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Synopsis

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Chemistry

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Also known as:
Molecular Formula
C31H33N5O4
Molecular Weight
539.6  g/mol
InChI Key
XZXHXSATPCNXJR-ZIADKAODSA-N

Nintedanib Esylate
1 2D Structure

Nintedanib Esylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
methyl (3Z)-3-[[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]anilino]-phenylmethylidene]-2-oxo-1H-indole-6-carboxylate
2.1.2 InChI
InChI=1S/C31H33N5O4/c1-34-15-17-36(18-16-34)20-27(37)35(2)24-12-10-23(11-13-24)32-29(21-7-5-4-6-8-21)28-25-14-9-22(31(39)40-3)19-26(25)33-30(28)38/h4-14,19,32H,15-18,20H2,1-3H3,(H,33,38)/b29-28-
2.1.3 InChI Key
XZXHXSATPCNXJR-ZIADKAODSA-N
2.1.4 Canonical SMILES
CN1CCN(CC1)CC(=O)N(C)C2=CC=C(C=C2)NC(=C3C4=C(C=C(C=C4)C(=O)OC)NC3=O)C5=CC=CC=C5
2.1.5 Isomeric SMILES
CN1CCN(CC1)CC(=O)N(C)C2=CC=C(C=C2)N/C(=C\3/C4=C(C=C(C=C4)C(=O)OC)NC3=O)/C5=CC=CC=C5
2.2 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 539.6 g/mol
Molecular Formula C31H33N5O4
XLogP33.3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count8
Exact Mass539.25325455 g/mol
Monoisotopic Mass539.25325455 g/mol
Topological Polar Surface Area94.2 A^2
Heavy Atom Count40
Formal Charge0
Complexity947
Isotope Atom Count0
Defined Atom Stereocenter Count0
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 2  
Drug NameOfev
Drug LabelOFEV 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 IngredientNintedanib
Dosage FormCapsule
RouteOral
Strength150mg; 100mg
Market StatusPrescription
CompanyBoehringer Ingelheim

2 of 2  
Drug NameOfev
Drug LabelOFEV 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 IngredientNintedanib
Dosage FormCapsule
RouteOral
Strength150mg; 100mg
Market StatusPrescription
CompanyBoehringer Ingelheim

USDMF

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Fermion Oy

Finland
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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

fermion

02

Veranova Lp

U.S.A
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Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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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

Veranova

03

Discovery Europe
Not Confirmed

03

Discovery Europe
Not Confirmed

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

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Cipla Ltd

India

USDMF

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Not Confirmed

04

Cipla Ltd

India
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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

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05

Discovery Europe
Not Confirmed

06

Discovery Europe
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07

Discovery Europe
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Discovery Europe
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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

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08

Discovery Europe
Not Confirmed

09

Discovery Europe
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09

Discovery Europe
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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

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Olon Spa

Italy

USDMF

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EU WC

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Discovery Europe
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Nintedanib Esylate IH

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

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02

Discovery Europe
Not Confirmed
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Nintedanib Esylate IH

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...

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Discovery Europe
Not Confirmed
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Nintedanib Esylate IH

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...

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04

Cipla

India
Discovery Europe
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Cipla

India
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Nintedanib Esylate IH

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

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Hetero Drugs

India
Discovery Europe
Not Confirmed
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Hetero Drugs

India
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Nintedanib Esylate IH

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,...

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Hetero Drugs

India
Discovery Europe
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Hetero Drugs

India
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Nintedanib Esylate IH

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,...

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Discovery Europe
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Nintedanib IH

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...

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Discovery Europe
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Nintedanib Esylate IH

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...

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KDMF

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01

Fermion Oy

Finland
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Virtual BoothWith Fermion, start the journey of your innovative API.

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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

fermion

02

Fermion Oy

Finland
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Virtual BoothWith Fermion, start the journey of your innovative API.

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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

fermion

03

Discovery Europe
Not Confirmed
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Nintedanib esilate

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...

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Bidachem

Italy
Discovery Europe
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Bidachem

Italy
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Nintedanib esilate

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

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Discovery Europe
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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

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Hetero Drugs

India
Discovery Europe
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Hetero Drugs

India
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Nintedanib esilate

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...

