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Chemistry

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Also known as: Dermatop, 73771-04-7, Hoe 777, Hoe-777, Dermatop e emollient, S-770777
Molecular Formula
C27H36O8
Molecular Weight
488.6  g/mol
InChI Key
FNPXMHRZILFCKX-KAJVQRHHSA-N
FDA UNII
V901LV1K7D

Prednicarbate
Prednicarbate is a synthetic non-halogenated double-ester derivative of the corticosteroid prednisolone with anti-inflammatory, antipruritic and vasoconstrictive properties. Following skin permeation, prednicarbate enters cells and binds to and activates specific nuclear receptors, resulting in an altered gene expression and inhibition of pro-inflammatory cytokine production by increasing the expression of lipocortins. These block phospholipase A-dependent release of arachidonic acid thereby inhibiting prostaglandin synthesis. This agent also decreases the number of circulating lymphocytes by suppression of the production of vasodilators such as prostacyclin and nitric oxide.
Prednicarbate is a Corticosteroid. The mechanism of action of prednicarbate is as a Corticosteroid Hormone Receptor Agonist.
1 2D Structure

Prednicarbate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[2-[(8S,9S,10R,11S,13S,14S,17R)-17-ethoxycarbonyloxy-11-hydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate
2.1.2 InChI
InChI=1S/C27H36O8/c1-5-22(31)34-15-21(30)27(35-24(32)33-6-2)12-10-19-18-8-7-16-13-17(28)9-11-25(16,3)23(18)20(29)14-26(19,27)4/h9,11,13,18-20,23,29H,5-8,10,12,14-15H2,1-4H3/t18-,19-,20-,23+,25-,26-,27-/m0/s1
2.1.3 InChI Key
FNPXMHRZILFCKX-KAJVQRHHSA-N
2.1.4 Canonical SMILES
CCC(=O)OCC(=O)C1(CCC2C1(CC(C3C2CCC4=CC(=O)C=CC34C)O)C)OC(=O)OCC
2.1.5 Isomeric SMILES
CCC(=O)OCC(=O)[C@]1(CC[C@@H]2[C@@]1(C[C@@H]([C@H]3[C@H]2CCC4=CC(=O)C=C[C@]34C)O)C)OC(=O)OCC
2.2 Other Identifiers
2.2.1 UNII
V901LV1K7D
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Batmen

2. Dermatop

3. Hoe 777

4. Hoe-777

5. Peitel

6. Prednisolone-17-ethylcarbonate-21-propionate

2.3.2 Depositor-Supplied Synonyms

1. Dermatop

2. 73771-04-7

3. Hoe 777

4. Hoe-777

5. Dermatop E Emollient

6. S-770777

7. Mls002154121

8. V901lv1k7d

9. Las189961

10. S 77 0777

11. S-77 0777

12. Las-189961

13. Nsc-760042

14. Peitel

15. Las-41003 Component Prednicarbate

16. Unii-v901lv1k7d

17. S-77-0777

18. Prednicarbato

19. Prednicarbatum

20. [2-[(8s,9s,10r,11s,13s,14s,17r)-17-ethoxycarbonyloxy-11-hydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Propanoate

21. Dermatop (tn)

22. Prednicarbate (usp/inn)

23. Prednicarbatum [inn-latin]

24. Prednicarbat

25. Prednicarbato [inn-spanish]

26. Ncgc00016926-01

27. Einecs 277-590-3

28. Prednicarbate [usan:usp:inn:ban]

29. Cas-73771-04-7

30. Prestwick0_001044

31. Prestwick1_001044

32. Prestwick2_001044

33. Prestwick3_001044

34. Prednicarbate [mi]

35. Prednicarbate [inn]

36. Schembl3941

37. Dsstox_cid_25502

38. Dsstox_rid_80919

39. Prednicarbate [usan]

40. Dsstox_gsid_45502

41. Bspbio_000968

42. Prednicarbate [vandf]

43. Prednicarbate [mart.]

44. S 770777

45. Spbio_002904

46. Prednicarbate [usp-rs]

47. Prednicarbate [who-dd]

48. Bpbio1_001066

49. Gtpl7605

50. Chembl1200386

51. Dtxsid9045502

52. Chebi:135791

53. Hms1571a10

54. Hms2098a10

55. Hms2230o11

56. Hms3715a10

57. Prednicarbate [orange Book]

58. Hy-b1365

59. Zinc3938652

60. Prednicarbate [ep Monograph]

61. Tox21_110687

62. Prednicarbate [usp Monograph]

63. Akos025402043

64. Prednicarbate For System Suitability A

65. Ac-3521

66. Ccg-221044

67. Db01130

68. Nsc 760042

69. 11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione 17-(ethyl Carbonate) 21-propionate

