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1. (e,3r,5s)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic Acid
2. Itavastatin
3. Itavastatin Calcium
4. Nisvastatin
5. Nk 104
6. Nk-104
7. P 872441
8. P-872441
9. Pitavastatin
10. Pitavastatin Calcium
11. Pitavastatin Lactone
1. Pitavastatin Calcium
2. 147526-32-7
3. Livalo
4. Nisvastatin
5. Nk-104
6. Itavastatin Calcium
7. Pitavastatin Calcium Salt
8. Calcium (3r,5s,e)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate
9. Nk 104
10. Iyd54xeg3w
11. Chebi:71258
12. Calcium;(e,3r,5s)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate
13. P-872441
14. Pitavastatin Calcium (jan)
15. Pitavastatin Calcium [jan]
16. Alipza
17. Flovas
18. Livazo
19. Unii-iyd54xeg3w
20. Nk 104 (acid)
21. Redevant
22. Ccris 8652
23. Livalo (tn)
24. Schembl22720
25. Bis((3r,5s,6e)-7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoate), Monocalcium Salt
26. Chembl1237061
27. Dtxsid4046448
28. Chebi:94569
29. Pitavastatin Hemicalcium;nk-104
30. Nks-104
31. Act02718
32. Mfcd01937979
33. Pitavastatin Calcium [mart.]
34. Pitavastatin Calcium [who-dd]
35. Akos015900407
36. Pitavastatin Calcium Salt [mi]
37. Am84441
38. Ks-1220
39. (+)-monocalciumbis{(3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-hepten
40. 111ge002
41. 6-heptenoic Acid, 7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl)-3,5-dihydroxy-, Calcium Salt (2:1), (s-(r*,s*-(e)))-
42. Pitavastatin Calcium [orange Book]
43. D01862
44. Q-201590
45. Q27139472
46. (+)-monocalciumbis[(3r,5s,6e)-7-[2-cyclopropyl-4(4-fluorophenyl)-3-quinolyl]3,5-dihydroxy-6-hepteno Ate]
47. (3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic Acid Hemicalcium Salt
48. Bis((3r,5s,6e)-7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoate) Monocalcium Salt
49. Calcium (3r,5s,e)-7-(2-cyclopropyl-4-(4-fluorophenyl)-quinolin-3-yl)-3,5-dihydroxyhept-6-enoate
50. Calcium Bis{(3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate}
| Molecular Weight | 881.0 g/mol |
|---|---|
| Molecular Formula | C50H46CaF2N2O8 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 14 |
| Exact Mass | 880.2848136 g/mol |
| Monoisotopic Mass | 880.2848136 g/mol |
| Topological Polar Surface Area | 187 Ų |
| Heavy Atom Count | 63 |
| Formal Charge | 0 |
| Complexity | 626 |
| 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 | 3 |
| 1 of 2 | |
|---|---|
| Drug Name | Livalo |
| PubMed Health | Pitavastatin (By mouth) |
| Drug Classes | Antihyperlipidemic |
| Active Ingredient | Pitavastatin calcium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 4mg base; eq 2mg base; eq 1mg base |
| Market Status | Prescription |
| Company | Kowa |
| 2 of 2 | |
|---|---|
| Drug Name | Livalo |
| PubMed Health | Pitavastatin (By mouth) |
| Drug Classes | Antihyperlipidemic |
| Active Ingredient | Pitavastatin calcium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 4mg base; eq 2mg base; eq 1mg base |
| Market Status | Prescription |
| Company | Kowa |
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. (See all compounds classified as Hydroxymethylglutaryl-CoA Reductase Inhibitors.)
API SUPPLIERS
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Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-22
Pay. Date : 2013-07-30
DMF Number : 25956
Submission : 2012-04-11
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
Registrant Name : Hanyoung Farm Co., Ltd.
Registration Date : 2022-07-18
Registration Number : No. 2816-6-ND(3)
Manufacturer Name : Solara Active Pharma Sciences Limited
Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33489
Submission : 2019-05-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-16
Pay. Date : 2018-01-25
DMF Number : 32169
Submission : 2018-01-17
Status : Active
Type : II
Registration Number : 302MF10150
Registrant's Address : 110, MAGOKDONG-RO, GANGSEO-GU, SEOUL, KOREA
Initial Date of Registration : 2020-12-15
Latest Date of Registration : --
Registrant Name : Kolon Life Science Co., Ltd.