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07

Inist

South Korea
Discovery Europe
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Inist

South Korea
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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

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Discovery Europe
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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...

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Discovery Europe
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Nintedanib esilate

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

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Discovery Europe
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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...

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NDC API

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Discovery Europe
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NINTEDANIB ESYLATE

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

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Discovery Europe
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NINTEDANIB

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

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Discovery Europe
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NINTEDANIB ESYLATE

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

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Discovery Europe
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NINTEDANIB

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

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Discovery Europe
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NINTEDANIB ESYLATE

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

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Discovery Europe
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NINTEDANIB ESYLATE

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

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Discovery Europe
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NINTEDANIB ESYLATE

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

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Olon S.p.A.

Italy
Discovery Europe
Not Confirmed
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Olon S.p.A.

Italy
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NINTEDANIB

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

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Olon S.p.A.

Italy
Discovery Europe
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Olon S.p.A.

Italy
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NINTEDANIB

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

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Discovery Europe
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NINTEDANIB ESYLATE

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

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Listed Suppliers

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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Nintedanib Esylate

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Fermion Oy

Finland
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Virtual BoothWith Fermion, start the journey of your innovative API.

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Nintedanib Esylate

About the Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & F...

Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & Formulations. API portfolio consists of >30 generic APIs & >10 NCEs & 2 mfg. sites as well as R&D facilities are all located in Finland. Fermion has invested & expanded capabilities in the production of HPAPIs. Drug product CMO services include hormonal & non-hormonal semi-solids, cytotoxic oral solids & packaging. We have 3 mfg. sites & one packaging center for drug products at Orion.
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Veranova

U.S.A
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Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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Nintedanib Esylate

About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.
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Virtual BoothIKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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Nintedanib Esylate

About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...

Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata-Pharmasynthèse offers a wide range of services, including sourcing, manufacturing, and the development of raw materials for the pharmaceutical and cosmetic industries. It supplies these ingredients to Europe, Japan, and other countries. With expertise in fine chemical production, Inabata-Pharmasynthèse conducts manufacturing operations, ranging from pilot to commercial quantities, at its GMP-certified facility at St. Pierre-Les-Elbeuf in France.
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05

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Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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Nintedanib Esylate

About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...

Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.
Jinan Tantu Chemicals

06

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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Nintedanib

About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Nintedanib Esylate

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Nintedanib Esylate

About the Company : Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in mark...

Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India. The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South America and India. With 15 manufacturing facilities and 3 R&D centers dedicated to the goal of enriching lives across the globe.
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nintedanib

About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...

Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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Nintedanib Esylate

About the Company : Established in 2010, Mac-Chem is a NMM Group company. Mac-Chem is focused on oncology and other niche specialty APIs. It supplies quality APIs to the top 15 oncology players in Ind...

Established in 2010, Mac-Chem is a NMM Group company. Mac-Chem is focused on oncology and other niche specialty APIs. It supplies quality APIs to the top 15 oncology players in India. It is also the sole manufacturer of some of the molecules in the oncology segment and general segment. The company’s investments are mostly geared toward exports, especially to regulated markets. Mac-Chem has a cGMP-compliant manufacturing facility near Mumbai in India. The company’s facility is USFDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, WHO-GMP-approved and ISO-certified. Mac-Chem enjoys a global reach, serving more than 40 countries.
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API Reference Price

