Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
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Europe
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Canada
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Australia
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
US Medicaid
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Annual Reports
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Regulatory FDF Prices
NA
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FDF
0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
1. Geref
2. Ghrh(1-29)nh2
3. Grf(1-29)nh2
4. Growth Hormone-releasing Factor(1-29)amide
5. Hghrh(1-29)nh2
6. Sermorelin
7. Somatotropin-releasing-hormone(1-29)amide
1. 114466-38-5
2. Ghrh (1-29)
3. Geref
4. Sermorelin Acetate [usan]
5. 114466-38-5 (acetate); 86168-78-7 (free Base).
6. H-tyr-ala-asp-ala-ile-phe-thr-asn-ser-tyr-arg-lys-val-leu-gly-gln-leu-ser-ala-arg-lys-leu-leu-gln-asp-ile-met-ser-arg-nh2
7. Unii-00ibg87iqw
8. 00ibg87iqw
9. Growth Hormone-releasing Factor (human)-(1-29)-peptide Amide, Acetate (salt), Hydrate
10. Sermorelin Acetateghrh (1-29)
11. Akos025311435
12. Somatoliberin (human Pancreatic Islet), 29-l-argininamide-30-de-l-glutamine-31-de-l-glutamine-32-deglycine-33-de-l-glutamic Acid-34-de-l-serine-35-de-l-asparagine-36-de-l-glutamine-37-de-l-glutamic Acid-38-de-l-arginine-39-deglycine-40-de-l-alanine-41-de-l-arginine-42-de-l-alanine-43-de-l-arginine-44-de-l-leucinamide-, Acetate (salt), Hydrate
13. 68s787
14. Ghrh (1-29);growth Hormone Releasing Factor Fragment 1-29 Amide Human
| Molecular Weight | 3417.9 g/mol |
|---|---|
| Molecular Formula | C151H250N44O44S |
| Hydrogen Bond Donor Count | 53 |
| Hydrogen Bond Acceptor Count | 51 |
| Rotatable Bond Count | 118 |
| Exact Mass | 3416.8431834 g/mol |
| Monoisotopic Mass | 3415.8398286 g/mol |
| Topological Polar Surface Area | 1510 Ų |
| Heavy Atom Count | 240 |
| Formal Charge | 0 |
| Complexity | 7670 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 31 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
API SUPPLIERS
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10293
Submission : 1993-06-11
Status : Inactive
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 : 82907-762
Start Marketing Date : 2024-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
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Digital Content
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Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 84347-005
Start Marketing Date : 2025-02-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
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Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 84789-106
Start Marketing Date : 2024-09-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 10695-200
Start Marketing Date : 2025-01-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 82907-762
Start Marketing Date : 2023-09-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 82907-762
Start Marketing Date : 2023-09-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 82907-762
Start Marketing Date : 2023-09-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 85134-004
Start Marketing Date : 2025-01-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
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Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10293
Submission : 1993-06-11
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 73212-012
Start Marketing Date : 2020-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-056
Start Marketing Date : 2015-06-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62991-2693
Start Marketing Date : 2008-07-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 70155-608
Start Marketing Date : 2017-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 10695-200
Start Marketing Date : 2025-01-28
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 82907-762
Start Marketing Date : 2024-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 82907-762
Start Marketing Date : 2023-09-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 82907-762
Start Marketing Date : 2023-09-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 84789-106
Start Marketing Date : 2024-09-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 85134-004
Start Marketing Date : 2025-01-14
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]FDF Dossiers
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GEREF
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1990-12-28
Application Number : 19863
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GEREF
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.5MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1997-09-26
Application Number : 20443
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GEREF
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1997-09-26
Application Number : 20443
Regulatory Info : DISCN
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : Yes
TE Code :
Brand Name : GEREF
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1990-12-28
Application Number : 19863
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : GEREF
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.5MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-09-26
Application Number : 20443
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : GEREF
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-09-26
Application Number : 20443
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Market Place
ABOUT THIS PAGE
76
PharmaCompass offers a list of Sermorelin 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 Sermorelin manufacturer or Sermorelin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sermorelin manufacturer or Sermorelin supplier.
PharmaCompass also assists you with knowing the Sermorelin API Price utilized in the formulation of products. Sermorelin API Price is not always fixed or binding as the Sermorelin Price is obtained through a variety of data sources. The Sermorelin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Geref manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Geref, including repackagers and relabelers. The FDA regulates Geref manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Geref 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 Geref manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Geref supplier is an individual or a company that provides Geref active pharmaceutical ingredient (API) or Geref finished formulations upon request. The Geref suppliers may include Geref API manufacturers, exporters, distributors and traders.
click here to find a list of Geref suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Geref DMF (Drug Master File) is a document detailing the whole manufacturing process of Geref active pharmaceutical ingredient (API) in detail. Different forms of Geref DMFs exist exist since differing nations have different regulations, such as Geref USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Geref DMF submitted to regulatory agencies in the US is known as a USDMF. Geref USDMF includes data on Geref's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Geref USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Geref 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 Geref as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Geref 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 Geref 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 Geref and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Geref NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Geref suppliers with NDC on PharmaCompass.
Geref 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 Geref 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 Geref GMP manufacturer or Geref GMP API supplier for your needs.
A Geref CoA (Certificate of Analysis) is a formal document that attests to Geref's compliance with Geref specifications and serves as a tool for batch-level quality control.
Geref CoA mostly includes findings from lab analyses of a specific batch. For each Geref 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.
Geref may be tested according to a variety of international standards, such as European Pharmacopoeia (Geref EP), Geref JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Geref USP).