Registration Date : 2020-01-13
Registration Number : 1607-1-ND
Manufacturer Name : Kolon Life Science Co., Ltd.
Manufacturer Address : 54, Gipyodosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32345
Submission : 2017-12-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14660
Submission : 2000-01-11
Status : Active
Type : II
Registration Number : 223MF10122
Registrant's Address : 2-5-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-07-28
Latest Date of Registration : --
NDC Package Code : 44343-001
Start Marketing Date : 2009-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : JDW Pharmaceutical Co., Ltd.
Registration Date : 2004-09-14
Registration Number : Su269-2-ND
Manufacturer Name : Onoda Plant, Nissan Chemical Corporation
Manufacturer Address : 6903-1, Oaza Onoda, Sanyo Onoda, Yamaguchi 756-0093 Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27761
Submission : 2013-12-10
Status : Active
Type : II
Registration Number : 217MF10137
Registrant's Address : 2-5-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-24
Latest Date of Registration : --
NDC Package Code : 44343-001
Start Marketing Date : 2009-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : JDW Pharmaceutical Co., Ltd.
Registration Date : 2004-09-14
Registration Number : Su269-2-ND
Manufacturer Name : Onoda Plant, Nissan Chemical Corporation
Manufacturer Address : 6903-1, Oaza Onoda, Sanyo Onoda, Yamaguchi 756-0093 Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15303
Submission : 2001-02-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28384
Submission : 2014-06-13
Status : Inactive
Type : II
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-14
Pay. Date : 2013-05-07
DMF Number : 27106
Submission : 2013-05-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-10
DMF Number : 27255
Submission : 2013-07-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15303
Submission : 2001-02-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-07-08
DMF Number : 27242
Submission : 2013-07-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-17
Pay. Date : 2013-03-28
DMF Number : 23488
Submission : 2010-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14660
Submission : 2000-01-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-30
DMF Number : 25956
Submission : 2012-04-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-19
Pay. Date : 2013-06-18
DMF Number : 27144
Submission : 2013-06-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26406
Submission : 2012-12-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-29
DMF Number : 27333
Submission : 2013-07-31
Status : Active
Type : II
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Japanese Pharmacopoeia Pitavastatin Calcium Hydrate
Registration Number : 303MF10052
Registrant's Address : Yamagata Prefecture Higashine City Higashine City 5850-1
Initial Date of Registration : 2021-03-26
Latest Date of Registration : 2021-03-26
Registration Number : 229MF10194
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2017-11-07
Latest Date of Registration : 2017-11-07
Registration Number : 225MF10204
Registrant's Address : 13, KOLON-RO, GWACHEON-SI, GYEONGGI-DO, KOREA
Initial Date of Registration : 2013-11-11
Latest Date of Registration : 2013-11-11
Registration Number : 302MF10150
Registrant's Address : 110, MAGOKDONG-RO, GANGSEO-GU, SEOUL, KOREA
Initial Date of Registration : 2020-12-15
Latest Date of Registration : 2020-12-15
Pitavastatin calcium hydrate "KBP"
Registration Number : 304MF10079
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2022-05-25
Latest Date of Registration : 2022-05-25
Registration Number : 223MF10122
Registrant's Address : 2-5-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-07-28
Latest Date of Registration : 2015-05-25
Pitavastatin calcium hydrate M
Registration Number : 304MF10026
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2022-02-02
Latest Date of Registration : 2022-02-02
Registration Number : 224MF10148
Registrant's Address : 2nd Floor, Admin Block 27, Vandalooor kelambakkam Road, Keelakottaiyur Village, Melak...
Initial Date of Registration : 2012-07-31
Latest Date of Registration : 2023-10-12
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Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy.No.1/22, 2/1 To 5, 6 to 18, 61 to 69, Pydibhimavaram Village, Ranasthalam, Sr...
Date of Issue : 2022-12-16
Valid Till : 2025-12-15
Written Confirmation Number : WC-0544
Address of the Firm : Plot No. 825,826,827, Industrial Area, Sector-Ill, Pithampur,\\r\\nDhar-454774, ...
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm : Plot No. 1, Hetero SEZ Infrastructure Ltd., Narasapuram, Visakhapatnam-531 081, ...
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm : Sy. Nos: 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Man...