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C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"GULF AGENCY CO DUBAI LLC","customerCountry":"UNITED ARAB EMIRATES","quantity":"36.00","actualQuantity":"36","unit":"KGS","unitRateFc":"3465","totalValueFC":"123165.2","currency":"USD","unitRateINR":285604.36111111112,"date":"14-Jun-2024","totalValueINR":"10281757","totalValueInUsd":"123165.2","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"1676444","productDescription":"API","marketType":"","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718908200,"product":"NINTEDANIB ESYLATE BATCH NO - NN0091023","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"DEXCEL PHARMA TECHNOLOGIES LTD","customerCountry":"ISRAEL","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"5000","totalValueFC":"9894.7","currency":"USD","unitRateINR":413000,"date":"21-Jun-2024","totalValueINR":"826000","totalValueInUsd":"9894.7","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"1828723","productDescription":"API","marketType":"","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726857000,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32512200653 DT13.09.2024 NINTEDANIB ESYLATE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"UNDISCLOSED","customerCountry":"ARGENTINA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"4000","totalValueFC":"3844.2","currency":"USD","unitRateINR":322149.40000000002,"date":"21-Sep-2024","totalValueINR":"322149.4","totalValueInUsd":"3844.2","indian_port":"Dahez-SEZ","hs_no":"29349990","bill_no":"4217371","productDescription":"API","marketType":"","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732300200,"product":"NINTEDANIB ETHANESULFONATE BATCH NO;NESA22002P1","address":"N0 116\/117, KIADB INDUSTRIAL AREA,","city":"BANGALORE","supplier":"CDYMAX INDIA PHARMA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"WORLD MEDICINE ILAC SAN","customerCountry":"TURKEY","quantity":"1.48","actualQuantity":"1.48","unit":"KGS","unitRateFc":"2845","totalValueFC":"3837.5","currency":"USD","unitRateINR":218808.66216216216,"date":"23-Nov-2024","totalValueINR":"323836.82","totalValueInUsd":"3837.5","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"5851576","productDescription":"API","marketType":"","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"N0 116\/117, KIADB INDUSTRIAL AREA,, BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732645800,"product":"NINTEDANIB ESYLATE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"KUKJEON PHARMACEUTICAL COLTD","customerCountry":"KOREA, REPUBLIC OF","quantity":"19.00","actualQuantity":"19000","unit":"GMS","unitRateFc":"6.5","totalValueFC":"121941.4","currency":"USD","unitRateINR":541.6006315789474,"date":"27-Nov-2024","totalValueINR":"10290412","totalValueInUsd":"121941.4","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"5955846","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733941800,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32512201048 DT.11.12.2024 NINTEDANIB ESYLATE (GLS-D636)","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"NARITA APT\/TOKYO, 12","customer":"UNDISCLOSED","customerCountry":"JAPAN","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"7046.8","totalValueFC":"34790.7","currency":"USD","unitRateINR":591226.59999999998,"date":"12-Dec-2024","totalValueINR":"2956133","totalValueInUsd":"34790.7","indian_port":"Dahez-SEZ","hs_no":"29349990","bill_no":"6393861","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734460200,"product":"NINTEDANIB ESYLATE","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA LTD","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"KOLON PHARMACEUTICALS INC","customerCountry":"KOREA, REPUBLIC OF","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"6750","totalValueFC":"6665.1","currency":"USD","unitRateINR":566325,"date":"18-Dec-2024","totalValueINR":"566325","totalValueInUsd":"6665.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6559715","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736706600,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32512201198 DT.07.01.2025 NINTEDANIB ESYLATE(GLS-D636)","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"NARITA APT\/TOKYO","customer":"UNDISCLOSED","customerCountry":"JAPAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7125","totalValueFC":"6821.3","currency":"USD","unitRateINR":588196.54000000004,"date":"13-Jan-2025","totalValueINR":"588196.54","totalValueInUsd":"6821.3","indian_port":"Dahez-SEZ","hs_no":"29349990","bill_no":"7249749","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"NINTEDANIB ESYLATE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"KUKJEON PHARMACEUTICAL COLTD","customerCountry":"KOREA, REPUBLIC OF","quantity":"26.00","actualQuantity":"26000","unit":"GMS","unitRateFc":"6.5","totalValueFC":"166783.9","currency":"USD","unitRateINR":555.63161538461543,"date":"26-Mar-2025","totalValueINR":"14446422","totalValueInUsd":"166783.9","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"9359144","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743100200,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32512201532 DT.27.03.2025NINTEDANIB ESYLATE (GLS-D636)","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"ALIVUS LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"UNDISCLOSED","customerCountry":"ARGENTINA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"4000","totalValueFC":"3662.5","currency":"USD","unitRateINR":317233.59999999998,"date":"28-Mar-2025","totalValueINR":"317233.6","totalValueInUsd":"3662.5","indian_port":"Dahez-SEZ","hs_no":"29349990","bill_no":"9436554","productDescription":"API","marketType":"","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743532200,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32512201560 DT.28.03.2025 NINTEDANIB ESYLATE (GLS-D636)","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"ALIVUS LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"JOHN F. KENNEDY APT\/","customer":"UNDISCLOSED","customerCountry":"UNITED STATES","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2800","totalValueFC":"2509.4","currency":"USD","unitRateINR":214813.20000000001,"date":"02-Apr-2025","totalValueINR":"214813.2","totalValueInUsd":"2509.4","indian_port":"Dahez-SEZ","hs_no":"29349990","bill_no":"9618691","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746469800,"product":"NINTEDANIB ESYLATE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BIRMINGHAM","customer":"WESSEX FINE CHEMICALS","customerCountry":"UNITED KINGDOM","quantity":"1.10","actualQuantity":"1.1","unit":"KGS","unitRateFc":"20000","totalValueFC":"21628.9","currency":"USD","unitRateINR":1675268.1818181816,"date":"06-May-2025","totalValueINR":"1842795","totalValueInUsd":"21628.9","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"1561427","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746556200,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32612200107 DT.29.04.2025 NINTEDANIB ESYLATE (GLS-D636)","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"ALIVUS LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"NARITA APT\/TOKYO","customer":"UNDISCLOSED","customerCountry":"JAPAN","quantity":"36.18","actualQuantity":"36.18","unit":"KGS","unitRateFc":"5200","totalValueFC":"184920.3","currency":"USD","unitRateINR":435470.7338308458,"date":"07-May-2025","totalValueINR":"15755331.15","totalValueInUsd":"184920.3","indian_port":"Dahez-SEZ","hs_no":"29332990","bill_no":"1591870","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746642600,"product":"NINTEDANIB ESYLATE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"ASOFARMA S.A.I.Y C.","customerCountry":"ARGENTINA","quantity":"36.00","actualQuantity":"36","unit":"KGS","unitRateFc":"3213.5","totalValueFC":"113853.5","currency":"USD","unitRateINR":269455.32888888888,"date":"08-May-2025","totalValueINR":"9700391.84","totalValueInUsd":"113853.5","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"1625876","productDescription":"API","marketType":"","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747161000,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32612200173 DT.09.05.2025 NINTEDANIB ESYLATE (GLS-D636)","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"ALIVUS LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"NARITA APT\/TOKYO","customer":"UNDISCLOSED","customerCountry":"JAPAN","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"7125","totalValueFC":"20905.9","currency":"USD","unitRateINR":593732.06666666665,"date":"14-May-2025","totalValueINR":"1781196.2","totalValueInUsd":"20905.9","indian_port":"Dahez-SEZ","hs_no":"29332990","bill_no":"1777139","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747679400,"product":"PHARMACEUTICAL API NINTEDANIB ESYLATE","address":"5\/502, GARDEN ESTATE,","city":"THANE, MAHARASHTRA.","supplier":"AMTEC HEALTH CARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"DUESSELDORF","customer":"DEUTSCHTEC GMBH","customerCountry":"GERMANY","quantity":"22.00","actualQuantity":"22","unit":"KGS","unitRateFc":"2627","totalValueFC":"63079.3","currency":"EUR","unitRateINR":244290.60000000001,"date":"20-May-2025","totalValueINR":"5374393.2","totalValueInUsd":"63079.3","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"1990738","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"5\/502, GARDEN ESTATE,, THANE, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1661970600,"product":"NINTEDANIB ESYALTE - HY-11106 (1H-INDOLE-6-CARBOXYLIC ACID, 2,3-DIHYDRO-3-[[[4-[METHYL[2-(4-METHYL-1-PIPERAZINYL)ACETYL]","address":"28\/A, IDA, NACHARAM, Contact No: 919989112452","city":"HYDERABAD","supplier":"MEDCHEMEXPRESS LLC","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ARAGEN LIFE SCIENCES PRIVATE LTD","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"45","unit":"GMS","unitRateFc":"128.7","totalValueFC":"5819","currency":"USD","unitRateINR":"10363.1","date":"01-Sep-2022","totalValueINR":"466340.53","totalValueInUsd":"5819","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"2255154","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"28\/A, IDA, NACHARAM, Contact No: 919989112452"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706466600,"product":"NINTEDANIB ESYLATE (RE-IMP VIDE SB.NO:2942403 DT:03.08.2023)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"SAMA PHARM","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"MSN LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"14.00","actualQuantity":"14","unit":"KGS","unitRateFc":"8500","totalValueFC":"120415.1","currency":"USD","unitRateINR":"714850","date":"29-Jan-2024","totalValueINR":"10007900","totalValueInUsd":"120415.1","indian_port":"Hyderabad Air","hs_no":"29333929","bill_no":"9880894","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"49,DONGHWAGONGDAN-ROMUNMAK-EUP,WONNJU-SIGANGWON-DO,REPUBLIC OF KORA KR","customerAddress":"MSN HOUSE, PLOT NO. C-24,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728498600,"product":"NINTEDANIB ESYLATE (VIDE RE IMPORT SB NO: 2643464 DT:23.07.2024)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"VERBEN AG","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"MSN LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"3465","totalValueFC":"24768.2","currency":"USD","unitRateINR":"297312.8","date":"10-Oct-2024","totalValueINR":"2081189.66","totalValueInUsd":"24768.2","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"6055000","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBAI","supplierAddress":"LUGANO BRANCH, VIA F. PELLI 17, PO BOX 6901 LUGANO , LUGANO -6901,SWIT ZERLAND Switzerland","customerAddress":"MSN HOUSE, PLOT NO. C-24,"}]
11-Jan-2022
20-May-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

