Synopsis
Synopsis
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USDMF
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
US Medicaid
NA
1. Grf(1-43)-oh
2. Growth Hormone Releasing Factor 43
3. Hpgrf(1-43)oh
4. Rat Growth Hormone-releasing Factor(1-43)
5. Rgrf 43
6. Rgrf(1-43)-oh
7. Rgrf(1-43)oh
8. Rhgrf(1-43)
9. Somaotropin Releasing Hormone (1-43)oh
10. Somatotropin Releasing Factor 43
1. 86472-71-1
2. Rgrf 43
3. Hpgrf(1-43)oh
4. Rhgrf(1-43)
5. Rgrf(1-43)-oh
6. Grf(1-43)-oh
7. Somatotropin Releasing Factor 43
8. Growth Hormone Releasing Factor 43
9. Somatropin Recombinant
10. Somaotropin Releasing Hormone (1-43)oh
11. Rat Growth Hormone-releasing Factor(1-43)
12. Dtxsid30235580
13. Somatoliberin (human Pancreatic Islet), 1-l-histidine-8-l-serine -12-l-arginine-13-l-isoleucine-18-l-tyrosine-24-l-histidine-25-l-glutamic Acid-28-l-asparagine-34-l-arginine-38-l-glutamine-39-l-arginine-40-l-serine-42-l-phenylalanine-43-l-asparagine-44-de-l-leucinamide-
Molecular Weight | 5234 g/mol |
---|---|
Molecular Formula | C225H360N76O67S |
XLogP3 | -23.5 |
Hydrogen Bond Donor Count | 86 |
Hydrogen Bond Acceptor Count | 79 |
Rotatable Bond Count | 189 |
Exact Mass | 5232.6886961 g/mol |
Monoisotopic Mass | 5230.6819865 g/mol |
Topological Polar Surface Area | 2440 Ų |
Heavy Atom Count | 369 |
Formal Charge | 0 |
Complexity | 13100 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 45 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
NDC Package Code : 62287-190
Start Marketing Date : 2015-03-04
End Marketing Date : 2027-01-29
Dosage Form (Strength) : POWDER, FOR SOLUTION (10mg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 84606-0824
Start Marketing Date : 2005-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER, FOR SOLUTION (10g/10g)
Marketing Category : BULK INGREDIENT
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About the Company : ENOMARK Group of Companies stands as a prominent Contract Manufacturer, boasting a cutting-edge manufacturing facility in Ahmadabad (Gujarat) that complies with WHO-GMP standards. ...
About the Company : Minglang chemical is owned by Minglang Group, is a large manufacturer of fine chemical and cosmetic materials that integrates R&D, production and sales together. It is located in t...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info :
Registration Country : USA
Brand Name : ZORBTIVE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 6MG/VIAL
Packaging :
Approval Date :
Application Number : 21597
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ZOMACTON
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL
Packaging :
Approval Date :
Application Number : 19774
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : NUTROPIN AQ PEN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/2ML (5MG/ML)
Packaging :
Approval Date :
Application Number : 20522
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : NutropinAq
Dosage Form : SOLUTION FOR INJECTION IN CARTRIDGE
Dosage Strength : 10 MG / 2 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Saizen Liquid
Dosage Form : Inj L?s
Dosage Strength : 6mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Somatotropin Releasing Hormone 1-43
Brand Name : Saizen
Dosage Form : Somatropin 1.33Mg 1 Unit Parenteral Use
Dosage Strength : 1 vial 1.33 mg 4 IU + 1 ampoule solv 1 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Canada
Brand Name : NORDITROPIN FLEXPRO
Dosage Form : SOLUTION
Dosage Strength : 10MG/1.5ML
Packaging :
Approval Date :
Application Number : 2529203
Regulatory Info :
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Norditropin Nordiflex 5 mg
Dosage Form : PED
Dosage Strength : 5mg/1,5 ml
Packaging : 1.5X1mg/1,5 ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Genotropin MiniQuick
Dosage Form :
Dosage Strength :
Packaging : 7
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Norway
Somatotropin Releasing Hormone 1-43
Brand Name : Omnitrope
Dosage Form : Injection fluid, resolution for SurePal 10
Dosage Strength : 10 mg/1.5 ml
Packaging : Sylinderampulle (glass) for SurePal 10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
RLD :
TE Code :
Brand Name : HUMATROPE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 12MG/VIAL
Approval Date :
Application Number : 19640
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : HUMATROPE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 24MG/VIAL
Approval Date :
Application Number : 19640
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : SEROSTIM LQ
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 6MG/0.5ML (6MG/0.5ML)
Approval Date :
Application Number : 20604
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : ZORBTIVE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4MG/VIAL
Approval Date :
Application Number : 21597
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : ZORBTIVE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL
Approval Date :
Application Number : 21597
