Amikacin Inj.Sol 500mg/2ml (EU CTD Available) & 1g/4ml (EU CTD Available: Q3 2021)

Product Description

Amikacin Solution for Injection 
Reference Product: Briklin® / BRISTOL-MYERS SQUIBB
Description: Amikacin sulfate is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella species, Enterobacter species, Serratia species, and Acinetobacter species. 
Dossier Status: EU CTD Available (500mg/2ml) & Q3 2021 (1g/4ml)
Stability Studies: Zone II / Zone IVb
Shelf life: Two (2) years
Batch Size: 18,180 vials (500mg/2ml) & 9,090 vials (1g/4ml)
Pack Size: BT x 1 vial

ANFARM HELLAS S.A.

  • GR
  • 2015
    On CPHI since
Specifications
  • Selling Points
    International Approvals/Standards
  • Supplied from
    Greece

ANFARM HELLAS S.A.

  • GR
  • 2015
    On CPHI since

More Products from ANFARM HELLAS S.A. (36)

  • Sugammadex Inj.Sol. 100mg/ml (2 & 5 ml Vial) (EU CTD Available)

    Product Sugammadex Inj.Sol. 100mg/ml (2 & 5 ml Vial) (EU CTD Available)

    Sugammadex 100mg/ml (2 & 5 ml Vial) Solution for Injection
    Reference Product: Bridion® / MSD
    Description: Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent. 
    It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma ...
  • Tenoxicam Ps.Inj.Sol 20mg/Vial (EU CTD Available)

    Product Tenoxicam Ps.Inj.Sol 20mg/Vial (EU CTD Available)

    Tenoxicam 20 mg/Vial Powder for Solution for Injection Reference Product: Tilcitin® / Meda 
    Description:  Tenoxicam is used in patients considered unable to take oral tenoxicam for the relief of pain and inflammation in osteoarthritis and rheumatoid arthritis and for the short-term manage...
  • Tigecycline Pd.Sol.Inf 50mg/Vial (EU CTD Available)

    Product Tigecycline Pd.Sol.Inf 50mg/Vial (EU CTD Available)

    Tigecycline 50 mg/Vial Powder for Solution for Infusion Reference Product: Tygacil® / Pfizer
    Description: Tigecycline, a glycylcycline antibiotic, inhibits protein translation in bacteria by binding to the 30S ribosomal subunitand blocking entry of amino-acyl tRNA molecules into the A site of the...
  • Vancomycin Pd.Sol.Inf 500mg/Vial (EU CTD Available) & 1g/vial (EU CT Available: Q3 2021)

    Product Vancomycin Pd.Sol.Inf 500mg/Vial (EU CTD Available) & 1g/vial (EU CT Available: Q3 2021)

    Vancomycin Vial Powder for Solution for Infusion
    Reference Product: Voncon® / Lilly
    Description: Vancomycin Hydrochloride is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of Septicemia, Infective Endocarditis, Ski...
  • Vildagliptin & Metformin Tabs (50+850 mg), (50+1000 mg) (EU CTD Available: Q3 2021)

    Product Vildagliptin & Metformin Tabs (50+850 mg), (50+1000 mg) (EU CTD Available: Q3 2021)

    Vildagliptin & Metformin(50+850 mg), (50+1000 mg) Film Coated Tablets Reference Product: Eucreas® / Novartis 
    Description: Vildagliptin & Metformin is a combination of 2 anti-diabetic agents indicated in the treatment of type 2 diabetes mellitus. More specifically, it is indicated...
  • Voriconazole Pd.Sol.Inf 200mg/Vial (EU CTD Available)

    Product Voriconazole Pd.Sol.Inf 200mg/Vial (EU CTD Available)

    Voriconazole 200 mg/Vial Powder for Solution for Infusion
    Reference Product: Vfend® / Pfizer
    Description: In the treatment of the following fungal infections: Invasive aspergillosis, Candidemia, Esophageal candidiasis, Serious fungal infections caused ...
  • Apixaban F.C. Tabs 2.5mg/tab & 5mg/tab  (under development)

    Product Apixaban F.C. Tabs 2.5mg/tab & 5mg/tab (under development)

