteria in adult and pediatric patients and in the treatment of patients with Staphylococcus aureus (including MRSA-methicillin-resistant strains) bacteremia, as well as right-sided endocarditis.


Application: Administered systemically as intravenous infusion or injection.

Daptomycin - CMO

Daptomycin is a lipopeptide antibiotic active against gram-positive bacteria such as Staphylococcus aureus (including methicillin resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).


Indication: Used in the treatment of complicated skin and skin structure/soft-tissue infections caused by susceptible isolates of gram-positive bacteria in adult and pediatric patients and in the treatment of patients with Staphylococcus aureus (including MRSA-methicillin-resistant strains) bacteremia, as well as right-sided endocarditis in adults.


Application: Administered systemically as intravenous infusion or injection.

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.

Polymyxin B sulfate

Polymyxin B sulfate is a mixture of sulfates of polypeptide antibiotics active against Pseudomonas aeruginosa and other gram-negative bacteria except the Proteus group.


Indication: Used in the treatment of acute urinary, meningeal, or blood stream infections due to Pseudomonas aeruginosa and other gram-negative pathogens causing serious infections when less potentially toxic drugs are ineffective or contraindicated. It is often used as a combination drug product for the local treatment of skin, ear, eye, and vaginal infections.


Application: Administered systemically as intravenous infusions, intramuscular or intrathecal injections, and locally as eye drops, ear drops, intravaginal capsules, or subconjunctival injections.

Tobramycin sulfate

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


Indication: Used in the treatment of septicemia (bloodstream infection), infections of the skin, bone, lower respiratory tract, central nervous system, intra-abdominal and complicated recurrent urinary tract infections.


Application: Administered systemically by intramuscular injections or intravenous infusions, locally as ophthalmic solution, conjunctival ointment, or by inhalation. Can be mixed with bone cement.

Tyrothricin

Tyrothricin contains about 20% gramicidin and 80% tyrocidine and belongs to the family of polypeptide antibiotics. It is active against a variety of gram-positive bacteria, including Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, and bacteria causing diphtheria.

Indication: Used in the treatment of local infections; mainly infections of the mouth, throat, and superficial skin wounds.


Application: Formulated alone or as a combination drug product used in lozenges and topicals.

Vancomycin hydrochloride - Budapest

Vancomycin hydrochloride is a glycopeptide antibiotic active against a wide variety of gram-positive bacteria, most important being staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains), but also active against diphtheroids, enterococci (e.g., Enterococcus faecalis), Streptococcus bovis and viridans group streptococci.


Indication: Used in the treatment of lower respiratory tract infections, septicemia, bone, skin, and skin structure infections, and infective endocarditis due to severe systemic methicillin resistant (MRSA) and sensitive strains where other antibiotics cannot be used because of intolerance or drug resistance. May be administered orally for treating antibiotic-associated pseudomembranous colitis produced by Clostridium difficile and for staphylococcal enterocolitis.


Application: Administered systemically as intravenous infusions and as capsules for oral administration. IV form can also be used orally for the treatment of antibiotic-associated pseudomembranous colitis and staphylococcal enterocolitis.

Vancomycin hydrochloride - Copenhagen

Vancomycin hydrochloride is a glycopeptide antibiotic active against a wide variety of gram-positive bacteria, most important being staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains), but also active against diphtheroids, enterococci (e.g. Enterococcus faecalis), Streptococcus bovis, and viridans group streptococci.

Indication: Used in the treatment of lower respiratory tract infections, septicemia, bone, skin, and skin structure infections, and infective endocarditis due to severe systemic methicillin resistant (MRSA) and sensitive strains where other antibiotics cannot be used because of intolerance or drug resistance. May be administered orally for treating antibiotic-associated pseudomembranous colitis produced by Clostridium difficile and for staphylococcal enterocolitis.

Application: Administered systemically as intravenous infusions and as capsules for oral administration. IV form can also be used orally for the treatment of antibiotic-associated pseudomembranous colitis and staphylococcal enterocolitis.

Vancomycin hydrochloride - Taizhou

Vancomycin hydrochloride is a glycopeptide antibiotic active against a wide variety of gram-positive bacteria, most important being staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains), but also active against diphtheroids, enterococci (e.g, Enterococcus faecalis), Streptococcus bovis, and viridans group streptococci.

Indication: Used in the treatment of lower respiratory tract infections, septicemia, bone, skin, and skin structure infections, and infective endocarditis due to severe systemic methicillin resistant (MRSA) and sensitive strains where other antibiotics cannot be used because of intolerance or drug resistance. May be administered orally for treating antibiotic-associated pseudomembranous colitis produced by Clostridium difficile and for staphylococcal enterocolitis.

Application: Administered systemically as intravenous infusions and as capsules for oral administration. IV form can also be used orally for the treatment of antibiotic-associated pseudomembranous colitis and staphylococcal enterocolitis.