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1. 1-methylethyl (5z)-7-((1r,2r, 3r,5s)-2-((1e)-3,3-difluoro-4-phenoxy -1-butenyl)-3,5-dihydroxycyclopentyl)-5-heptenoate
2. Afp-168
1. 209860-87-7
2. Afp-168
3. Taflotan
4. Zioptan
5. Saflutan
6. Mk-2452
7. 1o6wq6t7g3
8. Chebi:66899
9. Mk2452
10. (z)-isopropyl 7-((1r,2r,3r,5s)-2-((e)-3,3-difluoro-4-phenoxybut-1-en-1-yl)-3,5-dihydroxycyclopentyl)hept-5-enoate
11. Tapros
12. Isopropyl (5z)-7-{(1r,2r,3r,5s)-2-[(1e)-3,3-difluoro-4-phenoxybut-1-en-1-yl]-3,5-dihydroxycyclopentyl}hept-5-enoate
13. Propan-2-yl (5z)-7-[(1r,2r,3r,5s)-2-[(1e)-3,3-difluoro-4-phenoxybut-1-en-1-yl]-3,5-dihydroxycyclopentyl]hept-5-enoate
14. Propan-2-yl (z)-7-[(1r,2r,3r,5s)-2-[(e)-3,3-difluoro-4-phenoxybut-1-enyl]-3,5-dihydroxycyclopentyl]hept-5-enoate
15. Zioptan (tn)
16. Isopropyl (5z)-7-((1r,2r,3r,5s)-2-((1e)-3,3-difluoro-4-phenoxybut-1-enyl)-3,5-dihydroxycyclopentyl)hept-5-enoate
17. Isopropyl (5z)-7-{(1r,2r,3r,5s)-2-((1e)-3,3-difluoro-4-phenoxybut-1-enyl)-3,5-dihydroxycyclopentyl}hept-5-enoate
18. Tafluprost [inn]
19. Tafluprost [mi]
20. Tafluprost [jan]
21. Tafluprost [inci]
22. Tafluprost [usan]
23. Tafluprost [vandf]
24. Tafluprost [mart.]
25. Tafluprost [who-dd]
26. Unii-1o6wq6t7g3
27. Tafluprost (jan/usan/inn)
28. Tafluprost [usan:inn:ban]
29. Gtpl7451
30. Schembl1286148
31. Chembl1963683
32. Tafluprost [orange Book]
33. Ex-a564
34. Dtxsid401021504
35. Hms3649f04
36. Mk2452afp-168
37. Hy-b0600
38. De-085
39. De-118
40. S4851
41. Zinc13912394
42. Akos025294885
43. Ccg-269257
44. Db08819
45. As-75193
46. D06274
47. 860t877
48. Sr-01000946707
49. J-502635
50. Q2139543
51. Sr-01000946707-1
52. (z)-isopropyl 7-((1r,2r,3r,5s)-2-((e)-3,3-difluoro-4-phenoxybut-1-en-1-yl)-3,5-dihydroxy Cyclopentyl)hept-5-enoate
53. (z)-isopropyl7-((1r,2r,3r,5s)-2-((e)-3,3-difluoro-4-phenoxybut-1-en-1-yl)-3,5-dihydroxycyclopentyl)hept-5-enoate
54. 1-methylethyl (5-z)-7-[(1r,2r,3r,5s)-2-[(1e)-3,3-difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl]-5-heptenoate
55. 1-methylethyl (5z)-7-((1r,2r, 3r,5s)-2-((1e)-3,3-difluoro-4-phenoxy -1-butenyl-3,5-dihydroxycyclopentyl)-5-heptenoate
56. 1-methylethyl (5z)-7-{(1r,2r,3r,5s)-2-((1e)-3,3-difluoro-4-phenoxybut-1-enyl)-3,5- Dihydroxycyclopentyl}hept-5-enoate
57. 5-heptenoic Acid, 7-((1r,2r,3r,5s)-2-((1e)-3,3-difluoro-4-phenoxy-1-buten-1-yl)-3,5- Dihydroxycyclopentyl)-, 1-methylethyl Ester, (5z)-
58. 5-heptenoic Acid, 7-[(1r,2r,3r,5s)-2-[(1e)-3,3-difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl]-, 1-methylethyl Ester, (5z)-
59. 5-heptenoic Acid, 7-[(1r,2r,3r,5s)-2-[(1e)-3,3-difluoro-4-phenoxy-1-butenyl]-3,5-dihydroxycyclopentyl]-, 1-methylethyl Ester, (5z)-
60. Propan-2-yl (z)-7-[(1r,2r,3r,5s)-2-[(e)-3,3-difluoro-4-(phenoxy)but-1-enyl]-3,5-dihydroxycyclopentyl]hept-5-enoate
Molecular Weight | 452.5 g/mol |
---|---|
Molecular Formula | C25H34F2O5 |
XLogP3 | 4.5 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 13 |
Exact Mass | 452.23743050 g/mol |
Monoisotopic Mass | 452.23743050 g/mol |
Topological Polar Surface Area | 76 Ų |
Heavy Atom Count | 32 |
Formal Charge | 0 |
Complexity | 614 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 2 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Zioptan |
PubMed Health | Tafluprost (Into the eye) |
Drug Classes | Antiglaucoma |
Drug Label | Tafluprost is a fluorinated analog of prostaglandin F2. The chemical name for tafluprost is 1-methylethyl (5Z)-7-{(1R, 2R, 3R, 5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-butenyl}-3,5-dihydroxycyclopentyl]-5-heptenoate. The molecular formula of tafluprost... |
Active Ingredient | Tafluprost |
Dosage Form | Solution/drops |
Route | Ophthalmic |
Strength | 0.0015% |
Market Status | Prescription |
Company | Oak Pharms |
2 of 2 | |
---|---|
Drug Name | Zioptan |