    Apixaban Film Coated Tablets 2.5mg & 5mg
    Reference Product: Eliquis® / Bristol-Myers Squibb/Pfizer
    Description: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transie...
  • Azithromycin Pd.Sol.Inf 500mg/Vial (EU CTD Available)

    Product Azithromycin Pd.Sol.Inf 500mg/Vial (EU CTD Available)

    Azithromycin 500mg/Vial Powder for Solution for Infusion Reference Product: Zithromax® / PFIZER 
    Description: Azithromycin as powder for solution for infusion is indicated for the treatment of community-acquired pneumonia due to susceptible microorganisms in adult patients where initial intrav...
  • Brivaracetam Oral Solution 10mg/ml (EU CTD Available: Q4 2022)

    Product Brivaracetam Oral Solution 10mg/ml (EU CTD Available: Q4 2022)

    Brivaracetam 10mg/ml Oral Solution
    Reference Product: Briviact® / UCB
    Description: Brivaracetam is an antiepileptic agent which is indicated as adjunctive therapy in the treatment of partial onsetseizures with or without secondary generalization in adults, adolescents and children from 4 year...
  • Brivaracetam Sol. Inf 10mg/ml (5ml Vial) (EU CTD Available: Q3 2022)

    Product Brivaracetam Sol. Inf 10mg/ml (5ml Vial) (EU CTD Available: Q3 2022)

    Brivaracetam 10mg/ml (5ml Vial) Solution for Injection/Infusion
    Reference Product: Briviact® / UCB
    Description: Brivaracetam is an antiepileptic agent which is indicated as adjunctive therapy in the treatment of partial onsetseizures with or without secondary generalization in adults, adolescents and...
  • Butamirate Syr 7.5mg/5ml (200ml Bottle) (EU CTD Available)

    Product Butamirate Syr 7.5mg/5ml (200ml Bottle) (EU CTD Available)

    Butamirate Syrup 7.5mg/5ml (200ml Bottle)  
    Reference Product: Sinecod ®/ NovartisDescription: Butamiratе Syrup is used for the symptomatic treatment of non-productive (dry) cough.
    Dossier Status: EU CTD Available
    Stability Studies: Zone II / Zone I...
  • Caspofungin Pd.C.So.In 50mg/Vial & 70mg/Vial (EU CTD Available)

    Product Caspofungin Pd.C.So.In 50mg/Vial & 70mg/Vial (EU CTD Available)

    Caspofungin 50 & 70 mg/Vial Powder for Concentrate for Solution for Infusion
    Reference Product: Cancidas® / MSD
    Description: Antifungal, used for the treatment of invasive candidiasis in adult or pediatric patients, invasive aspergillosis in adultor pediatric patients who are refractory to or int...

ANFARM HELLAS S.A. resources (27)

Frequently Viewed Together

  • Product Spasmopharm 500 mg/ml + 2 mg/ml + 0,02 mg/ml solution for injection

    For short-term symptomatic treatment of pain of moderate intensity and severe spasm of smooth muscles of internal organs:∙ stomach and intestinal cramps;∙ renal colic with nephrolithiasis;∙ spastic dyskinesia of the biliary tract;∙ algomenorrhea.Active substance(s):Metamizole sodium – 500 mg/ml; Pitofenone...
  • Product Datwyler's solutions for Prefilled Syringe applications

    We offer our customers a broad portfolio of the highest quality sealing solutions for their syringe systems. This includes elastomeric plunger stoppers, needle shields, and tip caps to seal the prefilled syringes as well as plungers and rubber-lined aluminum seals to ensure system integrity.
  • Product Medical Devices based on substances

    We develop and produce medical devices based on substances of class I, IIa and III.
    In particular:
    Oral Spray
    Nasal Spray
    Ear Spray
    Ear Drops
    Oral drops
    Oral solids (tablets and sachets)
    Vaginal Ovules
    Vaginal washes
    Eye drops (single an...
  • Product PLINEST - (POLYNUCLEOTIDES HPT™)

    PN HPT™ are deoxyribonucleotide polymers (DNA fractions) with a crucial role in: • Skin quality improvement • Restoring radiance and freshness • Promoting bio-regeneration • Reducing wrinkles and skin laxity