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : ZOMACTON
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/VIAL
Approval Date :
Application Number : 19774
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : NUTROPIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL
Approval Date :
Application Number : 20168
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : NUTROPIN AQ NUSPIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/2ML (2.5MG/ML)
Approval Date :
Application Number : 20522
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : NORDITROPIN FLEXPRO
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 15MG/1.5ML
Approval Date :
Application Number : 21148
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : GENOTROPIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5.8MG/VIAL
Approval Date :
Application Number : 20280
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info :
Registration Country : Sweden
Brand Name : Zomacton
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 10 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Somatotropin Releasing Hormone 1-43
Brand Name : Zomacton
Dosage Form : Somatropin 4Mg 1 Unit Parenteral Use
Dosage Strength : 1 vial SC 4 mg + 1 ampoule solv 3.5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Somatotropin Releasing Hormone 1-43
Brand Name : Saizen
Dosage Form : Somatropin 12Mg 1.5 Ml 1 Units Parenteral Use
Dosage Strength : 1 cartridge SC 8 mg/ml 1,50 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Norditropin SimpleXx
Dosage Form : SOLUTION FOR INJECTION IN CARTRIDGE
Dosage Strength : 5 MG / 1.5 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Humatrope
Dosage Form : PULVER OCH VÄTSKA TILL INJEKTIONSVÄTSKA
Dosage Strength : 6 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Genotropin
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 0.2 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Somatotropin Releasing Hormone 1-43
Brand Name : Genotropin Miniqck Tubofiale
Dosage Form : Somatropin 1,8Mg 4 Units Parenteral Use
Dosage Strength : 4 tubofiale SC 1.8 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Somatotropin Releasing Hormone 1-43
Brand Name : Genotropin
Dosage Form : Powder and liquid to the injection fluid, resolution
Dosage Strength : 5 mg
Packaging : Tokammerampulle to pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Somatotropin Releasing Hormone 1-43
Brand Name : Omnitrope
Dosage Form : Somatropin 15Mg 1 Unit Parenteral Use
Dosage Strength : 1 cartridge for SurePal 15 mg/1.5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Somatotropin Releasing Hormone 1-43
Brand Name : Omnitrope
Dosage Form : Injection fluid, resolution
Dosage Strength : 5 mg/1.5 ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Canada
Brand Name : HUMATROPE
Dosage Form : LIQUID
Dosage Strength : 6MG
Packaging : 3.5 ML
Approval Date :
Application Number : 2243077
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : SAIZEN
Dosage Form : SOLUTION
Dosage Strength : 8MG/ML
Packaging : 1CART/5CART
Approval Date :
Application Number : 2350130
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : SAIZEN
Dosage Form : SOLUTION
Dosage Strength : 8MG/ML
Packaging : 1CART./5CART.
Approval Date :
Application Number : 2350149
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : NUTROPIN AQ NUSPIN 10
Dosage Form : SOLUTION
Dosage Strength : 10MG/2ML
Packaging : 1
Approval Date :
Application Number : 2376393
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : NORDITROPIN NORDIFLEX
Dosage Form : SOLUTION
Dosage Strength : 10MG/1.5ML
Packaging : 1.5ML PRE-FILLED PEN
Approval Date :
Application Number : 2334860
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : NORDITROPIN NORDIFLEX
Dosage Form : SOLUTION
Dosage Strength : 15MG/1.5ML
Packaging : 1.5ML
Approval Date :
Application Number : 2334879
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : GENOTROPIN
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 5.3MG/PEN
Packaging : 5
Approval Date :
Application Number : 2401703
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : GENOTROPIN
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 0.2MG/SYR
Packaging :
Approval Date :
Application Number : 2401746
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : GENOTROPIN
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1MG/SYR
Packaging : 7
Approval Date :
Application Number : 2401789
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : GENOTROPIN
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1.2MG/SYR
Packaging : 7
Approval Date :
Application Number : 2401797
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Saizen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Saizen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Saizen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Norditropin FlexPro
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Norditropin FlexPro
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Norditropin FlexPro