PubMed Health | Tafluprost (Into the eye) |
Drug Classes | Antiglaucoma |
Drug Label | Tafluprost is a fluorinated analog of prostaglandin F2. The chemical name for tafluprost is 1-methylethyl (5Z)-7-{(1R, 2R, 3R, 5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-butenyl}-3,5-dihydroxycyclopentyl]-5-heptenoate. The molecular formula of tafluprost... |
Active Ingredient | Tafluprost |
Dosage Form | Solution/drops |
Route | Ophthalmic |
Strength | 0.0015% |
Market Status | Prescription |
Company | Oak Pharms |
Tafluprost is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
FDA Label
Treatment of glaucoma
Tafluprost is a novel prostaglandin analog with a high affinity for the fluoroprostaglandin (FP) receptor PGF2. Tafluprost has an affinity for the FP receptor that is approximately 12 times higher than that of the carboxylic acid of latanoprost, but with almost no potential to bind to other receptors.
S - Sensory organs
S01 - Ophthalmologicals
S01E - Antiglaucoma preparations and miotics
S01EE - Prostaglandin analogues
S01EE05 - Tafluprost
Absorption
Following instillation, tafluprost is absorbed through the cornea and is hydrolyzed to the biologically active acid metabolite, tafluprost acid. Tafluprost is an ester which makes the drug lipophillic enough to be quickly absorbed through. When administered to the eye, the peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax) of tafluprost acid in healthy subjects was 26 pg/mL and 10 minutes respectively. a AUC, tafluprost acid = 394 pg*min/mL - 432 pg*min/mL.
Route of Elimination
Mean plasma tafluprost acid concentrations were below the limit of quantification of the bioanalytical assay (10 pg/mL) at 30 minutes following topical ocular administration of tafluprost 0.0015% ophthalmic solution. In male rats, it was observed that tafluprost was excreted into the feces.
Volume of Distribution
The highest concentration of tafluprost acid was found in the cornea and conjunctiva.
Tafluprost is an ester prodrug which is rapidly hydrolyzed by corneal esterases to form its biologically active acid metabolite. Tafluprost acid is further metabolized via fatty acid -oxidation and phase II conjugation into 1,2,3,4-tetranor acid.
Tafluprost acid is a prostanoid selective FP receptor agonist that is believed to reduce the intraocular pressure (IOP) by increasing the outflow of aqueous humor. Studies in animals and humans suggest that the main mechanism of action is increased uveoscleral outflow.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-15
Pay. Date : 2021-04-06
DMF Number : 35765
Submission : 2021-04-12
Status : Active
Type : II
Available Reg Filing : RU |
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-04-02
Pay. Date : 2025-02-14
DMF Number : 33632
Submission : 2019-04-11
Status : Active
Type : II
Registration Number : 303MF10019
Registrant's Address : No. 2, Shih 4th Rd. , Yangmei Dist. , Taoyuan City 326013, Taiwan
Initial Date of Registration : 2021-01-26
Latest Date of Registration :
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-01-20
Registration Number : Su434-27-ND
Manufacturer Name : Chirogate International Inc. Youth Plant
Manufacturer Address : No.2, Shih 4th Rd., Yangmei Dist., Taoyuan City 326013, Taiwan
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-11-23
Pay. Date : 2015-08-24
DMF Number : 29564
Submission : 2015-07-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39505
Submission : 2024-02-06
Status : Active
Type : II
NDC Package Code : 76397-013
Start Marketing Date : 2020-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
STN1011101, a preservative-free combination eye drop of tafluprost 0.0015% and timolol 0.5%. It is being developed for lowering intraocular pressure of patients with open-angle glaucoma or ocular hypertension.