    The Polynucleotides with HPT™ PRIMING process prepare the skin and ...
  • Product ANTIBIOTIC INJECTABLES Meropenem(FOR CRITICAL CARE)

    CEFEPIME FOR INJECTION | CEFTRIAXONE | CEFTAZIDIME FOR INJECTION | CEFOPERAZONE + SULBACTAM FOR INJECTION | CEFUROXIME FOR INJECTION | CEFOTAXIME FOR INJECTION | CEFTAZIDIME AVIBACTAM FOR INJECTION | CEFTRIAXONE SULBACTAM FOR INJECTION | ELORES: CEFTRIAXONE, SULBACTAM & EDTA FOR INJECTION | AZTREONAM F...
  • Product Ceftriaxone for injection

    1Vial+1 ampoule of water for injection per box.
  • Product CordenPharma Peptides Platform

    Your Expert Partner for Peptide APIs
    • >> Proven track record delivering world class manufacturing services from early stage to commercial supply, including complex products (e.g., Linaclotide, Enfuvirtide, Mifamurtide, Eptifibatide, Glatiramer, GLP analogues). • >> Proprietary...
  • Product Huons Dental Cartridges

    Lidocaine HCl 2% + Epinephrine 1:100,000 Inj. Lidocaine HCl 2% + Epinephrine 1:80,000 Inj. Articaine HCl 4% + Epinephrine 1:100,000 Inj.
    Cartridge Ampoule packed Dental Anesthetics
    Currently exporting to more than 30 countries in the world.
    Looking for a capable importer/dist...
  • Product Injectables Products

    DifelikefalinEribulin
    Ferric Carboxymaltose
    Gadoterate Meglumine
  • Product INVIMA Approved Oncology

    Lodaat's Oncology Colombian INVIMA approved injectables with CTD dossier
  • Product Moxifloxacin Sol.Inf 400mg/250ml (250ml Bottle) (EU CTD Available)

    Moxifloxacin 400mg/250ml (250ml Bottle) Solution for Infusion
    Reference Product: Avelox® / BAYER
    Description: Moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones, works by killing bacteria that cause infections if they are caused by bacteria that are susceptible to Moxifloxa...
  • Product Zyfort

    Indications
    Neuralgia, polyneuritis, facial paresis, ischialgia, Vit. B deficiency

    Each ZYFORT ampoule contains:
    Thiamine HCl ……………100 mg
    Pyridoxine HCl ………….100 mg
    Cyanocobalamine …...5000 mcg

    Package : Box of 20 ampoules @ 3 ml

  • Product IV antibiotics

    • Metronidazole  • Moxifloxacine  • Levofloxacine 
  • Product Calcium carbonate + vit D3

    Calcium carbonate + vit D3 tablets
  • Product UV Light Blocking Tyvek Equipment Covers

    UV Light Blocking Tyvek Equipment Covers are designed to keep cleaned pharmaceutical equipment and supplies clean and protected from external sources of contamination while also providing in-process protection to light sensitive biotech products.
  • Product Zembrace®

    Zembrace® is a subcutaneous injection formulation of sumatriptan offering the lowest available dose of 3 mg of sumatriptan in a compact, easy to use auto-injection device which is currently on-market in the US.
  • Product Generic (Azithromycin)

    Azithromycin Tablets
    - Active substance(s): Azithromycin;
    - Pharmaceutical form(s): Tablets
    - Strength(s): 500 mg
    Azithromycin Powder
    - Active substance(s): Azithromycin;
    - Pharma...
  • Product Tio2 Free Capsules

    Especially for European Countries and the customers who follow EU norms, TiO2 free capsules are introduced to comply with their quality requirements.
  • Product ROSUMEGA®

    (1) Mixed Hyperlipidemia

    (2) Once daily, 2~4 soft capsules per day

    (3) Dual Effect to reduce LCL-C and TG Level by patented technology* (3-layer coating)

    (4) Combo’s additional decrease effect in residual cardiovascular risk & Omega-3’s multiple effects 
    (Lower...
  • Product Replasyn, Sodium hyaluronate MW 500-730 kDa