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API Imports and Exports

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

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FDA Orange Book

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01

ACCORD HLTHCARE INC

United Kingdom
Discovery Europe
Not Confirmed
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ACCORD HLTHCARE INC

United Kingdom
arrow
Discovery Europe
Not Confirmed

NINTEDANIB

Brand Name : NINTEDANIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date :

Application Number : 212732

RX/OTC/DISCN :

RLD :

TE Code :

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02

ACCORD HLTHCARE INC

United Kingdom
Discovery Europe
Not Confirmed
arrow

ACCORD HLTHCARE INC

United Kingdom
arrow
Discovery Europe
Not Confirmed

NINTEDANIB

Brand Name : NINTEDANIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date :

Application Number : 212732

RX/OTC/DISCN :

RLD :

TE Code :

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03

Discovery Europe
Not Confirmed
arrow
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Discovery Europe
Not Confirmed

NINTEDANIB

Brand Name : NINTEDANIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date :

Application Number : 215123

RX/OTC/DISCN :

RLD :

TE Code :

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04

Discovery Europe
Not Confirmed
arrow
arrow
Discovery Europe
Not Confirmed

NINTEDANIB ESYLATE

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 :

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05

Discovery Europe
Not Confirmed
arrow
arrow
Discovery Europe
Not Confirmed

NINTEDANIB ESYLATE

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 :

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06

Discovery Europe
Not Confirmed
arrow
arrow
Discovery Europe
Not Confirmed

NINTEDANIB ESYLATE

Brand Name : NINTEDANIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date :

Application Number : 212555

RX/OTC/DISCN :

RLD :

TE Code :

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07

Discovery Europe
Not Confirmed
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arrow
Discovery Europe
Not Confirmed

NINTEDANIB

Brand Name : NINTEDANIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date :

Application Number : 216915

RX/OTC/DISCN :

RLD :

TE Code :

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08

Discovery Europe
Not Confirmed
arrow
arrow
Discovery Europe
Not Confirmed

NINTEDANIB

Brand Name : NINTEDANIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date :

Application Number : 216915

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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01

Discovery Europe
Not Confirmed
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Discovery Europe
Not Confirmed

nintedanibesilat

Brand Name : Ofev

Dosage Form : SOFT CAPSULE

Dosage Strength : 150 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

Discovery Europe
Not Confirmed
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Discovery Europe
Not Confirmed

nintedanibesilat

Brand Name : Ofev

Dosage Form : SOFT CAPSULE

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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03

