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1. 15-methylprostaglandin F2alpha-tromethamine
2. Carboprost Trometamol
3. Hemabate
4. Prostin M-15
1. Hemabate
2. 58551-69-2
3. Carboprost Trometamol
4. Prostinfenem
5. Carboprost Trometanol
6. Carboprost (tromethamine)
7. U-32921e
8. U-32,921e
9. U4526f86fj
10. (z)-7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((e)-(3s)-3-hydroxy-3-methyl-1-octenyl)cyclopentyl)-5-heptenoic Acid Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
11. 2-amino-2-(hydroxymethyl)propane-1,3-diol;(z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(e,3s)-3-hydroxy-3-methyloct-1-enyl]cyclopentyl]hept-5-enoic Acid
12. 15-methyl Prostaglandin F2alpha
13. Prostin / 15m
14. Unii-u4526f86fj
15. Carboprost Tromethamine [usan]
16. Hemabate (tn)
17. Prostin/15
18. Carboprost Tromethamine [usan:usp]
19. U 32921e
20. Carboprost Tromethanimine
21. 15-methyl Pgf2 Alpha
22. Prostin/15m
23. 15(s)15-methyl Pgf2-alpha Tromethamine Salt
24. Carboprost Tromethamine Salt
25. Schembl433085
26. 15(s)15-methyl Prostaglandin F2-alpha Tromethamine
27. Carboprost Tromethamine (usp)
28. Chembl1237105
29. (15s)-15-methylprostaglandin F(sub 2alpha) Tromethamine
30. Dtxsid601015618
31. Hy-a0195
32. Carboprost Trometamol [mart.]
33. Akos037435222
34. Carboprost Trometamol [who-dd]
35. Carboprost Tromethamine [usp-rs]
36. Carboprost Tromethamine Salt [mi]
37. Carboprost Trometamol [ep Monograph]
38. Carboprost Tromethamine [orange Book]
39. Cs-0017541
40. Carboprost Tromethamine [usp Monograph]
41. D00682
42. E78557
43. U32921
44. 551c692
45. J-507750
46. Q18578732
47. (15s)-15-methylprostaglandin F(sub 2.alpha.) Tromethamine
48. (5z,9?,11?,15e,15s)-9,11,15-trihydroxy-15-methylprosta-5,13-dien-1-oic Acid Tris(hydroxymethyl)aminomethane Salt
49. 2-amino-2-(hydroxymethyl)propane-1,3-diol (e)-7-((1s,3s,5r)-3,5-dihydroxy-2-((s,z)-3-hydroxy-3-methyloct-1-en-1-yl)cyclopentyl)hept- 5-enoate
50. 2-amino-2-(hydroxymethyl)propane-1,3-diol (z)-7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((s,e)-3-hydroxy-3-methyloct-1-en-1-yl)cyclopentyl)hept-5-enoate
51. Prosta-5,13-dien-1-oic Acid, 9,11,15-trihydroxy-15-methyl-, (5z,9-alpha,11-alpha,13e,15s)-, Compd. With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
52. Prosta-5,13-dien-1-oic Acid, 9,11,15-trihydroxy-15-methyl-, (5z,9.alpha.,11.alpha.,13e,15s)-, Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
| Molecular Weight | 489.6 g/mol |
|---|---|
| Molecular Formula | C25H47NO8 |
| Hydrogen Bond Donor Count | 8 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 15 |
| Exact Mass | 489.33016746 g/mol |
| Monoisotopic Mass | 489.33016746 g/mol |
| Topological Polar Surface Area | 185 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 527 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 5 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 2 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Hemabate |
| PubMed Health | Carboprost Tromethamine (Injection) |
| Drug Classes | Endocrine-Metabolic Agent |
| Drug Label | HEMABATE Sterile Solution, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2 in a solution suitable for intramuscular injection.Carboprost tromethamine is the established name for th... |
| Active Ingredient | Carboprost tromethamine |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 0.25mg base/ml |
| Market Status | Prescription |
| Company | Pharmacia And Upjohn |
| 2 of 2 | |
|---|---|
| Drug Name | Hemabate |
| PubMed Health | Carboprost Tromethamine (Injection) |
| Drug Classes | Endocrine-Metabolic Agent |
| Drug Label | HEMABATE Sterile Solution, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2 in a solution suitable for intramuscular injection.Carboprost tromethamine is the established name for th... |
| Active Ingredient | Carboprost tromethamine |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 0.25mg base/ml |
| Market Status | Prescription |
| Company | Pharmacia And Upjohn |
Oxytocics
Drugs that stimulate contraction of the myometrium. They are used to induce LABOR, OBSTETRIC at term, to prevent or control postpartum or postabortion hemorrhage, and to assess fetal status in high risk pregnancies. They may also be used alone or with other drugs to induce abortions (ABORTIFACIENTS). Oxytocics used clinically include the neurohypophyseal hormone OXYTOCIN and certain prostaglandins and ergot alkaloids. (From AMA Drug Evaluations, 1994, p1157) (See all compounds classified as Oxytocics.)
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-01
Pay. Date : 2020-09-17
DMF Number : 33807
Submission : 2019-07-09
Status : Active
Type : II
Certificate Number : CEP 2023-336 - Rev 00
Issue Date : 2025-04-14
Type : Chemical
Substance Number : 1712
Status : Valid
NDC Package Code : 68245-0016
Start Marketing Date : 2018-12-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-01
Pay. Date : 2022-02-11
DMF Number : 35412
Submission : 2021-11-15
Status : Active
Type : II
NDC Package Code : 82231-103
Start Marketing Date : 2022-01-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : CN |
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37422
Submission : 2022-08-31
Status : Active
Type : II
NDC Package Code : 62227-023
Start Marketing Date : 2022-08-18
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-03
Pay. Date : 2017-10-06
DMF Number : 27865
Submission : 2014-01-27
Status : Active
Type : II
Certificate Number : R0-CEP 2021-354 - Rev 00
Issue Date : 2023-08-29
Type : Chemical
Substance Number : 1712
Status : Valid
Date of Issue : 2025-09-19
Valid Till : 2028-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0023
Start Marketing Date : 2014-05-19
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36373
Submission : 2021-10-14
Status : Active
Type : II