    Temporary synovial fluid supplementation in traumatic and
    degenerative joint disorders such as osteoarthritis effecting
    ankle, trapeziometacarpal joint, temporomandibular joint,
    knee, hip and shoulder. The product is indicated in the
    treatment of persistent pain after initial fa...
  • Product Tiroxil ® 0.4

    Dietary supplement for sub-clinical hyperthyroidism, with or without Grave’s disease
    • Clinical trials: One clinical trial demonstrates the effectiveness in reducing symptoms and improving quality of life of patients with subclinical hyperthyroidism. One clinical trial is ongoing which is asse...
  • Product UniSafe 1 mL

    A springless, passive safety device for 1mL pre-filled syringes, designed for simple assembly and use. Simple 2-step final assembly, Secure plunger prevents removal, spillage and repeat use. UniSafe 1mL has the following benefits:
    User confidence with an unobscured syringe barrel for full dose visibilit...
  • Product Cephalosporins APIs

    <API> Cefaclor Monohydrate Cefamandole Nafate Cefmetazole Sodium Cefotiam HCl / Cefotiam HCl+Na2CO3 Cefcapene Pivoxil HCl Cefdinir / Cefdinir Hydrate Cefditoren Pivoxil Cefpodoxime Proxetil Ceftazidime Pentahydrate Ceftizoxime Sodium Flomoxef Sodium Ceftaroline Fosamil *Ceftaroline Fosamil+L-Arginin...
  • Product PLATINOX for inj. (Oxaliplatin)


    Anti-cancer.

    It contains Oxaliplatin 50mg.

    Form:  Lyophilized.
  • Product Vega

    VEGA: Rotary washing machine

    Vega is a washing machine for bottles, vials, ampoules and unstable cylinder-shaped containers. Born to satisfy the most stringent market requirements, it is available in four different models featuring a continuous rotary motion to reach very high speeds while...
  • Product Torbener

    Active ingredient : Cefdinir 300mg , 125mg/5ml , 250mg/5ml

    Dosage Form : 
    Hard gelatin capsule & Suspension

    Category :
    3rd generation Broad spectrum cephalosporin antibiotic

    Indication :
    Pharyngitis & tonsillitis
    Acute bacterial otitis...
  • Product Carboprost Tromethamine Injection USP 125 mcg/1ml - FEMMEPROST

    Each Drop is important, stop bleeding after childbirth with carboprost

    Shree Venkatesh International Ltd offers a wide range of pharmaceutical products, including Carboprost Tromethamine Injection USP 125 mcg/1ml - FEMMEPROST
    • Use: Used to treat postpartum uterine hemorrhage due to ...
  • Product Propoliz Mouth Spray

    • A Natural Antibiotic Mouth Spray.  • Reduce infection in mouth and throat.  • Relieve sore throat. • Effective for both bacteria and virus. • Refresh the Bad breath.
  • Product Contract manufacturing services

    We manufacture, develop and consult. • Product portfolio: Tablets, film-coated tablets, suppositories, cremes, gels, ointments, capsules, Packaging • State-of-the-art GMP production facilities  • Manufacturing according to your individual requirements  • Blister and finished packaging, s...
  • Product Calsipar

    Paricalcitol 10 mcg/2ml - 5mcg/ml Solution for Inhection
  • Product RayDyLyo® Vial adapter

    ARaymondlife has developed the essential accessory for drug reconstitution, the vial adapter, one for each RayDyLyo diameter. The RayDyLyo® vial adapter is a medical device intended for the quick and safe reconstitution of drugs, contained in vials capped with RayDyLyo® plastic press fit caps, a...
  • Product Pharmaceutical Vials: Labelling and Packaging

    Our team of specialists can tailor our offering to manage the most complex packaging requirements. Our capabilities include: - Vial labelling, re-labelling and over-labelling - Cartoning of single and multi-packs - Cold chain packaging and storage - Kitting https://youtu.be/hzKBghVqFTc
  • Product EPHEDRINE INJECTION BP 30MG/ML & 50MG/ML

    EPHEDRINE INJECTION BP 30MG/ML & 50MG/ML Reversal of hypotension from spinal or epidural anaesthesia.
  • Product Inerta® Flexible Bags - Guaranteeing Drug Preservation Until Administra...