Lead Product(s): Tafluprost,Timolol Maleate
Therapeutic Area: Ophthalmology Brand Name: Taptiqom
Study Phase: Approved FDFProduct Type: HPAPI
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 08, 2023
Lead Product(s) : Tafluprost,Timolol Maleate
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : STN1011101, a preservative-free combination eye drop of tafluprost 0.0015% and timolol 0.5%. It is being developed for lowering intraocular pressure of patients with open-angle glaucoma or ocular hypertension.
Product Name : Taptiqom
Product Type : HPAPI
Upfront Cash : Inapplicable
February 08, 2023
Details:
Tafluprost Ophthalmic Solution 0.0015% is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Lead Product(s): Tafluprost,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Tafluprost-Generic
Study Phase: Approved FDFProduct Type: HPAPI
Sponsor: Thea Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 18, 2022
Lead Product(s) : Tafluprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Thea Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Prasco Launches Authorized Generic of ZIOPTAN® Ophthalmic Solution (30408 DU)
Details : Tafluprost Ophthalmic Solution 0.0015% is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Product Name : Tafluprost-Generic
Product Type : HPAPI
Upfront Cash : Inapplicable
November 18, 2022
Details:
Under the deal, Théa Pharma acquired seven products including established glaucoma therapies Zioptan®, Cosopt®, Cosopt® PF, and Betimol®, along with Azasite®, Akten®, and the ocular surface repair agent AcellFX™.
Lead Product(s): Tafluprost,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Zioptan
Study Phase: Approved FDFProduct Type: HPAPI
Sponsor: Théa Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition March 09, 2022
Lead Product(s) : Tafluprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Théa Pharma
Deal Size : Undisclosed
Deal Type : Acquisition
Akorn Announces Completion of the Sale of its Branded Ophthalmic Products to Théa Pharma (15331 D...
Details : Under the deal, Théa Pharma acquired seven products including established glaucoma therapies Zioptan®, Cosopt®, Cosopt® PF, and Betimol®, along with Azasite®, Akten®, and the ocular surface repair agent AcellFX™.
Product Name : Zioptan
Product Type : HPAPI
Upfront Cash : Undisclosed
March 09, 2022
Details:
The purchase will add seven established brands, including Akorn’s leading glaucoma therapy, Zioptan®, to Théa’s portfolio. Théa will also welcome Akorn’s nearly 50-person sales force, which Théa expects to expand in support of anticipated growth and launches of additional products in the U.S.
Lead Product(s): Tafluprost,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Zioptan
Study Phase: Approved FDFProduct Type: HPAPI
Sponsor: Laboratoires Thea
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 28, 2022
Lead Product(s) : Tafluprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Laboratoires Thea
Deal Size : Undisclosed
Deal Type : Acquisition
Théa to Acquire Branded Ophthalmic Products from Akorn, Expanding Théa’s Presence into the U.S...
Details : The purchase will add seven established brands, including Akorn’s leading glaucoma therapy, Zioptan®, to Théa’s portfolio. Théa will also welcome Akorn’s nearly 50-person sales force, which Théa expects to expand in support of anticipated growt...
Product Name : Zioptan
Product Type : HPAPI
Upfront Cash : Undisclosed
January 28, 2022
Details:
Taflotan (tafluprost) is the first preservative-free prostaglandin F2α analogue approved for the treatment open-angle glaucoma and in the management of ocular hypertension.
Lead Product(s): Tafluprost,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Taptiqom
Study Phase: Approved FDFProduct Type: HPAPI
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 20, 2021
Lead Product(s) : Tafluprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Santen Confirms Taflotan’S Efficacy in Reducing Intraocular Pressure, Inhibiting Glaucoma (36072...
Details : Taflotan (tafluprost) is the first preservative-free prostaglandin F2α analogue approved for the treatment open-angle glaucoma and in the management of ocular hypertension.