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GDUFA
DMF Review : Complete
Rev. Date : 2020-12-01
Pay. Date : 2020-09-17
DMF Number : 33807
Submission : 2019-07-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-01
Pay. Date : 2022-02-11
DMF Number : 35412
Submission : 2021-11-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37422
Submission : 2022-08-31
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-11-03
Pay. Date : 2017-10-06
DMF Number : 27865
Submission : 2014-01-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36373
Submission : 2021-10-14
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Certificate Number : CEP 2023-336 - Rev 00
Status : Valid
Issue Date : 2025-04-14
Type : Chemical
Substance Number : 1712
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Certificate Number : R0-CEP 2021-354 - Rev 00
Status : Valid
Issue Date : 2023-08-29
Type : Chemical
Substance Number : 1712

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Date of Issue : 2025-09-19
Valid Till : 2028-05-05
Written Confirmation Number : WC-0349
Address of the Firm : Unit-II, Sy. Nos. 50, 53, 53/A, 54 & 54/A,Kardanur (Village), Patancheru (Mandal...

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Details:
Through the acquisition of BSV, Mankind will enhance its pipelines including Endoprost (carboprost tromethamine), which is indicated for the treatment of post partum haemorrhage.
Lead Product(s): Carboprost Tromethamine,Inapplicable
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Endoprost
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Mankind Pharma
Deal Size: $1,637.3 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 23, 2024

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Lead Product(s) : Carboprost Tromethamine,Inapplicable
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Mankind Pharma
Deal Size : $1,637.3 million
Deal Type : Acquisition
Mankind Pharma Completes Landmark Acquisition of BSV
Details : Through the acquisition of BSV, Mankind will enhance its pipelines including Endoprost (carboprost tromethamine), which is indicated for the treatment of post partum haemorrhage.
Product Name : Endoprost
Product Type : Miscellaneous
Upfront Cash : Undisclosed
October 23, 2024

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Details:
Through the acquisition of BSV, Mankind will enhance its pipelines including Endoprost (Carboprost Tromethamine), which is indicated for the treatment of post partum haemorrhage.
Lead Product(s): Carboprost Tromethamine,Inapplicable
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Endoprost
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Mankind Pharma
Deal Size: $1,640.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition July 26, 2024

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Lead Product(s) : Carboprost Tromethamine,Inapplicable
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Mankind Pharma
Deal Size : $1,640.0 million
Deal Type : Acquisition
India's Mankind Pharma to Buy Bharat Serums in a $1.6 Billion Deal
Details : Through the acquisition of BSV, Mankind will enhance its pipelines including Endoprost (Carboprost Tromethamine), which is indicated for the treatment of post partum haemorrhage.
Product Name : Endoprost
Product Type : Miscellaneous
Upfront Cash : Undisclosed
July 26, 2024

