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27 API Suppliers
13 USDMF
6 EU WC
5 KDMF
10 NDC API
18 Listed Suppliers
$ API Reference Price

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84 Drugs in Development

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6 Intermediates Suppliers

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49 FDF Dossiers, 24 FDA Orange Book, 14 Europe, 3 Canada, 1 South Africa, 7 Listed Dossiers

49 FDF Dossiers
24 FDA Orange Book
14 Europe
3 Canada
1 South Africa
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MCG, TABLET;ORAL - 500MCG

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TABLET;ORAL - 250MCG
TABLET;ORAL - 500MCG

RELATED EXCIPIENT COMPANIES

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46 Fillers, Diluents & Binders
19 Direct Compression
10 Granulation
10 Co-Processed Excipients
8 Lubricants & Glidants
6 Solubilizers
5 Controlled & Modified Release
5 Disintegrants & Superdisintegrants
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2 US Medicaid Prescriptions, 13 Finished Drug Prices, 10 Annual Reports

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10 Annual Reports

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45 US Patents
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Roflumilast

Synopsis

ACTIVE PHARMA INGREDIENTS

27

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6

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10

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0

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18

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API REF. PRICE (USD/KG)

$

$ 158,313

MARKET PLACE

14

API

1

FDF

6INTERMEDIATES

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49

FDF Dossiers

24

FDA Orange Book

FDA (Orange Book)

14

Europe

3

Canada

0

Australia

1

South Africa

7

Listed Dossiers

84DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

5

Others

PATENTS & EXCLUSIVITIES

45

US Patents

4

US Exclusivities

4

Health Canada Patents

DIGITAL CONTENT

1

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

94

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

191,817,472

Annual Reports (USD Million)

1,443

Finished Drug Prices

76 RELATED EXCIPIENT COMPANIES

126EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 162401-32-3, Daxas, 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide, Daliresp, By217, Byk20869

Molecular Formula

C₁₇H₁₄Cl₂F₂N₂O₃

Molecular Weight

403.2 g/mol

InChI Key

MNDBXUUTURYVHR-UHFFFAOYSA-N

FDA UNII

0P6C6ZOP5U

Roflumilast

Roflumilast is an orally available, long-acting inhibitor of phosphodiesterase (PDE) type 4 (PDE4), with anti-inflammatory and potential antineoplastic activities. Upon administration, roflumilast and its active metabolite roflumilast N-oxide selectively and competitively bind to and inhibit PDE4, which leads to an increase of both intracellular levels of cyclic-3',5'-adenosine monophosphate (cAMP) and cAMP-mediated signaling. cAMP prevents phosphorylation of spleen tyrosine kinase (SYK) and abrogates activation of the PI3K/AKT/mTOR signaling pathway, which may result in the induction of apoptosis. PDE4, a member of the PDE superfamily that hydrolyses cAMP and 3',5'-cyclic guanosine monophosphate (cGMP) to their inactive 5' monophosphates, is upregulated in a variety of cancers and may contribute to chemoresistance; it also plays a key role in inflammation, especially in inflammatory airway diseases.

Roflumilast is a Phosphodiesterase 4 Inhibitor. The mechanism of action of roflumilast is as a Phosphodiesterase 4 Inhibitor.

1 2D Structure

Roflumilast

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

3-(cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide

2.1.2 InChI

InChI=1S/C17H14Cl2F2N2O3/c18-11-6-22-7-12(19)15(11)23-16(24)10-3-4-13(26-17(20)21)14(5-10)25-8-9-1-2-9/h3-7,9,17H,1-2,8H2,(H,22,23,24)

2.1.3 InChI Key

MNDBXUUTURYVHR-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CC1COC2=C(C=CC(=C2)C(=O)NC3=C(C=NC=C3Cl)Cl)OC(F)F

2.2 Other Identifiers

2.2.1 UNII

0P6C6ZOP5U

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 3-cyclopropylmethoxy-4-difluoromethoxy-n-(3,5-di-chloropyrid-4-yl)benzamide