Product Name : Taptiqom
Product Type : HPAPI
Upfront Cash : Inapplicable
July 20, 2021
Details:
Latanoprost is a HPAPI drug candidate, which is currently being evaluated in clinical studies for the treatment of Glaucoma, Open-Angle.
Lead Product(s): Latanoprost,Tafluprost
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: HPAPI
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 04, 2021
Lead Product(s) : Latanoprost,Tafluprost
Therapeutic Area : Ophthalmology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Latanoprost is a HPAPI drug candidate, which is currently being evaluated in clinical studies for the treatment of Glaucoma, Open-Angle.
Product Name : Undisclosed
Product Type : HPAPI
Upfront Cash : Inapplicable
February 04, 2021
Details:
Taptiqom (tafluprost/timolol) is a PTGFR agonist which is being developed for statistical and clinically significant intraocular pressure (IOP) reductions in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).
Lead Product(s): Tafluprost,Timolol Maleate
Therapeutic Area: Ophthalmology Brand Name: Taptiqom
Study Phase: Approved FDFProduct Type: HPAPI
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2020
Lead Product(s) : Tafluprost,Timolol Maleate
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Santen EMEA Announces RWD on Taptiqom (40467 DU)
Details : Taptiqom (tafluprost/timolol) is a PTGFR agonist which is being developed for statistical and clinically significant intraocular pressure (IOP) reductions in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).
Product Name : Taptiqom
Product Type : HPAPI
Upfront Cash : Inapplicable
February 26, 2020
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PharmaCompass offers a list of Tafluprost 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 Tafluprost manufacturer or Tafluprost supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tafluprost manufacturer or Tafluprost supplier.
PharmaCompass also assists you with knowing the Tafluprost API Price utilized in the formulation of products. Tafluprost API Price is not always fixed or binding as the Tafluprost Price is obtained through a variety of data sources. The Tafluprost Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tafluprost manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tafluprost, including repackagers and relabelers. The FDA regulates Tafluprost manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tafluprost 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 Tafluprost manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tafluprost supplier is an individual or a company that provides Tafluprost active pharmaceutical ingredient (API) or Tafluprost finished formulations upon request. The Tafluprost suppliers may include Tafluprost API manufacturers, exporters, distributors and traders.
click here to find a list of Tafluprost suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tafluprost DMF (Drug Master File) is a document detailing the whole manufacturing process of Tafluprost active pharmaceutical ingredient (API) in detail. Different forms of Tafluprost DMFs exist exist since differing nations have different regulations, such as Tafluprost USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tafluprost DMF submitted to regulatory agencies in the US is known as a USDMF. Tafluprost USDMF includes data on Tafluprost's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tafluprost USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tafluprost suppliers with USDMF on PharmaCompass.
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 Tafluprost Drug Master File in Japan (Tafluprost JDMF) empowers Tafluprost 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 Tafluprost JDMF during the approval evaluation for pharmaceutical products. At the time of Tafluprost 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 Tafluprost suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Tafluprost Drug Master File in Korea (Tafluprost KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tafluprost. The MFDS reviews the Tafluprost KDMF as part of the drug registration process and uses the information provided in the Tafluprost KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tafluprost 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 Tafluprost API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tafluprost suppliers with KDMF on PharmaCompass.
A Tafluprost written confirmation (Tafluprost WC) is an official document issued by a regulatory agency to a Tafluprost manufacturer, verifying that the manufacturing facility of a Tafluprost active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tafluprost APIs or Tafluprost finished pharmaceutical products to another nation, regulatory agencies frequently require a Tafluprost WC (written confirmation) as part of the regulatory process.
click here to find a list of Tafluprost 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 Tafluprost as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tafluprost 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 Tafluprost 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 Tafluprost and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tafluprost NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tafluprost suppliers with NDC on PharmaCompass.
Tafluprost 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 Tafluprost 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 Tafluprost GMP manufacturer or Tafluprost GMP API supplier for your needs.
A Tafluprost CoA (Certificate of Analysis) is a formal document that attests to Tafluprost's compliance with Tafluprost specifications and serves as a tool for batch-level quality control.
Tafluprost CoA mostly includes findings from lab analyses of a specific batch. For each Tafluprost 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.
Tafluprost may be tested according to a variety of international standards, such as European Pharmacopoeia (Tafluprost EP), Tafluprost JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tafluprost USP).