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Genotropin GoQuick
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Genotropin MiniQuick
Dosage Form :
Dosage Strength :
Packaging : 7
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Genotropin MiniQuick
Dosage Form :
Dosage Strength :
Packaging : 7
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Genotropin MiniQuick
Dosage Form :
Dosage Strength :
Packaging : 7
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Humatrope
Dosage Form : INJ
Dosage Strength : 6mg
Packaging : 3.15X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Humatrope
Dosage Form : INJ
Dosage Strength : 12mg
Packaging : 3.15X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Norditropin Nordiflex 5 mg
Dosage Form : PED
Dosage Strength : 5mg/1,5 ml
Packaging : 1.5X1mg/1,5 ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Norditropin Nordiflex 10 mg
Dosage Form : PED
Dosage Strength : 10mg/1,5 ml
Packaging : 1.5X1mg/1,5 ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Genotropin 16iu (5.3mg)
Dosage Form : INJ
Dosage Strength : 16iu/ml
Packaging : 1X5iu/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : OMNITROPE 10 mg/1,5 mℓ
Dosage Form : INJ
Dosage Strength : 10mg/1.5ml
Packaging : 1.5X1mg/1.5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : OMNITROPE 15 mg/1,5 mℓ
Dosage Form : INJ
Dosage Strength : 15mg/1.5ml
Packaging : 1.5X1mg/1.5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info :
Registration Country : Iran
Somatotropin Releasing Hormone 1-43
Brand Name : CinnaTropin
Dosage Form : Injectable
Dosage Strength : 5MG/1.5ML
Packaging : Pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging : Pen
Regulatory Info :
Somatotropin Releasing Hormone 1-43
Dosage : Injectable
Dosage Strength : 5MG/1.5ML
Brand Name : CinnaTropin
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 10IU
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : Iran
Somatotropin Releasing Hormone 1-43
Brand Name : PDgrowth
Dosage Form : Injection
Dosage Strength : 4IU/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Iran
Packaging :
Regulatory Info : Generic
Somatotropin Releasing Hormone 1-43
Dosage : Injection
Dosage Strength : 4IU/ML
Brand Name : PDgrowth
Approval Date :
Application Number :
Registration Country : Iran
Related Excipient Companies
Dosage Form : Orodispersible Tablet
Grade : Oral, Topical
Application : Disintegrants & Superdisintegrants
Excipient Details : Glycine is used as a disintegrant in solid dosage forms such as orally disintegrating tablets and in topical formulations such as emulsions & creams.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 75.07 g/mol
Ingredient(s) : Glycine Excipient
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives
Excipient Details : ACTILLETS™ are microcrystalline cellulose spheres used in advanced drug formulations as starter cores for drug layering and coating.
Pharmacopoeia Ref : NA
Technical Specs : Bulk density: 0.80
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Capsule
Grade : Oral
Dosage Form : Capsule
Grade : Oral
Dosage Form : Capsule
Grade : Oral
Brand Name : Microlose™ M60 P60
Application : Fillers, Diluents & Binders
Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Pharmacopoeia Ref : In-house
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Dosage Form : Capsule
Grade : Oral
Dosage Form : Gel
Grade : Parenteral, Oral, Topical
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Application : Solubilizers
Excipient Details : Poloxamer 188 is used as a solubilizer, emulsifier, stabilizer in parenteral, OSDs & topical formulations such as creams, gels & lotions.
Pharmacopoeia Ref : ChP/USP/EP
Technical Specs : Oxyethylene unit: 75%-85%, Oxypropylene unit: 25%-30%
Ingredient(s) : Poloxamer 188
Dosage Form : Capsule
Grade : Topical, Oral
Dosage Form : Cream / Lotion / Ointment
Grade : Parenteral, Oral, Topical
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : Histidine is used in biotherapeutic formulations and protects monoclonal antibodies in both the liquid and lyophilized state.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : pH 7.4
Ingredient(s) : L-Histidine Excipient
Dosage Form : Cream / Lotion / Ointment
Grade : Topical
Brand Name : 2-Phenoxyethanol Multi-Co...
Application : Topical
Excipient Details : A&C's 2-Phenoxyethanol is used as a preservative.
Pharmacopoeia Ref : Multi-Compendial Grade
Technical Specs : Not Available
Ingredient(s) : 2-Phenoxyethanol Excipient
Dosage Form : Cream / Lotion / Ointment
Grade : Topical
Brand Name : 2-Phenoxyethanol PhEur
Application : Topical
Excipient Details : A & C's 2-Phenoxyethanol is used as an excipient and meets the EP monograph
Pharmacopoeia Ref : PhEur
Technical Specs : Not Available
Ingredient(s) : 2-Phenoxyethanol Excipient
Dosage Form : Injectable / Parenteral
Grade : Parenteral and Topical
Application : Parenteral
Dosage Form : Cream / Lotion / Ointment
Grade : Oral, Parenteral
Brand Name : Benzyl Alcohol Multi-Comp...