2. Daliresp

2.3.2 Depositor-Supplied Synonyms

1. 162401-32-3

2. Daxas

3. 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide

4. Daliresp

5. By217

6. Byk20869

7. By-217

8. B9302-107

9. By 217

10. 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)benzamide

11. Roflumilast (daxas)

12. Benzamide, 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-

13. Byk-20869

14. 0p6c6zop5u

15. Chembl193240

16. Chebi:47657

17. 3-cyclopropylmethoxy-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide

18. Byk 20869

19. Mfcd00938270

20. B 9302-107

21. Rof

22. Libertek

23. Roflumilast [usan]

24. B-9302-107

25. Roflumilast [usan:inn]

26. Unii-0p6c6zop5u

27. Roflumilastum

28. Roflumilast (jan/usan/inn)

29. Apta-2217

30. 1xmu

31. 1xoq

32. Daliresp (tn)

33. Roflumilast- Bio-x

34. 3g4l

35. Roflumilast [mi]

36. Roflumilast [inn]

37. Roflumilast [jan]

38. 3-cyclopropylmethoxy-4-difluoromethoxy-n-(3,5-di-chloropyrid-4-yl)benzamide

39. Roflumilast [vandf]

40. Roflumilast [mart.]

41. Schembl19158

42. Roflumilast [who-dd]

43. Mls006010074

44. Roflumilast [ema Epar]

45. Gtpl6962

46. Dtxsid8044123

47. Apta 2217

48. Bdbm14774

49. Roflumilast, >=98% (hplc)

50. Amy4219

51. Ex-a059

52. Roflumilast [orange Book]

53. Hms3655p21

54. Hms3748c19

55. Hms3884f09

56. Zinc592419

57. Act02619

58. Bcp03736

59. S2131

60. Arq-151/zoryve (roflumilast Cream)

61. Akos005146309

62. Am84550

63. Ccg-268678

64. Cs-0963

65. Db01656

66. Pb29130

67. Ncgc00346566-01

68. Ncgc00346566-09

69. Ac-23383

70. As-14120

71. Br164364

72. Hy-15455

73. Smr002530074

74. Sy008710

75. Bcp0726000146

76. Ft-0660846

77. R0193

78. Sw220196-1

79. A24672

80. D05744

81. Ab01565852_02

82. 401r323

83. Q693482

84. J-510858

85. Brd-k03194791-001-02-2

86. 3- Cyclo-propylmethoxy-4-difluoromethoxy-n- [3, 5-di-chloropyrid-4-yl]- Benzamid

87. Benzamide, 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-

88. N-(3,5-dichloropyridin-4-yl)-4-difluoromethoxy-3-cyclopropylmethoxybenzamide

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₁₄Cl₂F₂N₂O₃
Molecular Weight	403.2 g/mol
XLogP3	4.6
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	7
Exact Mass	402.0349540 g/mol
Monoisotopic Mass	402.0349540 g/mol
Topological Polar Surface Area	60.4 Å²
Heavy Atom Count	26
Formal Charge	0
Complexity	475
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Daliresp
PubMed Health	Roflumilast (By mouth)
Drug Classes	Respiratory Agent
Drug Label	The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylm...
Active Ingredient	Roflumilast
Dosage Form	Tablet
Route	Oral
Strength	500mcg
Market Status	Prescription
Company	Forest Res Inst

2 of 2
Drug Name	Daliresp
PubMed Health	Roflumilast (By mouth)
Drug Classes	Respiratory Agent
Drug Label	The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylm...
Active Ingredient	Roflumilast
Dosage Form	Tablet
Route	Oral
Strength	500mcg
Market Status	Prescription
Company	Forest Res Inst

4.2 Drug Indication

Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

FDA Label

Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Chronic obstructive pulmonary disease

5 Pharmacology and Biochemistry

5.1 Pharmacology

Roflumilast (and its active metabolite, roflumilast N-oxide) increases cyclic adenosine-3, 5-monophosphate (cAMP) in lung cells by inhibiting PDE4. Increased cAMP activates PKA, which inactivates transcription factors involved in inflammation. Romflumilast also decreases the amount of sputum neutrophils and eosinophils in COPD patients.

