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JDMF
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EU WC
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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 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41783
Submission : 2025-04-28
Status : Active
Type : II
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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 85717-001
Start Marketing Date : 2025-05-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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RLD :
TE Code :
Brand Name : HUMATROPE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2MG/VIAL
Approval Date :
Application Number : 19640
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : HUMATROPE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL
Approval Date :
Application Number : 19640
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : SAIZEN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4MG/VIAL
Approval Date :
Application Number : 19764
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : SEROSTIM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL
Approval Date :
Application Number : 20604
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : BIO-TROPIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4.8MG/VIAL
Approval Date :
Application Number : 19774
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : NORDITROPIN NORDIFLEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/1.5ML
Approval Date :
Application Number : 21148
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : NORDITROPIN NORDIFLEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/1.5ML
Approval Date :
Application Number : 21148
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : GENOTROPIN PRESERVATIVE FREE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1.5MG/VIAL
Approval Date :
Application Number : 20280
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : GENOTROPIN PRESERVATIVE FREE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2MG/VIAL
Approval Date :
Application Number : 20280
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : OMNITROPE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1.5MG/VIAL
Approval Date :
Application Number : 21426
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Nutropinaq
Dosage Form : Solution For Injection
Dosage Strength : 10mg/2ml
Packaging :
Approval Date : 16/02/2001
Application Number : 20010216000019
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Genotropin Mini Quick
Dosage Form : Solution For Injection
Dosage Strength : 0.6mg
Packaging :
Approval Date : 04/03/2004
Application Number : 20040304000041
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Norditropin Simplexx
Dosage Form : Solution For Injection
Dosage Strength : 10mg/1.5ml
Packaging :
Approval Date : 20/09/2017
Application Number : 20170105000022
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Somatotropin Releasing Hormone 1-43
Brand Name : Genotropin Miniqck Tubofiale
Dosage Form : Somatropin 1,4Mg 4 Units Parenteral Use
Dosage Strength : 4 tubofiale SC 1.4 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 in the finished filled syringe
Dosage Strength : 0.4 mg
Packaging : Two Chamber syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Genotropin
Dosage Form : Solution For Injection
Dosage Strength : 13.8mg
Packaging :
Approval Date : 21/04/2011
Application Number : 61421
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Somatotropin Releasing Hormone 1-43
Brand Name : Omnitrope
Dosage Form : Somatropin 10Mg 1.5 Ml 1 Units Parenteral Use
Dosage Strength : 1 cartridge for SurePal 10 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 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
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Omnitrope (Omnitrope Pen)
Dosage Form : Solution For Injection
Dosage Strength :
Packaging :
Approval Date : 20/04/2007
Application Number : 20060824000239
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Omnitrope (Surepal)
Dosage Form : Solution For Injection
Dosage Strength :
Packaging :
Approval Date : 17/07/2013
Application Number : 20140124000037
Regulatory Info : Approved
Registration Country : Sweden
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PharmaCompass offers a list of Somatropin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Somatropin manufacturer or Somatropin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Somatropin manufacturer or Somatropin supplier.
PharmaCompass also assists you with knowing the Somatropin API Price utilized in the formulation of products. Somatropin API Price is not always fixed or binding as the Somatropin Price is obtained through a variety of data sources. The Somatropin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A somatotropin releasing hormone (1-43) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of somatotropin releasing hormone (1-43), including repackagers and relabelers. The FDA regulates somatotropin releasing hormone (1-43) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. somatotropin releasing hormone (1-43) 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 somatotropin releasing hormone (1-43) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A somatotropin releasing hormone (1-43) supplier is an individual or a company that provides somatotropin releasing hormone (1-43) active pharmaceutical ingredient (API) or somatotropin releasing hormone (1-43) finished formulations upon request. The somatotropin releasing hormone (1-43) suppliers may include somatotropin releasing hormone (1-43) API manufacturers, exporters, distributors and traders.
click here to find a list of somatotropin releasing hormone (1-43) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A somatotropin releasing hormone (1-43) DMF (Drug Master File) is a document detailing the whole manufacturing process of somatotropin releasing hormone (1-43) active pharmaceutical ingredient (API) in detail. Different forms of somatotropin releasing hormone (1-43) DMFs exist exist since differing nations have different regulations, such as somatotropin releasing hormone (1-43) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A somatotropin releasing hormone (1-43) DMF submitted to regulatory agencies in the US is known as a USDMF. somatotropin releasing hormone (1-43) USDMF includes data on somatotropin releasing hormone (1-43)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The somatotropin releasing hormone (1-43) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of somatotropin releasing hormone (1-43) suppliers with USDMF 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 somatotropin releasing hormone (1-43) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for somatotropin releasing hormone (1-43) 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 somatotropin releasing hormone (1-43) 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 somatotropin releasing hormone (1-43) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a somatotropin releasing hormone (1-43) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of somatotropin releasing hormone (1-43) suppliers with NDC on PharmaCompass.
somatotropin releasing hormone (1-43) 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 somatotropin releasing hormone (1-43) 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 somatotropin releasing hormone (1-43) GMP manufacturer or somatotropin releasing hormone (1-43) GMP API supplier for your needs.
A somatotropin releasing hormone (1-43) CoA (Certificate of Analysis) is a formal document that attests to somatotropin releasing hormone (1-43)'s compliance with somatotropin releasing hormone (1-43) specifications and serves as a tool for batch-level quality control.
somatotropin releasing hormone (1-43) CoA mostly includes findings from lab analyses of a specific batch. For each somatotropin releasing hormone (1-43) 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.
somatotropin releasing hormone (1-43) may be tested according to a variety of international standards, such as European Pharmacopoeia (somatotropin releasing hormone (1-43) EP), somatotropin releasing hormone (1-43) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (somatotropin releasing hormone (1-43) USP).