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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

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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Product Web Link
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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 : 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

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Product Web Link
Virtual Booth
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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

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

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Details:
Somatropin is a Hormone drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Growth Disorders.
Lead Product(s): Somatropin,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 26, 2023

Lead Product(s) : Somatropin,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Details : Somatropin is a Hormone drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Growth Disorders.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Inapplicable
October 26, 2023

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Details:
Somatropin is a Hormone drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Prader-Willi Syndrome.
Lead Product(s): Somatropin,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 06, 2021

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Lead Product(s) : Somatropin,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS
Details : Somatropin is a Hormone drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Prader-Willi Syndrome.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Inapplicable
January 06, 2021

Details:
Somatropin is a Hormone drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Aging.
Lead Product(s): Somatropin,Metformin,Dehydroepiandrosterone
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Hormone
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 05, 2020

Lead Product(s) : Somatropin,Metformin,Dehydroepiandrosterone
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
Details : Somatropin is a Hormone drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Aging.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Inapplicable
May 05, 2020

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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 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.
A Somatropin DMF (Drug Master File) is a document detailing the whole manufacturing process of Somatropin active pharmaceutical ingredient (API) in detail. Different forms of Somatropin DMFs exist exist since differing nations have different regulations, such as Somatropin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Somatropin DMF submitted to regulatory agencies in the US is known as a USDMF. Somatropin USDMF includes data on Somatropin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Somatropin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Somatropin 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 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).