70. Ncgc00179357-01

71. Ncgc00179357-05

72. Pregna-1,4-diene-3,20-dione, 17-((ethoxycarbonyl)oxy)-11-hydroxy-21-(1-oxopropoxy)-, (11beta)-

73. Smr001233428

74. Ab00514017

75. Cs-0013106

76. D05601

77. 771p047

78. Sr-01000841201

79. Q-101379

80. Q4376623

81. Sr-01000841201-2

82. Brd-k46137903-001-03-3

83. 11.beta.,17,21-trihydroxypregna-1,4-diene-3,20-dione 17-(ethyl Carbonate) 21-propionate

84. Pregna-1,4-diene-3,20-dione, 17-((ethoxycarbonyl)oxy)-11-hydroxy-21-(1-oxopropoxy)-, (11.beta.)-

2.4 Create Date
2006-06-05
3 Chemical and Physical Properties
Molecular Weight 488.6 g/mol
Molecular Formula C27H36O8
XLogP34.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count8
Rotatable Bond Count9
Exact Mass488.24101810 g/mol
Monoisotopic Mass488.24101810 g/mol
Topological Polar Surface Area116 Ų
Heavy Atom Count35
Formal Charge0
Complexity982
Isotope Atom Count0
Defined Atom Stereocenter Count7
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameDermatop
PubMed HealthPrednicarbate (Topical application route)
Drug ClassesAdrenal Glucocorticoid, Corticosteroid, Intermediate
Drug LabelDERMATOP Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic...
Active IngredientPrednicarbate
Dosage FormOintment
RouteTopical
Strength0.1%
Market StatusPrescription
CompanyValeant Bermuda

2 of 6  
Drug NameDermatop e emollient
PubMed HealthPrednicarbate (Topical application route)
Drug ClassesAdrenal Glucocorticoid, Corticosteroid, Intermediate
Drug LabelDERMATOP Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic...
Active IngredientPrednicarbate
Dosage FormCream
RouteTopical
Strength0.1%
Market StatusPrescription
CompanyValeant Bermuda

3 of 6  
Drug NamePrednicarbate
Active IngredientPrednicarbate
Dosage FormOintment; Cream
RouteTopical
Strength0.1%
Market StatusPrescription
CompanyFougera Pharms

4 of 6  
Drug NameDermatop
PubMed HealthPrednicarbate (Topical application route)
Drug ClassesAdrenal Glucocorticoid, Corticosteroid, Intermediate
Drug LabelDERMATOP Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic...
Active IngredientPrednicarbate
Dosage FormOintment
RouteTopical
Strength0.1%
Market StatusPrescription
CompanyValeant Bermuda

5 of 6  
Drug NameDermatop e emollient
PubMed HealthPrednicarbate (Topical application route)
Drug ClassesAdrenal Glucocorticoid, Corticosteroid, Intermediate
Drug LabelDERMATOP Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic...
Active IngredientPrednicarbate
Dosage FormCream
RouteTopical
Strength0.1%
Market StatusPrescription
CompanyValeant Bermuda

6 of 6  
Drug NamePrednicarbate
Active IngredientPrednicarbate
Dosage FormOintment; Cream
RouteTopical
Strength0.1%
Market StatusPrescription
CompanyFougera Pharms

4.2 Drug Indication

For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin), and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various inhibitory enzymes responsible for the anti-inflammatory effects of topical corticosteroids. These anti-inflammatory effects include inhibition of early processes such as edema, fibrin deposition, capillary dilatation, movement of phagocytes into the area, and phagocytic activities. Later processes, such as capillary production, collagen deposition, and keloid formation also are inhibited by corticosteroids.


5.2 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)


Glucocorticoids

A group of CORTICOSTEROIDS that affect carbohydrate metabolism (GLUCONEOGENESIS, liver glycogen deposition, elevation of BLOOD SUGAR), inhibit ADRENOCORTICOTROPIC HORMONE secretion, and possess pronounced anti-inflammatory activity. They also play a role in fat and protein metabolism, maintenance of arterial blood pressure, alteration of the connective tissue response to injury, reduction in the number of circulating lymphocytes, and functioning of the central nervous system. (See all compounds classified as Glucocorticoids.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
PREDNICARBATE
5.3.2 FDA UNII
V901LV1K7D
5.3.3 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
5.4 ATC Code

D - Dermatologicals

D07 - Corticosteroids, dermatological preparations

D07A - Corticosteroids, plain

D07AC - Corticosteroids, potent (group iii)

D07AC18 - Prednicarbate


5.5 Absorption, Distribution and Excretion

Absorption

Absorbed systemically across the stratum corneum.


