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Chemistry

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Also known as: 130209-82-4, Xalatan, Phxa41, Phxa-41, Xa41, Phxa 41
Molecular Formula
C26H40O5
Molecular Weight
432.6  g/mol
InChI Key
GGXICVAJURFBLW-CEYXHVGTSA-N
FDA UNII
8S5FB3XXG8

Latanoprost
A prostaglandin F analog used to treat OCULAR HYPERTENSION in patients with GLAUCOMA.
Latanoprost is a Prostaglandin Analog.
1 2D Structure

Latanoprost

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
propan-2-yl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate
2.1.2 InChI
InChI=1S/C26H40O5/c1-19(2)31-26(30)13-9-4-3-8-12-22-23(25(29)18-24(22)28)17-16-21(27)15-14-20-10-6-5-7-11-20/h3,5-8,10-11,19,21-25,27-29H,4,9,12-18H2,1-2H3/b8-3-/t21-,22+,23+,24-,25+/m0/s1
2.1.3 InChI Key
GGXICVAJURFBLW-CEYXHVGTSA-N
2.1.4 Canonical SMILES
CC(C)OC(=O)CCCC=CCC1C(CC(C1CCC(CCC2=CC=CC=C2)O)O)O
2.1.5 Isomeric SMILES
CC(C)OC(=O)CCC/C=C\C[C@H]1[C@H](C[C@H]([C@@H]1CC[C@H](CCC2=CC=CC=C2)O)O)O
2.2 Other Identifiers
2.2.1 UNII
8S5FB3XXG8
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Phxa34

2. Phxa41

3. Xalatan

2.3.2 Depositor-Supplied Synonyms

1. 130209-82-4

2. Xalatan

3. Phxa41

4. Phxa-41

5. Xa41

6. Phxa 41

7. Xa-41

8. Latanoprost (isopropyl Ester)

9. Isopropyl (z)-7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((3r)-3-hydroxy-5-phenylpentyl)cyclopentyl)-5-heptenoate

10. Propan-2-yl (z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate

11. Latanoprost, (+/-)-

12. 6z5b6hvf6o

13. 8s5fb3xxg8

14. Latanoprost, Ethanol Solution

15. Chebi:6384

16. Propan-2-yl (5z)-7-{(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl}hept-5-enoate

17. T-2345

18. T2345

19. 5-heptenoic Acid, 7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]-, 1-methylethyl Ester, (5z)-

20. Isopropyl (5z,9alpha,11alpha,15r)-9,11,15-trihydroxy-17-phenyl-18,19,20-trinorprost-5-en-1-oate

21. Catioprost

22. (z)-isopropyl 7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((r)-3-hydroxy-5-phenylpentyl)cyclopentyl)hept-5-enoate

23. 155551-81-8

24. 5-heptenoic Acid, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenylpentyl)cyclopentyl)-, 1-methylethyl Ester