Discovery Europe
Not Confirmed
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Discovery Europe
Not Confirmed

nintedanibesilat

Brand Name : Vargatef

Dosage Form : KAPSEL, MJUK

Dosage Strength : 100 MG

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Registration Country : Sweden

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Vargatef

Brand Name : Ofev

Dosage Form : Nintedanib 100Mg 60 Units Oral Use

Dosage Strength : 1x60 soft cps 100 mg

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Registration Country : Italy

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Vargatef

Brand Name : Ofev

Dosage Form : Capsule, soft

Dosage Strength : 100 mg

Packaging : Blister

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Registration Country : Norway

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Vargatef

Brand Name : Ofev

Dosage Form : Capsule, soft

Dosage Strength : 150 mg

Packaging : Blister

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Regulatory Info :

Registration Country : Norway

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Vargatef

Brand Name : Vargatef

Dosage Form : Capsule, soft

Dosage Strength : 100 mg

Packaging : Blister

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Regulatory Info :

Registration Country : Norway

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Vargatef

Brand Name : Vargatef

Dosage Form : Capsule, soft

Dosage Strength : 100 mg

Packaging : Blister

Approval Date :

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Regulatory Info :

Registration Country : Norway

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Nintedanibum

Brand Name : Ofev

Dosage Form : Caps

Dosage Strength : 100mg

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Registration Country : Switzerland

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Nintedanibum

Brand Name : Ofev

Dosage Form : Caps

Dosage Strength : 150mg

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Registration Country : Switzerland

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Company :

Nintedanib Esylate

Drug Cost (USD) : 1,762,963,783

Year : 2022

Prescribers : 20686

Prescriptions : 143756

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Company :

Nintedanib Esylate

Drug Cost (USD) : 1,495,198,249

Year : 2021

Prescribers : 19476

Prescriptions : 129070

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Company :

Nintedanib Esylate

Drug Cost (USD) : 1,157,563,828

Year : 2020

Prescribers : 15902

Prescriptions : 105327

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Company :

Nintedanib Esylate

Drug Cost (USD) : 789,557,042

Year : 2019

Prescribers : 11971

Prescriptions : 77644

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Company :

Nintedanib Esylate

Drug Cost (USD) : 618,635,442

Year : 2018

Prescribers : 9834

Prescriptions : 66458

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Company :

Nintedanib Esylate

Drug Cost (USD) : 494,127,312

Year : 2017

Prescribers : 8645

Prescriptions : 56153

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Company :

Nintedanib Esylate

Drug Cost (USD) : 371,895,203

Year : 2016

Prescribers : 7231

Prescriptions : 43840

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Company :

Nintedanib Esylate

Drug Cost (USD) : 198,860,646

Year : 2015

Prescribers : 5283

Prescriptions : 24594

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Company :

NINTEDANIB ESYLATE

Drug Cost (USD) : 5,939,246

Year : 2014

Prescribers : 539

Prescriptions : 732

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US Patents

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NINTEDANIB ESYLATE

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

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NINTEDANIB ESYLATE

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

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NINTEDANIB ESYLATE

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

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NINTEDANIB ESYLATE

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

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NINTEDANIB ESYLATE

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

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NINTEDANIB ESYLATE

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

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NINTEDANIB ESYLATE

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

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NINTEDANIB ESYLATE

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

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NINTEDANIB ESYLATE

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

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NINTEDANIB ESYLATE

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

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Looking for / Nintedanib Esylate API manufacturers, exporters & distributors?

Nintedanib Esylate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Nintedanib Esylate

Nintedanib Esylate Manufacturers

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.

Nintedanib Esylate Suppliers

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.

Nintedanib Esylate USDMF

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.

Nintedanib Esylate KDMF

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.

Nintedanib Esylate WC

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.

Nintedanib Esylate 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 Nintedanib Esylate as an active pharmaceutical ingredient (API).

Finished drug products

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.

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 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.

Compounded drug products

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 GMP

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.

Nintedanib Esylate CoA

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).

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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