5.6 Metabolism/Metabolites

Primarily in skin


5.7 Mechanism of Action

In common with other topical corticosteroids, prednicarbate has anti-inflammatory, antipruritic, and vasoconstrictive properties. In general, the mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.


API SUPPLIERS

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Axplora

Germany

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EUROAPI

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Taro Pharmaceutical Industries

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Sicor de Mexico

Mexico

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Sicor de Mexico

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NEWCHEM SPA

Italy

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NEWCHEM SPA

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Curia

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Curia

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Guangzhou Topwork Chemical

China

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Symbiotica

Malaysia

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Symbiotica

Malaysia

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NEWCHEM SPA

Italy
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Prednicarbate

Registrant Name : Sungjin Exim Co., Ltd.

Registration Date : 2020-06-05

Registration Number : 20200605-211-J-650

Manufacturer Name : NEWCHEM SpA@IMS . SrI@Zhejia...

Manufacturer Address : Via Roveggia, 47-37136 Verona(VR) Italy@Via Venezia Giulia 23-20157 Milano(MI) Italy@...

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Symbiotica

Malaysia
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Symbiotica

Malaysia
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Prednicarbate

Registrant Name : Ace Biopharm Co., Ltd.

Registration Date : 2025-06-23

Registration Number : 20250623-211-J-1946

Manufacturer Name : Symbiotica Specialty Ingredi...

Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia@Middle of Hu...

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Listed Suppliers

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Axplora

Germany
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Prednicarbate

About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...

Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.
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EUROAPI

France
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Prednicarbate

About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...

EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our CDMO activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.
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03

Curia

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Curia

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About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...

Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, our suite of custom solutions allows us to tailor every engagement to your precise needs, whether that’s an independent project or an opportunity that cuts across the drug continuum.
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About the Company : Guangzhou Topwork Chemical Co., Ltd. Specializes in manufacturing corticosteroid and relative intermediates. We provide high quality products and excellent service to our clients a...

Guangzhou Topwork Chemical Co., Ltd. Specializes in manufacturing corticosteroid and relative intermediates. We provide high quality products and excellent service to our clients and have gained a high business reputation in the world market. Topwork gathers a group of energetic, hardworking and much experienced experts. They dedicate their entire efforts to research and development of new products. To guarantee the quality of our products, we have established an international standard quality control system. All of our products conform the latest standard of USP, EP, BP and CP.
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NEWCHEM SPA

Italy
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Italy
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Prednicarbate

About the Company : NEWCHEM is an independent Italian manufacturer of Active Pharmaceutical Ingredients (APIs) - Steroids, Progestogens, Prostafglandins. NEWCHEM is active on the worldwide Pharmaceut...

NEWCHEM is an independent Italian manufacturer of Active Pharmaceutical Ingredients (APIs) - Steroids, Progestogens, Prostafglandins. NEWCHEM is active on the worldwide Pharmaceutical Manufacturing market. Quality and reliability are guaranteed by the proven experience of EFFECHEM. NEWCHEM recruits only highly specialized personnel to work in compliance with the strictest regulations.The company is constantly updating its procedures to meet the most advanced quality and safety requirements.
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Symbiotica

Malaysia
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Symbiotica

Malaysia
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Prednicarbate

About the Company : Symbiotica is a Manufacturer of APIs from Malaysia with a cGMP Steroidal facility at Kulim, a Pioneer status from Malaysian Industrial Development Authority and P.I.C/S & W.H.O GMP...

Symbiotica is a Manufacturer of APIs from Malaysia with a cGMP Steroidal facility at Kulim, a Pioneer status from Malaysian Industrial Development Authority and P.I.C/S & W.H.O GMP certified as well as ISO 9001:2000 certified. USDMFs /CTDs have been filed on several products. We have CEPs for Dexamethasone sodium phosphate, Betamethasone valerate, Betamethasone Dipropionate, Clobetasol propionate, Mometasone furoate & Tibolone. Global Market segments include Regulated, Semi- Regulated & Non-regulated Markets. Other Key products are Betamethasones, Clobetasol, Deflazacort, Exemestane, Fluticasone, Fluocinonide.
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Prednicarbate

About the Company : Tianjin Tianfa Pharmaceutical Import & Export Co., Ltd. (Tianfa) was established in April 2000 and is jointly funded by Tianjin Pharmaceutical Group Co., Ltd. and Jinyao Pharmaceut...