25. Smr000466354

26. Xalatan (tn)

27. Unii-6z5b6hvf6o

28. Latanoprostum

29. Nova-21027

30. Latanoprost [usan:inn:ban]

31. Xa 41

32. Phxa34 [as 15(r,s)-isomer]

33. Propan-2-yl (5z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate

34. Ar-202

35. Mfcd00216074

36. Xelpros

37. L-ppds

38. Latanoprost [mi]

39. Latanoprost [inn]

40. Latanoprost [jan]

41. Latanoprost [usan]

42. Unii-8s5fb3xxg8

43. Latanoprost [vandf]

44. Chembl1051

45. Latanoprost [mart.]

46. Schembl24698

47. Latanoprost [usp-rs]

48. Latanoprost [who-dd]

49. Mls000759468

50. Mls001424106

51. Latanoprost (jan/usp/inn)

52. Gtpl1961

53. Dtxsid1041057

54. Latanoprost [orange Book]

55. Hms2051h11

56. Hms2089j17

57. Hms3715n22

58. Latanoprost [ep Monograph]

59. Latanoprost [usp Monograph]

60. Amy30089

61. Ex-a1770

62. Hy-b0577

63. Xalacom Component Latanoprost

64. Bdbm50240648

65. S4709

66. Zinc12468792

67. Latanoprost, >=98% (hplc), Oil

68. Rocklatan Component Latanoprost

69. Akos024458331

70. Ccg-100946

71. Db00654

72. Nc00196

73. Latanoprost Component Of Rocklatan

74. Ncgc00246969-01

75. Ncgc00246969-06

76. (5z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptanoic Acid 1-methylethyl Ester

77. As-75099

78. L0262

79. D00356

80. Ab00640005-04

81. Ab00640005-06

82. 209l824

83. A806039

84. Q634959

85. Sr-01000759428

86. J-005764

87. Sr-01000759428-4

88. Latanoprost, United States Pharmacopeia (usp) Reference Standard

89. Tris(2,4-dimethylphenyl)phosphine-5,5',5""""-trisulfonic Acid Trisodium Salt

90. (1r,2r,3r,5s,3''r)-7-[3,5-dihydroxy-2-(3-hydroxy-5-phenyl-pentyl)-cyclopentyl]-hept-5-enoic Acid Isopropyl Ester

91. (z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoic Acid Propan-2-yl Ester

92. 5-heptenoic Acid, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenylpentyl)cyclopentyl)-, 1-methylethyl Ester, (1r-(1-alpha(z),2-beta(r*),3-alpha,5-alpha))-

93. 5-heptenoic Acid, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenylpentyl)cyclopentyl)-1-methylethyl Ester, (1r-(1.alpha.(z),2.beta.(r*),3.alpha.,5.alpha.))-

94. Isopropyl (5z,9alpha,11alpha,15r)-9,11,15-trihydroxy-17-phenyl-18,19,20-trinor-prost-5-en-1-oate;xalatan

95. Propan-2-yl (z)-7-[(1r,2r,3r,5s)-3,5-bis(oxidanyl)-2-[(3r)-3-oxidanyl-5-phenyl-pentyl]cyclopentyl]hept-5-enoate

2.4 Create Date
2005-12-16
3 Chemical and Physical Properties
Molecular Weight 432.6 g/mol
Molecular Formula C26H40O5
XLogP34.3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count14
Exact Mass432.28757437 g/mol
Monoisotopic Mass432.28757437 g/mol
Topological Polar Surface Area87 Ų
Heavy Atom Count31
Formal Charge0
Complexity526
Isotope Atom Count0
Defined Atom Stereocenter Count5
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameLatanoprost
PubMed HealthLatanoprost (Into the eye)
Drug ClassesAntiglaucoma
Drug LabelLatanoprost is a prostaglandin F2 analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is:Latanoprost is a...
Active IngredientLatanoprost
Dosage FormSolution/drops; Solution
RouteOphthalmic; ophthalmic
Strength0.005%
Market StatusTentative Approval; Prescription
CompanyAlcon Res; Par Pharm; Bausch And Lomb; Luitpold; Dr Reddys Labs; Mylan; Akorn

2 of 4  
Drug NameXalatan
PubMed HealthLatanoprost (Into the eye)
Drug ClassesAntiglaucoma
Drug LabelLatanoprost is a prostaglandin F2 analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is:Latanoprost is a...
Active IngredientLatanoprost
Dosage FormSolution/drops
RouteOphthalmic
Strength0.005%
Market StatusPrescription
CompanyPharmacia And Upjohn

3 of 4  
Drug NameLatanoprost
PubMed HealthLatanoprost (Into the eye)
Drug ClassesAntiglaucoma
Drug LabelLatanoprost is a prostaglandin F2 analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is:Latanoprost is a...
Active IngredientLatanoprost
Dosage FormSolution/drops; Solution
RouteOphthalmic; ophthalmic
Strength0.005%
Market StatusTentative Approval; Prescription
CompanyAlcon Res; Par Pharm; Bausch And Lomb; Luitpold; Dr Reddys Labs; Mylan; Akorn

