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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 20 USDMF, 5 EU WC, 3 KDMF, 13 NDC API, 29 Listed Suppliers, $ API Reference Price

44 API Suppliers
20 USDMF
5 EU WC
3 KDMF
13 NDC API
29 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

INTERMEDIATES

18 Intermediates Suppliers

18 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

35 FDF Dossiers, 8 FDA Orange Book, 15 Europe, 2 Canada, 4 Australia, 2 South Africa, 4 Listed Dossiers

35 FDF Dossiers
8 FDA Orange Book
15 Europe
2 Canada
4 Australia
2 South Africa
4 Listed Dossiers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 69 NEWS #PharmaBuzz

media
3 DATA COMPILATION #PharmaFlow
69 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 9 Finished Drug Prices, 4 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
9 Finished Drug Prices
4 Annual Reports

MARKET PLACE

4 APIs, 6 FDF Dossiers

marketPlace
4 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 4 US Exclusivities

patents
18 US Patents
4 US Exclusivities

REF. STANDARDS & IMPURITIES

1 Others

otherSolutions
1 Others

Fermion Nintedanib Esylate

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

1,762,963,783

Annual Reports (USD Million)

12,424

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown

Click the button for full data set

Also known as:

Molecular Formula

C₃₁H₃₃N₅O₄

Molecular Weight

539.6 g/mol

InChI Key

XZXHXSATPCNXJR-ZIADKAODSA-N

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 Formula	C₃₁H₃₃N₅O₄
Molecular Weight	539.6 g/mol
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

4 Drug and Medication Information

4.1 Drug Information

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

API SUPPLIERS

01

Fermion Oy

Finland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof India

Not Confirmed

With Fermion, start the journey of your innovative API.

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Finland

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Digital Content

USDMF

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CEP/COS JDMF EU-WC NDC KDMF

VMF ASMF

AUDIT

02

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof India

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Midas Pharma

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof India

Not Confirmed

Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

Contact Supplier

Germany

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

04

Veranova

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof India

Not Confirmed

Veranova: A CDMO that manages complexity with confidence.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

05

Inabata France S.A.S

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof India

Not Confirmed

IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

Contact Supplier

France

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

06

Hubei Gedian Humanwell Pharmaceuti...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof India

Not Confirmed

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

Contact Supplier

China

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

07

Jinan Tantu Chemicals

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI China

Exhibiting

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

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China

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

08

Omgene Life Sciences Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof India

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

09

Sichuan Kelun Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof India

Not Confirmed

10

Glenmark Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof India

Not Confirmed

Only 10 entries up to this point, click to access all

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USDMF

01

Fermion Oy

Finland

CPHI Middle east

Not Confirmed

With Fermion, start the journey of your innovative API.

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Finland

Virtual Booth

Digital Content

Nintedanib Esylate

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

02

Veranova Lp

U.S.A

CPHI Middle east

Not Confirmed

Veranova: A CDMO that manages complexity with confidence.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Nintedanib Esylate

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

03

Hubei Humanwell Chengtian Pharmaceut...

China

CPHI Middle east

Not Confirmed

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

Contact Supplier

China

Virtual Booth

Digital Content

Nintedanib Esylate

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

04

05

06

07

08

Jiangsu Hansoh Pharmaceutical Group ...

China

CPHI Middle east

Not Confirmed

09

10

Olon Spa

Italy

CPHI Middle east

Not Confirmed

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EU WC

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KDMF

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NDC API

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Listed Suppliers

01

Fermion Oy

Finland

Cosmoprof India

Not Confirmed

With Fermion, start the journey of your innovative API.

Contact Supplier

Finland

Virtual Booth

Digital Content

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.

02

Metrochem API Private Limited

India

Cosmoprof India

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

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 ...

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

03

Midas Pharma

Germany

Cosmoprof India

Not Confirmed

Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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Germany

Virtual Booth

Digital Content

Nintedanib Esylate

About the Company : Midas Pharma is a pharmaceutical company that excels in providing extensive expertise while fostering connections between companies, individuals, and knowledge. The core competence...

Midas Pharma is a pharmaceutical company that excels in providing extensive expertise while fostering connections between companies, individuals, and knowledge. The core competence of Midas Pharma lies in project management related to pharmaceutical supply chains. The company is actively involved in sourcing, supplying, and developing Active Pharmaceutical Ingredients (API) and Finished Dosage Forms (FDF) manufactured by its contract manufacturing partners. For each project or product, Midas Pharma selects the most suitable match from its network of manufacturing partners.