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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : CARBOPROST TROMETHAMINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.25MG BASE/ML
Packaging :
Approval Date : 2019-07-02
Application Number : 211941
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Carboprost
Dosage Form : Injectable
Dosage Strength : 250 mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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Regulatory Info : RX
Registration Country : USA
Brand Name : CARBOPROST TROMETHAMINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.25MG BASE/ML
Packaging :
Approval Date : 2022-01-27
Application Number : 215337
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : CARBOPROST TROMETHAMINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.25MG BASE/ML
Packaging :
Approval Date : 2024-01-25
Application Number : 215901
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : CARBOPROST TROMETHAMINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.25MG BASE/ML
Packaging :
Approval Date : 2023-05-25
Application Number : 216939
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : CARBOPROST TROMETHAMINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.25MG BASE/ML
Packaging :
Approval Date : 2023-02-13
Application Number : 216882
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : CARBOPROST TROMETHAMINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.25MG BASE/ML
Packaging :
Approval Date : 2022-08-09
Application Number : 214499
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : HEMABATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.25MG BASE/ML
Packaging :
Approval Date : 1982-01-01
Application Number : 17989
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : CARBOPROST TROMETHAMINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.25MG BASE/ML
Packaging :
Approval Date : 2023-05-19
Application Number : 216824
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : CARBOPROST TROMETHAMINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 0.25MG BASE/ML
Packaging :
Approval Date : 2021-03-25
Application Number : 213118
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Carboprost Carefarm
Dosage Form : Injection Solution
Dosage Strength : 0.25mg/ml
Packaging :
Approval Date : 24-11-2023
Application Number : 28107022623
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Prostinfenem
Dosage Form : Injectable Solution
Dosage Strength : 0.25mg/ml
Packaging :
Approval Date : 08/11/1985
Application Number : 19851108000045
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Prostinphenem
Dosage Form : Injection Solution
Dosage Strength : 0.25mg/ml
Packaging :
Approval Date : 22-06-1987
Application Number : 28101179484
Regulatory Info : Prescription
Registration Country : Denmark

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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Carboprost
Dosage Form : Injectable
Dosage Strength : 250 mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info :
Dosage : Injectable
Dosage Strength : 250 mcg/ml
Brand Name : Carboprost
Approval Date :
Application Number :
Registration Country : India
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Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Ampoule
Dosage Strength : 250/500MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging :
Regulatory Info :
Dosage : Ampoule
Dosage Strength : 250/500MCG
Brand Name :
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : India
Brand Name : Carboprost Tromethamin...
Dosage Form : Liquid Injection
Dosage Strength : 250MCG/ML
Packaging : 5 ML, 1 ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging : 5 ML, 1 ML
Regulatory Info :
Dosage : Liquid Injection
Dosage Strength : 250MCG/ML
Brand Name : Carboprost Tromethamin...
Approval Date :
Application Number :
Registration Country : India

