List of Japan Drug Master File (JDMF) for Formoterol Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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Also known as: Mls001401438, Chembl1895091, Hms2051p14, Hms2233m10, Ccg-101038, Nc00288
Molecular Formula
C23H30N2O9
Molecular Weight
478.5  g/mol
InChI Key
AXAGNMKWGBWLMO-GQMFVQBYSA-N

Formoterol Fumarate
1 2D Structure

Formoterol Fumarate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid;N-[2-hydroxy-5-[(1S)-1-hydroxy-2-[[(2S)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide;hydrate
2.1.2 InChI
InChI=1S/C19H24N2O4.C4H4O4.H2O/c1-13(9-14-3-6-16(25-2)7-4-14)20-11-19(24)15-5-8-18(23)17(10-15)21-12-22;5-3(6)1-2-4(7)8;/h3-8,10,12-13,19-20,23-24H,9,11H2,1-2H3,(H,21,22);1-2H,(H,5,6)(H,7,8);1H2/b;2-1+;/t13-,19+;;/m0../s1
2.1.3 InChI Key
AXAGNMKWGBWLMO-GQMFVQBYSA-N
2.1.4 Canonical SMILES
CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C(C=C2)O)NC=O)O.C(=CC(=O)O)C(=O)O.O
2.1.5 Isomeric SMILES
C[C@@H](CC1=CC=C(C=C1)OC)NC[C@H](C2=CC(=C(C=C2)O)NC=O)O.C(=C/C(=O)O)\C(=O)O.O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Mls001401438

2. Chembl1895091

3. Hms2051p14

4. Hms2233m10

5. Ccg-101038

6. Nc00288

7. Smr000471620

2.3 Create Date
2007-12-08
3 Chemical and Physical Properties
Molecular Weight 478.5 g/mol
Molecular Formula C23H30N2O9
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count10
Rotatable Bond Count10
Exact Mass478.19513054 g/mol
Monoisotopic Mass478.19513054 g/mol
Topological Polar Surface Area166 Ų
Heavy Atom Count34
Formal Charge0
Complexity507
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3