Tianjin Tianfa Pharmaceutical Import & Export Co., Ltd. (Tianfa) was established in April 2000 and is jointly funded by Tianjin Pharmaceutical Group Co., Ltd. and Jinyao Pharmaceutical Co., Ltd. Specializing in the import and export of pharmaceuticals, we offer APIs, chemical preparations, antibiotics, and more. Our corticosteroid APIs, including dexamethasone and prednisone, are exported to over 40 countries. Ranked among Tianjin’s top 50 exporters, we continuously expand our global presence and welcome collaboration to drive mutual growth.
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - OINTMENT;TOPICAL - 0.1% **Federal Re...DOSAGE - OINTMENT;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19568

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DOSAGE - CREAM;TOPICAL - 0.1% **Federal Regis...DOSAGE - CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20279

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ABOUT THIS PAGE

Looking for 73771-04-7 / Prednicarbate API manufacturers, exporters & distributors?

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API | Excipient name

Prednicarbate

Synonyms

Dermatop, 73771-04-7, Hoe 777, Hoe-777, Dermatop e emollient, S-770777

Cas Number

73771-04-7

Unique Ingredient Identifier (UNII)

V901LV1K7D

About Prednicarbate

Prednicarbate is a synthetic non-halogenated double-ester derivative of the corticosteroid prednisolone with anti-inflammatory, antipruritic and vasoconstrictive properties. Following skin permeation, prednicarbate enters cells and binds to and activates specific nuclear receptors, resulting in an altered gene expression and inhibition of pro-inflammatory cytokine production by increasing the expression of lipocortins. These block phospholipase A-dependent release of arachidonic acid thereby inhibiting prostaglandin synthesis. This agent also decreases the number of circulating lymphocytes by suppression of the production of vasodilators such as prostacyclin and nitric oxide.

Peitel Manufacturers

A Peitel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Peitel, including repackagers and relabelers. The FDA regulates Peitel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Peitel 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 Peitel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Peitel Suppliers

A Peitel supplier is an individual or a company that provides Peitel active pharmaceutical ingredient (API) or Peitel finished formulations upon request. The Peitel suppliers may include Peitel API manufacturers, exporters, distributors and traders.

click here to find a list of Peitel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Peitel USDMF

A Peitel DMF (Drug Master File) is a document detailing the whole manufacturing process of Peitel active pharmaceutical ingredient (API) in detail. Different forms of Peitel DMFs exist exist since differing nations have different regulations, such as Peitel USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Peitel DMF submitted to regulatory agencies in the US is known as a USDMF. Peitel USDMF includes data on Peitel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Peitel USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Peitel suppliers with USDMF on PharmaCompass.

Peitel KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Peitel Drug Master File in Korea (Peitel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Peitel. The MFDS reviews the Peitel KDMF as part of the drug registration process and uses the information provided in the Peitel KDMF to evaluate the safety and efficacy of the drug.

After submitting a Peitel KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Peitel API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Peitel suppliers with KDMF on PharmaCompass.

Peitel CEP

A Peitel CEP of the European Pharmacopoeia monograph is often referred to as a Peitel Certificate of Suitability (COS). The purpose of a Peitel CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Peitel EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Peitel to their clients by showing that a Peitel CEP has been issued for it. The manufacturer submits a Peitel CEP (COS) as part of the market authorization procedure, and it takes on the role of a Peitel CEP holder for the record. Additionally, the data presented in the Peitel CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Peitel DMF.

A Peitel CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Peitel 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 Peitel suppliers with CEP (COS) on PharmaCompass.

Peitel NDC

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 Peitel as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Peitel API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Peitel 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Peitel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Peitel NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Peitel suppliers with NDC on PharmaCompass.

Peitel GMP

Peitel 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 Peitel 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 Peitel GMP manufacturer or Peitel GMP API supplier for your needs.

Peitel CoA

A Peitel CoA (Certificate of Analysis) is a formal document that attests to Peitel's compliance with Peitel specifications and serves as a tool for batch-level quality control.

Peitel CoA mostly includes findings from lab analyses of a specific batch. For each Peitel 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.

Peitel may be tested according to a variety of international standards, such as European Pharmacopoeia (Peitel EP), Peitel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Peitel USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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