4 of 4  
Drug NameXalatan
PubMed HealthLatanoprost (Into the eye)
Drug ClassesAntiglaucoma
Drug LabelLatanoprost is a prostaglandin F2 analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is:Latanoprost is a...
Active IngredientLatanoprost
Dosage FormSolution/drops
RouteOphthalmic
Strength0.005%
Market StatusPrescription
CompanyPharmacia And Upjohn

4.2 Drug Indication

Latanoprost is indicated for the reduction of elevated intraocular pressure in patients who have been diagnosed with open-angle glaucoma or ocular hypertension. Latanoprost may be combined in a product with [Netarsudil], a rho kinase inhibitor, for the same indications. In addition to the above indications, the Canadian monograph for this drug also approves latanoprost for the treatment of elevated intraocular pressure as a result of angle-closure glaucoma that has been treated with peripheral iridotomy or laser iridoplasty.


FDA Label


Treatment of glaucoma


5 Pharmacology and Biochemistry
5.1 Pharmacology

Latanoprost effectively decreases intraocular pressure by increasing uveoscleral outflow. A decrease in intraocular pressure has been measured within 34 hours post-administration, reaches a maximum decrease at 812 hours, and can be maintained for a period of 24 hours. **A note on eye and periorbital changes** Between 3 to 10% of patients taking latanoprost have experienced iris pigmentation after about 3-4 months of latanoprost use. Patients should be notified of this risk before initiating treatment. It may occur in both patients with light-colored irides (green-brown or blue/grey-brown) or dark-colored (brown) irides, but is less pronounced in the latter group. This drug may also cause other ocular effects including infrequent conjunctival hyperemia, pigmentation of periocular tissues, eyelash changes, hypertrichosis, and ocular irritation.


5.2 MeSH Pharmacological Classification

Ophthalmic Solutions

Sterile solutions that are intended for instillation into the eye. It does not include solutions for cleaning eyeglasses or CONTACT LENS SOLUTIONS. (See all compounds classified as Ophthalmic Solutions.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
LATANOPROST
5.3.2 FDA UNII
6Z5B6HVF6O
5.3.3 Pharmacological Classes
Prostaglandins [CS]; Prostaglandin Analog [EPC]
5.4 ATC Code

S01EE01

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


S - Sensory organs

S01 - Ophthalmologicals

S01E - Antiglaucoma preparations and miotics

S01EE - Prostaglandin analogues

S01EE01 - Latanoprost


5.5 Absorption, Distribution and Excretion

Absorption

This drug is rapidly absorbed in the cornea as an isopropyl ester prodrug and is then activated by the process of hydrolysis. A small amount of this drug is systemically absorbed. The Cmax of latanoprost in the systemic circulation is reached after 5 minutes and is measured to be 53 pg/mL. The Cmax in the aqueous humor is attained within 2 hours after administration. and has been estimated to be 15-30 ng/mL.


Route of Elimination

After hepatic beta-oxidation, the metabolites of latanoprost are primarily found to be excreted by the kidneys. About 88% of the latanoprost dose is recovered in the urine after topical administration. About 15% of a dose is reported to be excreted in the feces.


Volume of Distribution

The volume of distribution of latanoprost is 0.16 0.02 L/kg. The activated acid form of latanoprost can be measured in aqueous humor in the initial 4 hours post-administration, and it is measured in the plasma only for 1 hour following ophthalmic administration. This drug is more lipophilic than its parent prostaglandin and easily penetrates the cornea. It has been shown to cross the placenta in rats.


Clearance

The systemic clearance of latanoprost is 7 mL/min/kg.