5.2 FDA Pharmacological Classification

5.2.1 Active Moiety

ROFLUMILAST

5.2.2 FDA UNII

0P6C6ZOP5U

5.2.3 Pharmacological Classes

Phosphodiesterase 4 Inhibitors [MoA]; Phosphodiesterase 4 Inhibitor [EPC]

5.3 ATC Code

R03DX07

R03DX08

R03DX07

R03DX07

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

R - Respiratory system

R03 - Drugs for obstructive airway diseases

R03D - Other systemic drugs for obstructive airway diseases

R03DX - Other systemic drugs for obstructive airway diseases

R03DX07 - Roflumilast

5.4 Absorption, Distribution and Excretion

Absorption

After a 500mcg dose, the bioavailability of roflumilast is about 80%. In the fasted state, maximum plasma concentrations are reached in 0.5 to 2 hours. While in the fed state, Cmax is reduced by 40%, Tmax is increased by one hour, and total absorption is unchanged.

Route of Elimination

Roflumilast is excreted 70% in the urine as roflumilast N-oxide.

Volume of Distribution

Roflumilast has a Vd of 2.9L/kg with a dose of 500mcg. Permeability of roflumilast across the blood-brain barrier appears to be poor in rat studies.

Clearance

~9.6 L/hour.

5.5 Metabolism/Metabolites

Roflumilast is metabolized to roflumilast N-oxide, the active metabolite of roflumilast in humans, by CYP3A4 and CYP1A2.

5.6 Biological Half-Life

Plasma half-life of roflumilast is 17 hours and its metabolite is 30 hours (oral dose).

5.7 Mechanism of Action

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.

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C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"TO THE ORDER OF","customerCountry":"CHINA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"225000","totalValueFC":"222130.5","currency":"USD","unitRateINR":18497000,"date":"13-Nov-2023","totalValueINR":"18497000","totalValueInUsd":"222130.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"5328203","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719167400,"product":"ROFLUMILAST USP (AS PER INV)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. 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D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"CHINA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0005","unit":"KGS","unitRateFc":"1710000","totalValueFC":"876.1","currency":"USD","unitRateINR":"146835100","date":"26-Sep-2024","totalValueINR":"73417.55","totalValueInUsd":"876.1","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"5817747","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,M D,US 21704, UNITED STATES OF AMERIC A United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Europe

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2care4 Generics ApS

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2care4 Generics ApS

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AstraZeneca AB (2)

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AstraZeneca AG

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Orifarm AS

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Takeda GmbH

Japan

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08

Takeda GmbH

Japan

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09

TAKEDA GMBH

Japan

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 250MCG

USFDA APPLICATION NUMBER - 22522

DOSAGE - TABLET;ORAL - 500MCG

USFDA APPLICATION NUMBER - 22522

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ABOUT THIS PAGE

Roflumilast Manufacturers

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

Roflumilast Suppliers

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

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

Roflumilast USDMF

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

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

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

Roflumilast KDMF

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

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

After submitting a Roflumilast 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 Roflumilast API can apply through the Korea Drug Master File (KDMF).

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

Roflumilast WC

A Roflumilast written confirmation (Roflumilast WC) is an official document issued by a regulatory agency to a Roflumilast manufacturer, verifying that the manufacturing facility of a Roflumilast active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Roflumilast APIs or Roflumilast finished pharmaceutical products to another nation, regulatory agencies frequently require a Roflumilast WC (written confirmation) as part of the regulatory process.

click here to find a list of Roflumilast suppliers with Written Confirmation (WC) on PharmaCompass.

Roflumilast 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 Roflumilast as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Roflumilast 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 Roflumilast 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 Roflumilast and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Roflumilast NDC to their finished compounded human drug products, they may choose to do so.

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

Roflumilast GMP

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

Roflumilast CoA

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

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

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