04

Veranova

U.S.A

Cosmoprof India

Not Confirmed

Veranova: A CDMO that manages complexity with confidence.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

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.

05

Inabata France S.A.S

France

Cosmoprof India

Not Confirmed

IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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France

Virtual Booth

Digital Content

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.

06

Hubei Gedian Humanwell Pharmaceutic...

China

Cosmoprof India

Not Confirmed

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

Contact Supplier

China

Virtual Booth

Digital Content

Nintedanib Esylate

About the Company : Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is a modern high-tech pharmaceutical company with a focus on the research and development, production, and sales of fertility regula...

Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is a modern high-tech pharmaceutical company with a focus on the research and development, production, and sales of fertility regulation drugs and steroidal APIs. It operates as a wholly-owned subsidiary of Humanwell Healthcare Group (Stock Code: 600079), one of the leading pharmaceutical conglomerates in China. The company operates two APIs manufacturing sites, one formulation factory, and one excipients factory, showcasing its commitment to integrating the reproductive health industry chain from raw materials and active pharmaceutical ingredients (APIs) to finished dosage forms.

07

Jinan Tantu Chemicals

China

CPhI China

Exhibiting

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

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China

Virtual Booth

Digital Content

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.

08

Omgene Life Sciences Pvt. Ltd

India

Cosmoprof India

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

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.

09

Cipla

India

Cosmoprof India

Not Confirmed

10

Formosa Laboratories

Taiwan

Cosmoprof India

Not Confirmed

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API Reference Price

[{"dataSource":"API Export","activeIngredients":"NINTEDANIB ESYLATE","year":"2021","qtr":"Q1","strtotime":1610389800,"product":"NINTEDANIB ESYLATE (GROUP:B) (TAX INVOIC E NO:1905205230 DT:05.01.2021","address":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR","city":"HYDERABAD, A.P.","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"OSAKA","customer":"TOWA PHARMACEUTICAL","customerCountry":"JAPAN","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"16.6","totalValueFC":"1678.7","currency":"USD","unitRateINR":1227.73,"date":"12-Jan-2021","totalValueINR":"122773","totalValueInUsd":"1678.7","indian_port":"HYDERABAD AIR","hs_no":"29337990","bill_no":"7868504","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q1","strtotime":1611081000,"product":"NINTEDANIB (BASE) (BATCH NO: ZV0020120)","address":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR","city":"HYDERABAD, A.P.","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"DISPERSOL TECHNOLOGIES LLC","customerCountry":"UNITED STATES","quantity":"0.40","actualQuantity":"0.4","unit":"KGS","unitRateFc":"14567.3","totalValueFC":"5899.7","currency":"USD","unitRateINR":1078710,"date":"20-Jan-2021","totalValueINR":"431484","totalValueInUsd":"5899.7","indian_port":"HYDERABAD AIR","hs_no":"29337990","bill_no":"8025769","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"NINTEDANIB ESYLATE","year":"2021","qtr":"Q1","strtotime":1614623400,"product":"NINTEDANIB ESYLATE (GROUP:B) (TAX INVOIC E NO:1905205283 DT:22.02.2021","address":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR","city":"HYDERABAD, A.P.","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"OSAKA","customer":"TOWA PHARMACEUTICAL","customerCountry":"JAPAN","quantity":"2.90","actualQuantity":"2.9","unit":"KGS","unitRateFc":"14923.1","totalValueFC":"42830.2","currency":"USD","unitRateINR":1075206.8965517241,"date":"02-Mar-2021","totalValueINR":"3118100","totalValueInUsd":"42830.2","indian_port":"HYDERABAD AIR","hs_no":"29337990","bill_no":"9039929","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"NINTEDANIB ESYLATE","year":"2021","qtr":"Q1","strtotime":1616005800,"product":"NINTEDANIB ESYLATE (GROUP:B) (TAX INVOIC E NO:1905205310 DT:15.03.2021","address":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR","city":"HYDERABAD, A.P.","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"SEOUL","customer":"DAEWOONG PHARMACEUTICAL","customerCountry":"KOREA, REPUBLIC OF","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"9801.7","totalValueFC":"4850.3","currency":"USD","unitRateINR":706212,"date":"18-Mar-2021","totalValueINR":"353106","totalValueInUsd":"4850.3","indian_port":"HYDERABAD AIR","hs_no":"29337990","bill_no":"9457612","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1625077800,"product":"NINTEDANIB ESYLATE (TAX INVOICE NO:19052 15104 DT:28-06-2021","address":"8-3-167\/D\/16, KALYAN NAGAR - 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