Synopsis
Synopsis
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CEP/COS
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
Molecular Weight | 539.6 g/mol |
---|---|
Molecular Formula | C31H33N5O4 |
XLogP3 | 3.3 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 8 |
Exact Mass | 539.25325455 g/mol |
Monoisotopic Mass | 539.25325455 g/mol |
Topological Polar Surface Area | 94.2 A^2 |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 947 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Ofev |
Drug Label | OFEV capsules contain nintedanib, a kinase inhibitor [see Mechanism of Action (12.1)]. Nintedanib is presented as the ethanesulfonate salt (esylate), with the chemical name 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazin... |
Active Ingredient | Nintedanib |
Dosage Form | Capsule |
Route | Oral |
Strength | 150mg; 100mg |
Market Status | Prescription |
Company | Boehringer Ingelheim |
2 of 2 | |
---|---|
Drug Name | Ofev |
Drug Label | OFEV capsules contain nintedanib, a kinase inhibitor [see Mechanism of Action (12.1)]. Nintedanib is presented as the ethanesulfonate salt (esylate), with the chemical name 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazin... |
Active Ingredient | Nintedanib |
Dosage Form | Capsule |
Route | Oral |
Strength | 150mg; 100mg |
Market Status | Prescription |
Company | Boehringer Ingelheim |
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-26
Pay. Date : 2018-12-20
DMF Number : 33361
Submission : 2019-01-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-27
Pay. Date : 2018-03-30
DMF Number : 32511
Submission : 2018-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-05
Pay. Date : 2019-10-10
DMF Number : 32152
Submission : 2017-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-06-05
Pay. Date : 2018-03-19
DMF Number : 32504
Submission : 2018-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-09
Pay. Date : 2018-04-24
DMF Number : 32643
Submission : 2018-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32408
Submission : 2018-01-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-24
Pay. Date : 2019-12-02
DMF Number : 34332
Submission : 2019-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-03
Pay. Date : 2018-09-20
DMF Number : 33152
Submission : 2018-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-05
Pay. Date : 2018-03-07
DMF Number : 31526
Submission : 2017-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32529
Submission : 2018-02-22
Status : Active
Type : II
Date of Issue : 2023-11-28
Valid Till : 2026-11-28
Written Confirmation Number : WC-0310
Address of the Firm : Plot No. Z-103/l, Dahej SEZ, Phase II, Dahej, Dist-Bharuch, Gujarat, India
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-0340
Address of the Firm : R.S No: 578, Near Effluent Channel, at & Post: Luna, Taluka: Padra, District: Va...
Date of Issue : 2022-09-30
Valid Till : 2025-04-14
Written Confirmation Number : WC-340n
Address of the Firm : RS No: 578, Near Effluent Channel, at & Post: Luna, Taluka: Padra, District: Vad...
Date of Issue : 2022-06-20
Valid Till : 2025-08-08
Written Confirmation Number : WC-0113
Address of the Firm : Old Madras Road, Virgo Nagar Post, Bengaluru - 560 049
Date of Issue : 2022-07-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm : Unit-I, Sy. No. 10, I.D.A, Gaddapotharam (V), Jinnaram (M), Sangareddy District,...
Date of Issue : 2022-07-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm : Unit-I, Sy. No. 10, I.D.A, Gaddapotharam (V), Jinnaram (M), Sangareddy District,...
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm : Unit-II, Sy. No. 50, Kardanur (Village), Patancheru (Mandai), Sangareddy Distric...
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm : Unit-II, Sy. No. 50, Kardanur (Village), Patancheru (Mandai), Sangareddy Distric...
Nintedanib esilate hemihydrate
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2024-11-01
Registration Number : 163-37-ND
Manufacturer Name : Fermion Oy, Hanko plant
Manufacturer Address : Orioninkatu 2, Hanko Pohjoinen, 10960, Finland
Nintedanib esilate hemihydrate
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2022-01-12
Registration Number : 163-23-ND
Manufacturer Name : Fermion Oy
Manufacturer Address : Lääketehtaantie 2, Oulu, FI-90660, Finland
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2023-09-26
Registration Number : Number 812-21-ND
Manufacturer Name : Alivus Life Sciences Limited
Manufacturer Address : Plot No.Z-103/ I, DAHEJ SEZ Phase II, City : Dahej, District : Bharuch, Gujarat State...