5.6 Metabolism/Metabolites

After corneal uptake, this prodrug is hydrolyzed and activated by esterases to become a pharmacologically active drug. The small portion of this drug that is able to reach the circulation is found to be metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites through fatty acid beta-oxidation.


5.7 Biological Half-Life

The elimination half-life of latanoprost from the plasma is about 17 minutes. The elimination half-life of latanoprost from the eye is estimated at 23 hours.


5.8 Mechanism of Action

Elevated intraocular pressure leads to an increased risk of glaucomatous visual field loss. The higher the intraocular pressure, the higher the risk of damage to the optic nerve and loss of visual field. Latanoprost selectively stimulates the prostaglandin F2 alpha receptor and this results in a decreased intraocular pressure (IOP) via the increased outflow of aqueous humor, which is often implicated in cases of elevated intraocular pressure. Possible specific mechanisms of the abovementioned increased aqueous outflow are the remodeling of the extracellular matrix and regulation of matrix metalloproteinases. These actions result in higher tissue permeability related to humor outflow pathways, which likely change outflow resistance and/or outflow rates.


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Cayman Pharma s.r.o

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Chirogate International

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Century Pharmaceuticals

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Gentec Pharmaceutical Group

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Capital Farma

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API Reference Price

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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715193000,"product":"LATANOPROST RELATED COMPOUND E(QTY:6 X 0.025 G, VALUE: USD 40.47\/EACH) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.15","actualQuantity":"0.00015","unit":"KGS","unitRateFc":"1618800","totalValueFC":"250","currency":"USD","unitRateINR":"138943066.7","date":"09-May-2024","totalValueINR":"20841.46","totalValueInUsd":"250","indian_port":"Hyderabad Air","hs_no":"29375000","bill_no":"3408232","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. 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12-Jan-2021
30-Dec-2024
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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.005%

USFDA APPLICATION NUMBER - 20597

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DOSAGE - EMULSION;OPHTHALMIC - 0.005%

USFDA APPLICATION NUMBER - 206185

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ABOUT THIS PAGE

Looking for 130209-82-4 / Latanoprost API manufacturers, exporters & distributors?

Latanoprost manufacturers, exporters & distributors 1

11

PharmaCompass offers a list of Latanoprost 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 Latanoprost manufacturer or Latanoprost supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Latanoprost manufacturer or Latanoprost supplier.

PharmaCompass also assists you with knowing the Latanoprost API Price utilized in the formulation of products. Latanoprost API Price is not always fixed or binding as the Latanoprost Price is obtained through a variety of data sources. The Latanoprost Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Latanoprost

Synonyms

130209-82-4, Xalatan, Phxa41, Phxa-41, Xa41, Phxa 41

Cas Number

130209-82-4

Unique Ingredient Identifier (UNII)

8S5FB3XXG8

About Latanoprost

A prostaglandin F analog used to treat OCULAR HYPERTENSION in patients with GLAUCOMA.

GAAP Ofteno Manufacturers

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

GAAP Ofteno Suppliers

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

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

GAAP Ofteno USDMF

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

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

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

GAAP Ofteno JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The GAAP Ofteno Drug Master File in Japan (GAAP Ofteno JDMF) empowers GAAP Ofteno API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the GAAP Ofteno JDMF during the approval evaluation for pharmaceutical products. At the time of GAAP Ofteno JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of GAAP Ofteno suppliers with JDMF on PharmaCompass.

GAAP Ofteno KDMF

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

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

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

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

GAAP Ofteno CEP

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

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

GAAP Ofteno WC

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

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

GAAP Ofteno 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 GAAP Ofteno as an active pharmaceutical ingredient (API).

Finished drug products

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

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

GAAP Ofteno GMP

GAAP Ofteno 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 GAAP Ofteno 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 GAAP Ofteno GMP manufacturer or GAAP Ofteno GMP API supplier for your needs.

GAAP Ofteno CoA

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

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

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