Application : Topical
Excipient Details : A&C’s Benzyl Alcohol multi-compendial is a preservative which meets USP-NF, EP, BP and JP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Not Available
Ingredient(s) : Benzyl Alcohol Excipient
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Glycerol Multi-Compendial
Application : Parenteral
Excipient Details : A & C's Glycerol multi-compendial is an excipient that meets USP-NF, EP and BP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Not Available
Ingredient(s) : Glycerol Excipient
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : A & C's Glycerol is an excipient which meets the USP monograph.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Hydrochloric Acid NF
Application : Parenteral
Excipient Details : A&C's Hydrochloric Acid NF is used as a low pH neutralizing agent for pharmaceutical applications.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : NaCl Multi-compendial Low...
Application : Parenteral
Excipient Details : A & C's Sodium Chloride multi-compendial low endotoxin is an excipient meeting USP-NF, EP, BP and JP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Low Endotoxin
Ingredient(s) : Sodium Chloride Excipient
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Sodium Chloride USP
Application : Parenteral
Excipient Details : A & C's Sodium Chloride is an excipient meeting the USP monograph.
Dosage Form : Tablet
Grade : Not Available
Brand Name : Kolliphor P188 micro
Application : Direct Compression
Excipient Details : Dissolution enhancer, lubricant & wetting agent, Hydrophilic lubricant, effervescent tablets.
Pharmacopoeia Ref : Ph. Eur., USP-NF: Poloxamer 18...
Technical Specs : Not Available
Ingredient(s) : Microprilled Poloxamer
Dosage Form : Softgel Capsule
Grade : Not Available
Application : Solubilizers
Excipient Details : Nonionic solubilizer, emulsifier and co-emulsifier
Dosage Form : Orodispersible Tablet
Grade : Not Available
Application : Chewable & Orodispersible Aids
Excipient Details : Ludiflash is a ready-to-use orally disintegrating tablet (ODT) solution with superior mouthfeel.
Pharmacopoeia Ref : Ph. Eur., USP, JP: 90 % mannit...
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Dosage Form : Granule / Pellet
Grade : Not Available
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for tablets.
Dosage Form : Granule / Pellet
Grade : Not Available
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for lozenges, chewables and effervescent tablets.
Pharmacopoeia Ref : Ph. Eur., USP/NF and J.P
Technical Specs : Not Available
Ingredient(s) : Lactose
Excipients by Applications
Global Sales Information
Dosage Form :
Dosage Strength : 1 Cartridge Sc 12 Mg 36 Iu + 1 Syringe
Price Per Pack (Euro) : 576.98
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 1 Cartridge Sc 24 Mg 72 Iu + 1 Syringe
Price Per Pack (Euro) : 1153.96
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 1 Cartridge 10 Mg 1.5 Ml
Price Per Pack (Euro) : 685.76
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 1 Cartridge 15 Mg 1.5 Ml
Price Per Pack (Euro) : 1074.2
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form : Dry Sub
Dosage Strength : 5mg
Price Per Pack (Euro) : 155.79
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Dry Sub
Dosage Strength : 5mg
Price Per Pack (Euro) : 778.97
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 12mg
Price Per Pack (Euro) : 380.33
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 20mg
Price Per Pack (Euro) : 633.88
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj L?s
Dosage Strength : 6mg
Price Per Pack (Euro) : 190.16
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Inj Sol
Dosage Strength : 10mg
Price Per Pack (Euro) : 341.71
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Market Place
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12 Jun 2019
Patents & EXCLUSIVITIES
Patent Expiration Date : 2024-03-11
Date Granted : 2012-01-03
Brand Name : SAIZEN
Patent Number : 2516314
Filing Date : 2004-03-11
Strength per Unit : 6 mg
Dosage Form : Solution for injection
Human Or VET : Human
Route of Administration : Subcutaneous
Patent Expiration Date : 2024-03-11
Date Granted : 2012-01-03
Patent Expiration Date : 2024-03-11
Date Granted : 2012-01-03
Brand Name : SAIZEN
Patent Number : 2516314
Filing Date : 2004-03-11
Strength per Unit : 12 mg
Dosage Form : Solution for injection
Human Or VET : Human
Route of Administration : Subcutaneous
Patent Expiration Date : 2024-03-11
Date Granted : 2012-01-03