Date of Issue : 2022-05-10
Valid Till : 2025-07-25
Written Confirmation Number : WC-0027A2
Address of the Firm : Unit-II, Survey No.14, IDA Gaddapotharam (Village), Kazipally, Jinnaram (Mandal)...
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore-607 005
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0084
Address of the Firm : Plot No 26, 29 & 31, Umraya Road, Village Dabhasa, Tal -Padra- 381 440, Vadodara...
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Registrant Name : Boryeong Co., Ltd.
Registration Date : 2019-04-10
Registration Number : 1689-5-ND
Manufacturer Name : Boryeong Co., Ltd.
Manufacturer Address : 107, 109 Neungan-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Registrant Name : Kolon Life Science Co., Ltd.
Registration Date : 2020-01-13
Registration Number : 1607-1-ND
Manufacturer Name : Kolon Life Science Co., Ltd.
Manufacturer Address : 54, Gipyodosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 2152-12-ND
Manufacturer Name : Korea Biochem Pharmaceutical...
Manufacturer Address : 204 Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2021-12-01
Registration Number : 1673-49-ND
Manufacturer Name : Kyungbo Pharmaceutical Co., ...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2020-01-30
Registration Number : 1574-8-ND
Manufacturer Name : Kyungdong Pharmaceutical Co....
Manufacturer Address : 15, Balan Industrial Complex Road 2-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : MFC Corporation
Registration Date : 2017-01-09
Registration Number : 346-1-ND
Manufacturer Name : MFC Corporation
Manufacturer Address : 35 Cheongwon Industrial Complex 7-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do
Registrant Name : Hanyoung Farm Co., Ltd.
Registration Date : 2022-07-18
Registration Number : No. 2816-6-ND(3)
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...
Registrant Name : Chodang Pharmaceutical Industry Co., Ltd.
Registration Date : 2020-01-13
Registration Number : No. 2816-6-ND(1)
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2016-07-13
Registration Number : No. 2816-6-ND
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...
Registrant Name : Pharmasolution Co., Ltd.
Registration Date : 2021-03-18
Registration Number : No. 2816-6-ND(A)
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...
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ABOUT THIS PAGE
A Redevant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Redevant, including repackagers and relabelers. The FDA regulates Redevant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Redevant 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 Redevant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Redevant supplier is an individual or a company that provides Redevant active pharmaceutical ingredient (API) or Redevant finished formulations upon request. The Redevant suppliers may include Redevant API manufacturers, exporters, distributors and traders.
click here to find a list of Redevant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Redevant DMF (Drug Master File) is a document detailing the whole manufacturing process of Redevant active pharmaceutical ingredient (API) in detail. Different forms of Redevant DMFs exist exist since differing nations have different regulations, such as Redevant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Redevant DMF submitted to regulatory agencies in the US is known as a USDMF. Redevant USDMF includes data on Redevant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Redevant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Redevant 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 Redevant Drug Master File in Japan (Redevant JDMF) empowers Redevant 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 Redevant JDMF during the approval evaluation for pharmaceutical products. At the time of Redevant 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 Redevant 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 Redevant Drug Master File in Korea (Redevant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Redevant. The MFDS reviews the Redevant KDMF as part of the drug registration process and uses the information provided in the Redevant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Redevant 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 Redevant API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Redevant suppliers with KDMF on PharmaCompass.
A Redevant written confirmation (Redevant WC) is an official document issued by a regulatory agency to a Redevant manufacturer, verifying that the manufacturing facility of a Redevant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Redevant APIs or Redevant finished pharmaceutical products to another nation, regulatory agencies frequently require a Redevant WC (written confirmation) as part of the regulatory process.
click here to find a list of Redevant 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 Redevant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Redevant 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 Redevant 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 Redevant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Redevant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Redevant suppliers with NDC on PharmaCompass.
Redevant 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 Redevant 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 Redevant GMP manufacturer or Redevant GMP API supplier for your needs.
A Redevant CoA (Certificate of Analysis) is a formal document that attests to Redevant's compliance with Redevant specifications and serves as a tool for batch-level quality control.
Redevant CoA mostly includes findings from lab analyses of a specific batch. For each Redevant 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.
Redevant may be tested according to a variety of international standards, such as European Pharmacopoeia (Redevant EP), Redevant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Redevant USP).
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