    The proven and recognized chemical inertia of the Inerta® polypropylene bags simplifies the packaging of drug solutions in a reliable, tried and tested container. Inerta® bags* are fully compliant with the requirements of European and American pharmaceutical regulations. They meet customer require...
  • Product Colistimethate sodium lyophilized vials

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

    Indication:&nbs...
  • Product Lidonostrum Bomba-Spray 10% (Lidocaine, cutaneous spray solution, 100 mg...

    Dosage strength: 100 mg/ml. Pharmaceutical form: cutaneous spray, solution.  Therapeutic indications:
    - Nasal procedures such as puncture of the maxillary sinus;
    - Oral and dental procedures prior to injection;
    - Oropharyngeal procedures such as gastrointestinal endoscopy;
    - Procedur...
  • Product SMART Flexi-Q eMU-P

    SMART Flexi-Q eMU-P is particularly suitable for use in long-term therapies that require frequent injections, such as multiple sclerosis, autoimmune conditions and blood disorders.

     The reusable design of SMART Flexi-Q eMU-P lowers cost per injection and reduces amount of materials for stor...
  • Product Cefodizime Sodium For Injection

    Jingxin Pharmaceutical offers a wide range of finished dosage forms products which includes cefodizime sodium for injection. It belongs to cephalosporin category. Contact us for more information.
  • Product Pronolis

    The first High Density (HD) Hyaluronic Acid gel: Complete and innovative range of viscosupplementation. Medical Device Class III
    • High quantity of hyaluronic acid, up to 120mg per syringe • High concentration, for a fast and prolonged pain relief • Unique Mono-shot HD hyaluronic acid specificificall...
  • Product INJECTABLES

    Requiring injectables.EU-GMP is a must.
    EU dossier is a must.
    Licensing and supply model or distributorship.
  • Product VIDVIR - REMDESIVIR 100 MG INJECTABLE

    Remdesivir injection is used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in hospitalized adults. Remdesivir is in a class of medications called antivirals. It works by stopping the virus from spreading in the body.
  • Product Ibuprofen 400 mg - SOLUBLE GRANULES

    Cold&Flu/PainkillerSoluble granules in sachet
    Available for outlicensing worldwide
    Contact us for more info
  • Product medEctoin Vaginal Gel

    Medical device for the relief of vagina dryness/ vaginal atrophy.  • Helps reduce inflammation of the vaginal mucosa • Immediately (10-15 minutes) hydrates dry and irritated vaginal mucosa and prevents further dehydration • Immediately relieves vaginal atrophy symptoms (within 5 days) such as i...
  • Product Promovia® Hydro Balance

    INJECTIONS Patented formulation featured of a mixture of sodium hyaluronate at medium and low molecular weights in concentration of 2,5% and 1% of Trehalose to extend the effectiveness and the duration of the treatment. 
    Promovia® Hydro Balance is available in two strengths: 
    Promovia®...
  • Product Betahistine Hydrochloride and Sodium Chloride Injection

    It is used for inner ear vertigo. It can also be used for postural vertigo and tinnitus caused by arteriosclerosis, ischemic cerebrovascular disease and hypertension.
  • Product Docetaxel AqVida 20 mg/ml concentrate for solution for infusion

    20 mg, 80 mg, 140 mg, 160 mg vial Indications: Treatment of breast cancer, special form of lung cancer, prostate cancer, gastric cancer and head or neck cancer
  • Product Glycopyrrolate injection

    Glycopyrronium (as the bromide salt glycopyrrolate) is a synthetic anticholinergic agent with a quaternary ammonium structure. A muscarinic competitive antagonist used as an antispasmodic, in some disorders of the gastrointestinal tract, and to reduce salivation with some anesthetics. 
    Strength:&nb...
  • Product Advanced PolyPropylene and PolyEthylene IV-bag Filling Tubes.

    Shock resistant at lower temperatures

     Sterilizable at 121°C

     Customizable widths

    Customizable thickness

    Class C clean room extrusion

    Class 100 filtered Air on the inside

    Plastic formulation excellence  ...
  • Product Liragliutide

    Liraglutide is a GLP-1 analog that binds to and activates the GLP-1 receptor, affecting appetite control and leading to weight loss. It also shows positive effects in cardiovascular tissues and can prevent the worsening of aortic plaques in animal models.