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
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Excipient Details : Tris (hydroxymethyl) aminomethane is used in electrophoresis, protein purification, enzyme assay, and as a buffering agent in biologics production.
Pharmacopoeia Ref : USP, EP, BP, ChP
Technical Specs : Low Endotoxin, Low Metals
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Grade : Topical, Parenteral
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Application : Parenteral, Topical
Excipient Details : It stabilizes the pH of solutions. It is also an enzyme inhibitor used in the biopharmaceutical industry.
Pharmacopoeia Ref : Not Available
Technical Specs : Bio Excipient Grade
Ingredient(s) : Tromethamine
Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral
Grade : Parenteral and Topical
Category : Parenteral, Topical
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Pharmacopoeia Ref : Multi-compendial
Technical Specs : Low Endotoxin
Ingredient(s) : Sodium Chloride Excipient
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Excipient Details : It stabilizes the pH of solutions. It is also an enzyme inhibitor used in the biopharmaceutical industry.
Pharmacopoeia Ref : Not Available
Technical Specs : Bio Excipient Grade
Ingredient(s) : Tromethamine
Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral
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Category : Parenteral, Topical
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PharmaCompass offers a list of Carboprost Tromethamine 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 Carboprost Tromethamine manufacturer or Carboprost Tromethamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Carboprost Tromethamine manufacturer or Carboprost Tromethamine supplier.
PharmaCompass also assists you with knowing the Carboprost Tromethamine API Price utilized in the formulation of products. Carboprost Tromethamine API Price is not always fixed or binding as the Carboprost Tromethamine Price is obtained through a variety of data sources. The Carboprost Tromethamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 15-Methyl PGF2 alpha manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 15-Methyl PGF2 alpha, including repackagers and relabelers. The FDA regulates 15-Methyl PGF2 alpha manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 15-Methyl PGF2 alpha 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 15-Methyl PGF2 alpha manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 15-Methyl PGF2 alpha supplier is an individual or a company that provides 15-Methyl PGF2 alpha active pharmaceutical ingredient (API) or 15-Methyl PGF2 alpha finished formulations upon request. The 15-Methyl PGF2 alpha suppliers may include 15-Methyl PGF2 alpha API manufacturers, exporters, distributors and traders.
click here to find a list of 15-Methyl PGF2 alpha suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 15-Methyl PGF2 alpha DMF (Drug Master File) is a document detailing the whole manufacturing process of 15-Methyl PGF2 alpha active pharmaceutical ingredient (API) in detail. Different forms of 15-Methyl PGF2 alpha DMFs exist exist since differing nations have different regulations, such as 15-Methyl PGF2 alpha USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 15-Methyl PGF2 alpha DMF submitted to regulatory agencies in the US is known as a USDMF. 15-Methyl PGF2 alpha USDMF includes data on 15-Methyl PGF2 alpha's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 15-Methyl PGF2 alpha USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 15-Methyl PGF2 alpha suppliers with USDMF on PharmaCompass.
A 15-Methyl PGF2 alpha CEP of the European Pharmacopoeia monograph is often referred to as a 15-Methyl PGF2 alpha Certificate of Suitability (COS). The purpose of a 15-Methyl PGF2 alpha CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 15-Methyl PGF2 alpha EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 15-Methyl PGF2 alpha to their clients by showing that a 15-Methyl PGF2 alpha CEP has been issued for it. The manufacturer submits a 15-Methyl PGF2 alpha CEP (COS) as part of the market authorization procedure, and it takes on the role of a 15-Methyl PGF2 alpha CEP holder for the record. Additionally, the data presented in the 15-Methyl PGF2 alpha CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 15-Methyl PGF2 alpha DMF.
A 15-Methyl PGF2 alpha CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 15-Methyl PGF2 alpha CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of 15-Methyl PGF2 alpha suppliers with CEP (COS) on PharmaCompass.
A 15-Methyl PGF2 alpha written confirmation (15-Methyl PGF2 alpha WC) is an official document issued by a regulatory agency to a 15-Methyl PGF2 alpha manufacturer, verifying that the manufacturing facility of a 15-Methyl PGF2 alpha active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 15-Methyl PGF2 alpha APIs or 15-Methyl PGF2 alpha finished pharmaceutical products to another nation, regulatory agencies frequently require a 15-Methyl PGF2 alpha WC (written confirmation) as part of the regulatory process.
click here to find a list of 15-Methyl PGF2 alpha suppliers with Written Confirmation (WC) 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 15-Methyl PGF2 alpha as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 15-Methyl PGF2 alpha 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 15-Methyl PGF2 alpha 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 15-Methyl PGF2 alpha and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 15-Methyl PGF2 alpha NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 15-Methyl PGF2 alpha suppliers with NDC on PharmaCompass.
15-Methyl PGF2 alpha 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 15-Methyl PGF2 alpha 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 15-Methyl PGF2 alpha GMP manufacturer or 15-Methyl PGF2 alpha GMP API supplier for your needs.
A 15-Methyl PGF2 alpha CoA (Certificate of Analysis) is a formal document that attests to 15-Methyl PGF2 alpha's compliance with 15-Methyl PGF2 alpha specifications and serves as a tool for batch-level quality control.
15-Methyl PGF2 alpha CoA mostly includes findings from lab analyses of a specific batch. For each 15-Methyl PGF2 alpha 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.
15-Methyl PGF2 alpha may be tested according to a variety of international standards, such as European Pharmacopoeia (15-Methyl PGF2 alpha EP), 15-Methyl PGF2 alpha JP (Japanese Pharmacopeia) and the US Pharmacopoeia (15-Methyl PGF2 alpha USP).