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2022-11-24
Registration Number : Thu15-12-ND
Manufacturer Name : Bidachem SpA
Manufacturer Address : Strada Statale 11 (Padana Superiore), 8, 24040 Fornovo San Giovanni (BG), ITALY
Nintedanib esilate hemihydrate
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-06-02
Registration Number : Su289-33-ND
Manufacturer Name : Chongqing Huapont Shengchem ...
Manufacturer Address : No. 666 Rongjun Road, Nanjin Avenue Hechuan District, Chongqing China
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-09-04
Registration Number : Su258-22-ND
Manufacturer Name : Hetero Labs Limited Unit-I
Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...
Nintedanib esilate (micronized)
Registrant Name : Inistesti Co., Ltd.
Registration Date : 2023-07-10
Registration Number : 2220-16-ND
Manufacturer Name : Inistesti Co., Ltd.
Manufacturer Address : 500 Shinnae-ro, Geumwang-eup, Eumseong-gun, Chungcheongbuk-do
Nintedanib esilate (micronized)
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-01-13
Registration Number : Number 173-33-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...
Registrant Name : Sampoong Pharmachem Co., Ltd.
Registration Date : 2025-01-07
Registration Number : No. 582-17-ND
Manufacturer Name : Shandong Anhong Pharmaceutic...
Manufacturer Address : No. 29 Huayuan Street Linyi County, Dezhou, Shandong, China
Nintedanib esilate hemihydrate
Registrant Name : Innovent
Registration Date : 2025-01-13
Registration Number : No. 6206-1-ND
Manufacturer Name : Sichuan Kelun Pharmaceutical...
Manufacturer Address : No. 3 of Yangzong 6th Road, Yang'an Industrial Park, Qionglai, Chengdu, Sichuan PR Ch...
NDC Package Code : 76361-0003
Start Marketing Date : 2024-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51869-0040
Start Marketing Date : 2014-10-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 12714-133
Start Marketing Date : 2014-10-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66499-0061
Start Marketing Date : 2018-04-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66529-0015
Start Marketing Date : 2019-12-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 82758-505
Start Marketing Date : 2022-05-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54893-0059
Start Marketing Date : 2017-03-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0093
Start Marketing Date : 2020-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0092
Start Marketing Date : 2020-05-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63592-7200
Start Marketing Date : 2016-07-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
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Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
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Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
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RLD :
TE Code :
Brand Name : NINTEDANIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date :
Application Number : 212732
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : NINTEDANIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date :
Application Number : 212732
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : NINTEDANIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date :
Application Number : 215123
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : OFEV
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2014-10-15
Application Number : 205832
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OFEV
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2014-10-15
Application Number : 205832
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : NINTEDANIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date :
Application Number : 212555
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : NINTEDANIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : 100MG
Approval Date :
Application Number : 216915
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : NINTEDANIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG
Approval Date :
Application Number : 216915
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info :
Registration Country : Sweden
Brand Name : Ofev
Dosage Form : SOFT CAPSULE
Dosage Strength : 150 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Ofev
Dosage Form : SOFT CAPSULE
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Vargatef
Dosage Form : KAPSEL, MJUK
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Ofev
Dosage Form : Nintedanib 100Mg 60 Units Oral Use
Dosage Strength : 1x60 soft cps 100 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Ofev
Dosage Form : Capsule, soft
Dosage Strength : 100 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Ofev
Dosage Form : Capsule, soft
Dosage Strength : 150 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Vargatef
Dosage Form : Capsule, soft
Dosage Strength : 100 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Vargatef
Dosage Form : Capsule, soft
Dosage Strength : 100 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ofev
Dosage Form : Caps
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ofev
Dosage Form : Caps
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Global Sales Information
Company :
Nintedanib Esylate
Drug Cost (USD) : 1,762,963,783
Year : 2022
Prescribers : 20686
Prescriptions : 143756
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Nintedanib Esylate
Drug Cost (USD) : 1,495,198,249
Year : 2021
Prescribers : 19476
Prescriptions : 129070
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Nintedanib Esylate
Drug Cost (USD) : 1,157,563,828
Year : 2020
Prescribers : 15902
Prescriptions : 105327
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Nintedanib Esylate
Drug Cost (USD) : 789,557,042
Year : 2019
Prescribers : 11971
Prescriptions : 77644
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Nintedanib Esylate
Drug Cost (USD) : 618,635,442
Year : 2018
Prescribers : 9834
Prescriptions : 66458
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Nintedanib Esylate
Drug Cost (USD) : 494,127,312
Year : 2017
Prescribers : 8645
Prescriptions : 56153
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Nintedanib Esylate
Drug Cost (USD) : 371,895,203
Year : 2016
Prescribers : 7231
Prescriptions : 43840
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Nintedanib Esylate
Drug Cost (USD) : 198,860,646
Year : 2015
Prescribers : 5283
Prescriptions : 24594
