hameln pharmaceuticals


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specialists for pharmaceutical production

 

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See also

  • Product list

Product list

Our core products are aqueous solutions and suspensions. Gladly we manufacture for you the following products. Dossiers are already available. Please enquire about your own products.

Alpha lipoic acid infusion
Clindamycine injection
Dexamethason
Furosemide
Glyceryl trinitrate
Metoclopramid
Neostigmine
Pancuronium
Sodium chloride solution (0,9%)
Tramadol

Alpha lipoic acid infusion

  • API: alpha lipoic acid, meglumine-salt
    Therapeutic class: neurotropic medicine
  • Other ingredients: meglumine, macrogole 300, water for injections, nitrogen, argon
  • Containers: vial
  • Concentrations: 12 mg/ml - 50 ml vial
  • Dossier status: CTD Format module 3
  • Stability data: according to ICH Guidelines
    36 months
  • Packaging forms: packs of 5 or 10 vials
    infusion sets
  • Production: According to GMP standards.
    Our facilities are approved by all the relevant international health authorities - FDA and many more.

Alpha lipoic acid infusion

  • API: alpha lipoic acid, ethylenebis(azan)-salt
  • Therapeutic class: neurotropic medicine
  • Other ingredients:
    • concentrate for infusion:
      water for injections, nitrogen, argon
    • solution for infusion:
      ethylenediamine, sodium chloride,
      water for injections, nitrogen, argon
  • Containers: ampoule, vial
  • Concentrations: concentrate for infusion:
    25 mg/ml –24(25)ml ampoule
    25 mg/ml – 12(15) ml ampoule
  • Ready To Use solution for infusion:
    600 mg in a 100 ml vial
    600 mg in a 250 ml vial
  • Dossier status: CTD format module 3
  • Stability data: according to ICH Guidelines
    36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10 infusion sets for vials or ampoules
  • Production: according to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.

Clindamycine injection

  • API: clindamycine
  • Therapeutic class: antibiotic
  • Other ingredients: benzyl alcohol, sodium edetate, sodium hydroxide, water for injections
  • Containers: ampoule, vial
  • Concentrations: 150 mg/ml - 2 in 2 ml Ampoule
    150 mg/ml - 4 in 5 ml Ampoule
    150 mg/ml - 6 in 10 ml Ampoule
    150 mg/ml - 6 in 10 ml Vial
  • Dossier status: CTD format module 3
  • Stability data: according to ICH Guidelines.
    6 months for the vial
    9 months for the ampoules
    the stability studies will be continued
    up to 36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10
    single pack and packs of 10 for vials
  • Production: according to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.

Dexamethasone injection

  • API: dexamethasone sodium phosphate
  • Therapeutic class: adrenal hormones and synthetic substitutes
  • Other ingredients: propylene glycol, disodium edetate, sodium hydroxide, water for injections
  • Containers: ampoule
  • Concentrations: 4 mg/ml – 1 ml ampoule
    4 mg/ml – 2 ml ampoule
    8 mg/ml – 5 ml ampoule
    10 mg/ml – 10 ml ampoule
  • Dossier status: CTD format module 3
  • Stability data: according to ICH Guidelines
    36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10
  • Production: According to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.

Furosemide injection

  • API: furosemide
  • Therapeutic class: diuretic
  • Other ingredients: sodium hydroxide, sodium chloride, water for injections
  • Containers: ampoule
  • Concentrations: 10 mg/ml – 2 ml ampoule
    10 mg/ml – 4 ml ampoule
    10 mg/ml – 25 ml ampoule
  • Dossier: status CTD format module 3
  • Stability data: according to ICH Guidelines
    36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10
  • Production: according to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.

Glyceryl trinitrate infusion

  • API: glyceryl trinitrate
  • Therapeutic class: cardiovascular medicine
  • Other ingredients: water for injections, glucose monohydrate, hydrochloric acid
  • Containers: ampoule, vial
  • Concentrations: 1 mg/ml – 5 ml ampoule
    1 mg/ml – 10 ml ampoule
    1 mg/ml – 25 ml ampoule
    1 mg/ml – 50 ml vial
  • Dossier status: CTD format module 3
  • Stability data: according to ICH Guidelines
    18 months; the stability studies will be continued up to 36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10
    single pack and packs of 10 for vials
  • Production: according to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.

Metoclopramide injection

  • API: metoclopramide hydrochloride
  • Therapeutic class: antiemetic
  • Other ingredients: sodium chloride, citric acid,
    sodium citrate, hydrochloric acid, sodium hydroxide, water for injections
  • Containers: ampoule
  • Concentrations: 5 mg/ml – 2 ml ampoule
    5 mg/ml – 10 ml ampoule
  • Dossier status: CTD format module 3
  • Stability data: according to ICH Guidelines
    36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10
  • Production: according to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.

Neostigmine injection

  • API: neostigmine methylsulphate
  • Therapeutic class: cholinesterase inhibitors
  • Other ingredients: sodium chloride, water for injections
  • Containers: ampoule
  • Concentrations: 0.5 mg/ml – 1 ml ampoule
  • Dossier status: CTD format module 3
  • Stability data: according ICH Guidelines
    3 months; the stability studies will be continued up to 36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10
  • Production: According to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.

Pancuronium injection

  • API: pancuroniumbromid
  • Therapeutic class: muscle relaxant
  • Other ingredients: sodium acetate, sodium chloride, acetic acid, water for injections, nitrogen
  • Containers: ampoule
  • Concentrations: 2 mg/ml – 2 ml ampoule
  • Dossier status: CTD format module 3
  • Stability data: according to ICH Guidelines
    18 month; the stability studies will be continued up to 36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10
  • Production: according to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.

Sodium chloride solution

  • API: sodium chloride
  • Therapeutic class: diluents
  • Other ingredients: sodium chloride, hydrochloric acid,
    sodium hydroxide, water for injections
  • Containers: ampoule, vial
  • Concentrations: 9 mg/ml – 1 ml ampoule
    9 mg/ml – 1 ml in 2 ml ampoule
    9 mg/ml – 2 ml ampoule
    9 mg/ml – 5 ml ampoule
    9 mg/ml – 10 ml ampoule
    9 mg/ml – 20 ml ampoule
    9 mg/ml – 250 ml vial
  • Dossier status: CTD format module 3
  • Stability data: according to ICH Guidelines
    36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10,
    single pack for vials
  • Production: according to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.

Tramadol injection

  • API: tramadol hydrochloride
  • Therapeutic class: opioid analgesic
  • Other ingredients: sodium acetate, water for injections
  • Containers: ampoule
  • Concentrations: 50 mg/ml – 1 ml ampoule
    50 mg/ml – 2 ml ampoule
  • Dossier status: CTD format module 3
  • Stability data: according to ICH Guidelines
    3 months; the stability studies will be continued up to 36 months
  • Packaging forms: packs of 5 or 10 for ampoules,
    bundles of 10
  • Production: according to GMP standards.
    Our facilities are approved by all the relevant international authorities – FDA and many more.