Patent Expiration Date : 2024-03-11
Date Granted : 2012-01-03
Brand Name : SAIZEN
Patent Number : 2516314
Filing Date : 2004-03-11
Strength per Unit : 20 mg
Dosage Form : Solution for injection
Human Or VET : Human
Route of Administration : Subcutaneous
Patent Expiration Date : 2024-03-11
Date Granted : 2012-01-03
Patent Expiration Date : 2011-05-31
Date Granted : 2005-02-01
Brand Name : NUTROPIN AQ
Patent Number : 2083159
Filing Date : 1991-05-31
Strength per Unit : 10mg/2ml
Dosage Form : Solution for Injection
Human Or VET : Human
Route of Administration : Subcutaneous
Patent Expiration Date : 2011-05-31
Date Granted : 2005-02-01
Patent Expiration Date : 2011-05-31
Date Granted : 2005-02-01
Brand Name : NUTROPIN AQ PEN CARTRIDGE
Patent Number : 2083159
Filing Date : 1991-05-31
Strength per Unit : 10mg/2ml
Dosage Form : Solution for Injection
Human Or VET : Human
Route of Administration : Subcutaneous
Patent Expiration Date : 2011-05-31
Date Granted : 2005-02-01
Patent Expiration Date : 2011-05-31
Date Granted : 2005-02-01
Brand Name : NUTROPIN
Patent Number : 2083159
Filing Date : 1991-05-31
Strength per Unit : 5mg
Dosage Form : Lyophilized Powder for Injection
Human Or VET : Human
Route of Administration : Subcutaneous or Intramuscular
Patent Expiration Date : 2011-05-31
Date Granted : 2005-02-01
Patent Expiration Date : 2011-05-31
Date Granted : 2005-02-01
Brand Name : NUTROPIN
Patent Number : 2083159
Filing Date : 1991-05-31
Strength per Unit : 10mg
Dosage Form : Lyophilized Powder for Injection
Human Or VET : Human
Route of Administration : Subcutaneous or Intramuscular
Patent Expiration Date : 2011-05-31
Date Granted : 2005-02-01
Patent Expiration Date : 2013-07-29
Date Granted : 2001-02-13
Brand Name : NUTROPIN AQ
Patent Number : 2139358
Filing Date : 1993-07-29
Strength per Unit : 10mg/2ml
Dosage Form : Solution for Injection
Human Or VET : Human
Route of Administration : Subcutaneous
Patent Expiration Date : 2013-07-29
Date Granted : 2001-02-13
Patent Expiration Date : 2011-01-25
Date Granted : 1994-01-25
Brand Name : HUMATROPE
Patent Number : 1326439
Filing Date : 1988-05-16
Strength per Unit : 1mg / 1ml vial
Dosage Form : Powder for Solution
Human Or VET : Human
Route of Administration : Subcutaneous, Intramuscular
Patent Expiration Date : 2011-01-25
Date Granted : 1994-01-25
Patent Expiration Date : 2011-08-02
Date Granted : 1994-08-02
Brand Name : HUMATROPE
Patent Number : 1331133
Filing Date : 1988-05-16
Strength per Unit : 1mg / 1ml vial
Dosage Form : Powder for Solution
Human Or VET : Human
Route of Administration : Subcutaneous, Intramuscular
Patent Expiration Date : 2011-08-02
Date Granted : 1994-08-02
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Somatropin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Somatropin, including repackagers and relabelers. The FDA regulates Somatropin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Somatropin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Somatropin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Somatropin supplier is an individual or a company that provides Somatropin active pharmaceutical ingredient (API) or Somatropin finished formulations upon request. The Somatropin suppliers may include Somatropin API manufacturers, exporters, distributors and traders.
click here to find a list of Somatropin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Somatropin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Somatropin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Somatropin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Somatropin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Somatropin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Somatropin suppliers with NDC on PharmaCompass.
Somatropin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Somatropin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Somatropin GMP manufacturer or Somatropin GMP API supplier for your needs.
A Somatropin CoA (Certificate of Analysis) is a formal document that attests to Somatropin's compliance with Somatropin specifications and serves as a tool for batch-level quality control.
Somatropin CoA mostly includes findings from lab analyses of a specific batch. For each Somatropin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Somatropin may be tested according to a variety of international standards, such as European Pharmacopoeia (Somatropin EP), Somatropin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Somatropin USP).
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