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
NINTEDANIB ESYLATE
Drug Cost (USD) : 5,939,246
Year : 2014
Prescribers : 539
Prescriptions : 732
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Market Place
Patents & EXCLUSIVITIES
Patent Expiration Date : 2026-07-08
US Patent Number : 10154990*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 205832
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-07-08
Patent Expiration Date : 2026-04-01
US Patent Number : 6762180*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 205832
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-04-01
Patent Expiration Date : 2026-04-01
US Patent Number : 6762180*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 205832
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-04-01
Patent Expiration Date : 2029-06-07
US Patent Number : 9907756
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205832
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-06-07
Patent Expiration Date : 2025-10-01
US Patent Number : 6762180
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 205832
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-10-01
Patent Expiration Date : 2025-10-01
US Patent Number : 6762180
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 205832
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-10-01
Patent Expiration Date : 2029-12-07
US Patent Number : 9907756*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 205832
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-07
Patent Expiration Date : 2026-07-08
US Patent Number : 10154990*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 205832
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-07-08
Patent Expiration Date : 2026-01-08
US Patent Number : 10154990
Drug Substance Claim :
Drug Product Claim :
Application Number : 205832
Patent Use Code : U-2620
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-01-08
Patent Expiration Date : 2029-06-04
US Patent Number : 10105323
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205832
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-06-04
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
60
PharmaCompass offers a list of Nintedanib Esylate 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 Nintedanib Esylate manufacturer or Nintedanib Esylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nintedanib Esylate manufacturer or Nintedanib Esylate supplier.
PharmaCompass also assists you with knowing the Nintedanib Esylate API Price utilized in the formulation of products. Nintedanib Esylate API Price is not always fixed or binding as the Nintedanib Esylate Price is obtained through a variety of data sources. The Nintedanib Esylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nintedanib Esylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nintedanib Esylate, including repackagers and relabelers. The FDA regulates Nintedanib Esylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nintedanib Esylate 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 Nintedanib Esylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nintedanib Esylate supplier is an individual or a company that provides Nintedanib Esylate active pharmaceutical ingredient (API) or Nintedanib Esylate finished formulations upon request. The Nintedanib Esylate suppliers may include Nintedanib Esylate API manufacturers, exporters, distributors and traders.
click here to find a list of Nintedanib Esylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nintedanib Esylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Nintedanib Esylate active pharmaceutical ingredient (API) in detail. Different forms of Nintedanib Esylate DMFs exist exist since differing nations have different regulations, such as Nintedanib Esylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nintedanib Esylate DMF submitted to regulatory agencies in the US is known as a USDMF. Nintedanib Esylate USDMF includes data on Nintedanib Esylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nintedanib Esylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nintedanib Esylate suppliers with USDMF 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 Nintedanib Esylate Drug Master File in Korea (Nintedanib Esylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nintedanib Esylate. The MFDS reviews the Nintedanib Esylate KDMF as part of the drug registration process and uses the information provided in the Nintedanib Esylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nintedanib Esylate 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 Nintedanib Esylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nintedanib Esylate suppliers with KDMF on PharmaCompass.
A Nintedanib Esylate written confirmation (Nintedanib Esylate WC) is an official document issued by a regulatory agency to a Nintedanib Esylate manufacturer, verifying that the manufacturing facility of a Nintedanib Esylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nintedanib Esylate APIs or Nintedanib Esylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Nintedanib Esylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Nintedanib Esylate 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 Nintedanib Esylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nintedanib Esylate 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 Nintedanib Esylate 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 Nintedanib Esylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nintedanib Esylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nintedanib Esylate suppliers with NDC on PharmaCompass.
Nintedanib Esylate 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 Nintedanib Esylate 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 Nintedanib Esylate GMP manufacturer or Nintedanib Esylate GMP API supplier for your needs.
A Nintedanib Esylate CoA (Certificate of Analysis) is a formal document that attests to Nintedanib Esylate's compliance with Nintedanib Esylate specifications and serves as a tool for batch-level quality control.
Nintedanib Esylate CoA mostly includes findings from lab analyses of a specific batch. For each Nintedanib Esylate 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.
Nintedanib Esylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Nintedanib Esylate EP), Nintedanib Esylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nintedanib Esylate USP).