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1. Anamorelin
1. 861998-00-7
2. Anamorelin Hcl
3. Anamorelin (hydrochloride)
4. Anamorelin Hydrochloride [usan]
5. Rc-1291 Hcl
6. Rc-1291 Hydrochloride
7. 55f75ljq0v
8. (3r)-1-((2r)-2-((2-amino-2-methylpropanoyl)amino)-3-(indol-3-yl)propanoyl)-3-benzyl-n,n',n'-trimethylpiperidine-3-carbohydrazide Hydrochloride
9. 3-piperidinecarboxylic Acid, 1-(2-methylalanyl-d-tryptophyl)-3-(phenylmethyl)-, Trimethylhydrazide, Monohydrochloride, (3r)-
10. Unii-55f75ljq0v
11. Ono-7643 Hydrochloride
12. Schembl4535148
13. Chembl2103794
14. Dtxsid70235443
15. Bcp15207
16. Anamorelin Hydrochloride (jan/usan)
17. Anamorelin Hydrochloride [mi]
18. Hy-14734a
19. Mfcd23098788
20. Anamorelin Hydrochloride [jan]
21. Akos030526940
22. Cs-1037
23. Anamorelin Hydrochloride [who-dd]
24. Ac-29222
25. D08856
26. Q27261306
27. 2-amino-n-((r)-1-((r)-3-benzyl-3-(1,2,2-trimethylhydrazine-1-carbonyl)piperidin-1-yl)-3-(1h-indol-3-yl)-1-oxopropan-2-yl)-2-methylpropanamide Hydrochloride
28. 2-amino-n-[(2r)-1-[(3r)-3-benzyl-3-[dimethylamino(methyl)carbamoyl]piperidin-1-yl]-3-(1h-indol-3-yl)-1-oxopropan-2-yl]-2-methylpropanamide;hydrochloride
| Molecular Weight | 583.2 g/mol |
|---|---|
| Molecular Formula | C31H43ClN6O3 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 9 |
| Exact Mass | 582.3085169 g/mol |
| Monoisotopic Mass | 582.3085169 g/mol |
| Topological Polar Surface Area | 115 Ų |
| Heavy Atom Count | 41 |
| Formal Charge | 0 |
| Complexity | 904 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Treatment of anorexia, cachexia or unintended weight loss in adult patients with non-small cell lung cancer (NSCLC)
Treatment of cancer related cachexia
V03
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31120
Submission : 2016-11-16
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30961
Submission : 2016-11-16
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 85941-023
Start Marketing Date : 2026-03-18
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

NDC Package Code : 71052-071
Start Marketing Date : 2024-09-19
End Marketing Date : 2030-04-01
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

NDC Package Code : 67262-0006
Start Marketing Date : 2014-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 85207-056
Start Marketing Date : 2026-03-18
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

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:
Adlumiz (anamorelin) is a selective, novel, orally active ghrelin receptor agonist. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism.
Lead Product(s): Anamorelin HCl,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Adlumiz
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Oberland Capital Management
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing January 10, 2023

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Lead Product(s) : Anamorelin HCl,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Oberland Capital Management
Deal Size : Undisclosed
Deal Type : Financing
Helsinn Closes Financing Agreement with Oberland Capital
Details : Adlumiz (anamorelin) is a selective, novel, orally active ghrelin receptor agonist. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism.
Product Name : Adlumiz
Product Type : Miscellaneous
Upfront Cash : Undisclosed
January 10, 2023

Details:
Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.
Lead Product(s): Anamorelin HCl,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Helsinn Advanced Synthesis | Quartesian
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 14, 2021

Lead Product(s) : Anamorelin HCl,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Helsinn Advanced Synthesis | Quartesian
Deal Size : Inapplicable
Deal Type : Inapplicable
Anamorelin Study for Advanced Pancreatic Cancer
Details : Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 14, 2021

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Details:
Marketing approval of Adlumiz® (generic name: anamorelin hydrochloride) Tablet 50mg (“Adlumiz”) is mainly based on the results from the ONO-7643-04 and ONO-7643-05 studies conducted in Japan in patients with cancer cachexia.
Lead Product(s): Anamorelin HCl,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Adlumiz
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 22, 2021

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Lead Product(s) : Anamorelin HCl,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
ONO Receives a Manufacturing and Marketing Approval of Adlumiz®, a Ghrelin Receptor Agonist for t...
Details : Marketing approval of Adlumiz® (generic name: anamorelin hydrochloride) Tablet 50mg (“Adlumiz”) is mainly based on the results from the ONO-7643-04 and ONO-7643-05 studies conducted in Japan in patients with cancer cachexia.
Product Name : Adlumiz
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 22, 2021

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Details:
Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Lead Product(s): Anamorelin HCl,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 15, 2018

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Lead Product(s) : Anamorelin HCl,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 15, 2018

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Details:
Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Lead Product(s): Anamorelin HCl,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 15, 2018

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Lead Product(s) : Anamorelin HCl,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 15, 2018

Details:
Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Cancer Cachexia.
Lead Product(s): Anamorelin HCl,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Helsinn Advanced Synthesis
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 09, 2012

Lead Product(s) : Anamorelin HCl,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Helsinn Advanced Synthesis
Deal Size : Inapplicable
Deal Type : Inapplicable
The Role of Ghrelin in Cancer Cachexia
Details : Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Cancer Cachexia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 09, 2012

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Details:
Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Lead Product(s): Anamorelin HCl,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 18, 2011

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Lead Product(s) : Anamorelin HCl,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 18, 2011

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Details:
Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Lead Product(s): Anamorelin HCl,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2011

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Lead Product(s) : Anamorelin HCl,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 04, 2011

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Details:
Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Lead Product(s): Anamorelin HCl,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2011

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Lead Product(s) : Anamorelin HCl,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Anamorelin HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Cachexia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 04, 2011

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
52
PharmaCompass offers a list of Anamorelin HCl API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Anamorelin HCl manufacturer or Anamorelin HCl supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Anamorelin HCl manufacturer or Anamorelin HCl supplier.
A Anamorelin hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anamorelin hydrochloride, including repackagers and relabelers. The FDA regulates Anamorelin hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anamorelin hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Anamorelin hydrochloride supplier is an individual or a company that provides Anamorelin hydrochloride active pharmaceutical ingredient (API) or Anamorelin hydrochloride finished formulations upon request. The Anamorelin hydrochloride suppliers may include Anamorelin hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Anamorelin hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Anamorelin hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Anamorelin hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Anamorelin hydrochloride DMFs exist exist since differing nations have different regulations, such as Anamorelin hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anamorelin hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Anamorelin hydrochloride USDMF includes data on Anamorelin hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anamorelin hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Anamorelin hydrochloride 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 Anamorelin hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Anamorelin hydrochloride 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 Anamorelin hydrochloride 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 Anamorelin hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Anamorelin hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Anamorelin hydrochloride suppliers with NDC on PharmaCompass.
Anamorelin hydrochloride 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 Anamorelin hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Anamorelin hydrochloride GMP manufacturer or Anamorelin hydrochloride GMP API supplier for your needs.
A Anamorelin hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Anamorelin hydrochloride's compliance with Anamorelin hydrochloride specifications and serves as a tool for batch-level quality control.
Anamorelin hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Anamorelin hydrochloride 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.
Anamorelin hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Anamorelin hydrochloride EP), Anamorelin hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Anamorelin hydrochloride USP).