ANFARM HELLAS S.A.

About ANFARM HELLAS S.A.


Anfarm is a leading EU GMP Pharmaceuticals Manufacturer established in 1967, engaged in the development, production, licensing & sales of quality generic pharmaceuticals on a global scale. 
Our main activities include:
1. Licensing out & International Sales   
2. Tech Transfer & Contract Manufacturing3. Contract Development
4. New Product Development
5. Development / Optimization of Lyophilization Cycles  
6. Regulatory Affairs Services


ANFARM HELLAS S.A.

  • GR
  • 2015
    On CPhI since
Meet us at

CPhI Worldwide 2021

Fiera Milano, Milan, Italy
9-11 November 2021

Products from ANFARM HELLAS S.A.

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

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

    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
  • 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 transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults  for haemodynamically unstable PE patients.
    Dossier Status: On-going 
    Stability Studies: Zone II / Zone IVb
    Shelf life (Originator): Three (3) years
    Batch Size: To be defined
    Pack Sizes: To be defined / Originator pack: BT x 14, 20, 28, 56, 60, 168 and 200 film-coated tablets
  • 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 intravenous therapy is required and for the treatment of pelvic inflammatory disease (PID) due to susceptible microorganisms, in patients where initial intravenous therapy is required. 
    Dossier Status EU CTD Available 
    Stability Studies Zone II / Zone IVb 
    Shelf life: Three (3) years 
    Batch Size 22,640 vials 
    Pack Size BT x 1 vial
  • 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 years of age with epilepsy.
    Dossier Status: On-going (EU CTD Available: Q4 2022)
    Stability Studies: Zone II / Zone IVb
    Shelf life (Originator): Four (4) years
    Batch Size: To be defined
    Pack Sizes: To be defined / Originator pack: BT x 1 Glass Bottle.
  • 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 children from 4 years of age with epilepsy.
    Dossier Status: On-going (EU CTD Available: Q3 2022)
    Stability Studies: Zone II / Zone IVb
    Shelf life (Originator): Four (4) years
    Batch Sizes: 5,555 vials
    Pack Sizes: To be defined / Originator pack: BT x 10 vials.
  • 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 IVb
    Shelf life: Three (3) years
    Batch Sizes: 3,960 Bottles
    Pack Sizes: BT x 1 Bottle
  • 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 intolerant of amphotericin B, lipid formulations of amphotericin Band/or itraconazole and for the empirical therapy for presumed fungal infections (such as Candida or Aspergillus) infebrile, neutropaenic adult or pediatric patients.
    Dossier Status: EU CTD Available
    Stability Studies: Zone II / Zone IVb
    Shelf life: Two (2) years
    Batch Sizes: 3,000 (50mg) & 1,500 (70mg)
    Pack Sizes: BT x 1 vial
  • Ceftaroline Fosamil Pd.C.So.In 600mg/Vial (under development)

    Product Ceftaroline Fosamil Pd.C.So.In 600mg/Vial (under development)

    Ceftaroline Fosamil Powder for Concentrate for Solution for Infusion 600mg/vial
    Reference Product: Zinforo® / Pfizer
    Description: For the treatment of the following infections in neonates, infants, children, adolescents and adults, Complicated skin and soft tissue infections (cSSTI),  Community-acquired pneumonia (CAP), Consideration should be given to official guidance on the appropriate use of antibacterial agents.
    Dossier Status: On-going 
    Stability Studies: Zone II / Zone IVb
    Shelf life (Originator): Three (3) years
    Batch Size: To be defined
    Pack Sizes: To be defined / Originator pack: BT x 10 Vials
  • Ceftriaxone Ps.Inj.Sol 1g/Vial (IM, IV) (EU CTD Available)

    Product Ceftriaxone Ps.Inj.Sol 1g/Vial (IM, IV) (EU CTD Available)

    Ceftriaxone 1g/Vial Powder for Solution for Injection/Infusion 
    Reference Product: Farcef®  / Angelini
    Description: Ceftriaxone is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria: Lower Respiratory Tract Infections; Skin and Skin Structure Infections ; Complicated and Uncomplicated Urinary Tract Infections ; Pelvic Inflammatory Disease ; Bacterial Septicemia ; Bone and Joint Infections ; Intra-abdominal Infections ; Meningitis; and Surgical Prophylaxis.
    Dossier Status: EU CTD Available
    Stability Studies: Zone II / Zone IVb
    Shelf life: Two (2) years
    Batch Sizes: 42,052 vials
    Pack Sizes: Injection: BT x 1 vial
  • Cefuroxime  Pd.Inj.Sol 750mg/Vial & 1.5g/Vial (EU CTD Available)

    Product Cefuroxime Pd.Inj.Sol 750mg/Vial & 1.5g/Vial (EU CTD Available)

    Cefuroxime 750mg /Vial & 1.5g/Vial Powder for Solution for Injection 
    Reference Product: Zinadol® / GSK
    Description: Cefuroxime is an antibiotic used to treat certain infections caused by bacteria, including respiratory-tract infections such as tonsillitis and pharyngitis (infections of the throat), urinary-tract infections (infections of the structures that carry urine), skin infections, soft-tissue infections (infections of tissues just below the skin) and Lyme disease (bacterial infection transmitted to humans by infected ticks).
    Dossier Status: EU CTD Available
    Stability Studies: Zone II / Zone IVb
    Shelf life: Two (2) years
    Batch Sizes: 37.174 vials
    Pack Sizes: BT x 1 vial
  • Clarithromycin Pd.Sol.Inf. 500mg/Vial (EU CTD Available)

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

    Clarithromycin 500mg/Vial Powder for Solution for Infusion Reference Product: Klaricid® / ABBOTT
    Description: Clarithromycin has a longer serum half-life and better tissue penetration than erythromycin, allowing twice-a-day dosing for most common infections.  Clarithromycin as a powder for solution for infusion is indicated whenever parenteral therapy is required for treatment of infections caused by susceptible organisms in lower & upper respiratory tract infections and- Skin and soft tissue infections. 
    Dossier Status EU CTD Available 
    Stability Studies Zone II / Zone IVb 
    Shelf life: Three (3) years
    Batch Size 20.000 vials 
    Pack Size BT x 1 vial
  • Clindamycin Solution for Injection 150mg/ml (EU CTD Available: 2022)

    Product Clindamycin Solution for Injection 150mg/ml (EU CTD Available: 2022)

    Clindamycin 150mg/ml Solution for Injection (2ml & 4ml amps)  Dalacin® / PfizerDescription: Antibacterial.  Serious infections caused by susceptible Gram-positive organisms, staphylococci (both penicillinase- and non-penicillinase-producing), streptococci (except Streptococcus faecalis) and pneumococci. It is also indicated in serious infections caused by susceptible anaerobic pathogens such as Bacteroides spp, Fusobacterium spp, Propionibacterium spp, Peptostreptococcus spp. and microaerophilic streptococci.
    Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.
    Dossier Status: On-going / EU CTD Available: 2022
    Stability Studies: Zone II / Zone IVb
    Shelf life (Originator):   Two (2) years
    Batch Sizes: To be defined
    Pack Sizes: To be defined   
    Originator pack: Box x 1, 5 & 10 Ampoules. 

ANFARM HELLAS S.A. Resources