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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670351400,"product":"FORMOTEROL FUMARATE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"219","totalValueFC":"2179.2","currency":"USD","unitRateINR":"17958","date":"07-Dec-2022","totalValueINR":"179580","totalValueInUsd":"2179.2","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29242990","bill_no":"1005071","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671129000,"product":"FORMOTEROL FUMARATE (FORMOTEROL FUMARATE USP), BATCH NO P-82M","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.12","actualQuantity":"0.12","unit":"KGS","unitRateFc":"160000","totalValueFC":"20899.4","currency":"EUR","unitRateINR":"14352000","date":"16-Dec-2022","totalValueINR":"1722240","totalValueInUsd":"20899.4","indian_port":"DELHI AIR","hs_no":"29349990","bill_no":"3775553","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671993000,"product":"FORMOTEROL FUMARATE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"2.50","actualQuantity":"2500","unit":"GMS","unitRateFc":"185.4","totalValueFC":"469964","currency":"USD","unitRateINR":"15491.2","date":"26-Dec-2022","totalValueINR":"38727975","totalValueInUsd":"469964","indian_port":"Indore-EPZ\/SEZ","hs_no":"29420090","bill_no":"1008562","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675362600,"product":"FORMOTEROL FUMARATE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"191587.4","totalValueFC":"191958.5","currency":"USD","unitRateINR":"15853860","date":"03-Feb-2023","totalValueINR":"15853860","totalValueInUsd":"191958.5","indian_port":"Indore-EPZ\/SEZ","hs_no":"29420090","bill_no":"1000748","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGAT ARGENT 1 08755 CASTELLBISBAL BARCELONA, SPAIN","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677695400,"product":"FORMOTEROL FUMARATE (QTY-0.10 KGS X 165000 EUR\/PER KGS)","address":"PLOT NO.2, MAITHRIVIHAR AMEERPET,","city":"HYDERABAD","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"165000","totalValueFC":"18104.8","currency":"EUR","unitRateINR":"14891250","date":"02-Mar-2023","totalValueINR":"1489125","totalValueInUsd":"18104.8","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"4876496","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITHRIVIHAR AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694111400,"product":"FORMOTEROL FUMARATE DIHYDRATE API","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"XXNEAXXIREXXND XXD","supplierCountry":"IRELAND","foreign_port":"A BAIUCA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"219","totalValueFC":"2211.5","currency":"USD","unitRateINR":"18385.1","date":"08-Sep-2023","totalValueINR":"183851","totalValueInUsd":"2211.5","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29242970","bill_no":"1003724","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"A BAIUCA","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699295400,"product":"FORMOTEROL FUMARATE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"135000","totalValueFC":"136800.1","currency":"USD","unitRateINR":"11360250","date":"07-Nov-2023","totalValueINR":"11360250","totalValueInUsd":"136800.1","indian_port":"Indore-EPZ\/SEZ","hs_no":"29242990","bill_no":"1007301","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGATC\/ARGENT 1 08755 CASTELLBISBA BARCELONA, SPAIN SPAIN","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700677800,"product":"FORMOTEROL FUMARATE DIHYDRATE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"AMNEAL PHARMACEUTICALS","supplierCountry":"IRELAND","foreign_port":"DUBLIN","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"219","totalValueFC":"2217.9","currency":"USD","unitRateINR":"18417.9","date":"23-Nov-2023","totalValueINR":"184179","totalValueInUsd":"2217.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29242990","bill_no":"1004738","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBLIN","supplierAddress":"CAHIR ROAD,CASHEL, CO TIPPERARY,E25XD51, , IRELAND","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702578600,"product":"FORMOTEROL FUMARATE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"135068.9","totalValueFC":"137113.9","currency":"USD","unitRateINR":"11386304","date":"15-Dec-2023","totalValueINR":"11386304","totalValueInUsd":"137113.9","indian_port":"Indore-EPZ\/SEZ","hs_no":"29242970","bill_no":"1008145","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGATC\/ARGENT 1 08755 CASTELLBISBA BARCELONA, SPAIN SPAIN","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711737000,"product":"FORMOTEROL FUMARATE (QTY-0.034 KG)ASPER INV","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.034","unit":"KGS","unitRateFc":"165000","totalValueFC":"6248.9","currency":"EUR","unitRateINR":"15262500","date":"30-Mar-2024","totalValueINR":"518925","totalValueInUsd":"6248.9","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"2816129","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/ARGENT 1, AREA INDUSTRIAL DEL LLOBREGAT 08755 CASTELLBISBAL BARCELONA,SPAIN Spain","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714588200,"product":"FORMOTEROL FUMARATE","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"CHEMO","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"200000","totalValueFC":"4065.4","currency":"USD","unitRateINR":"16880000","date":"02-May-2024","totalValueINR":"337600","totalValueInUsd":"4065.4","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"3306636","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO,28,3RD FLOOR 28050 MADRID SPAIN Madrid, , SpainSDNF Spain","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715193000,"product":"FORMOTEROL FUMARATE (IUPAC NAME:N-(2-HYDROXY-5-(1-HYDROXY-2-((1-(4-METHOXYPHENYL)PROPAN-2-YL)AMINO)ETHYL)PHENYL)FORMAMID","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"135000","totalValueFC":"137125.3","currency":"USD","unitRateINR":"11387250","date":"09-May-2024","totalValueINR":"11387250","totalValueInUsd":"137125.3","indian_port":"Indore-EPZ\/SEZ","hs_no":"29420090","bill_no":"1003275","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715625000,"product":"NOT MICRONIZED FORMOTEROL FUMARATE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"60","unit":"GMS","unitRateFc":"110","totalValueFC":"6703.9","currency":"USD","unitRateINR":"9278.5","date":"14-May-2024","totalValueINR":"556710","totalValueInUsd":"6703.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29242970","bill_no":"1001749","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717525800,"product":"FORMOTEROL FUMARATE (BATCH NO.P-126M) (15 GMS) FORMOTEROL FUMARATE DIHYDRATE","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.015","unit":"KGS","unitRateFc":"176000","totalValueFC":"2940.7","currency":"EUR","unitRateINR":"16280000","date":"05-Jun-2024","totalValueINR":"244200","totalValueInUsd":"2940.7","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"3844348","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LIOBREGAT C\/ARGENT, 1 08755 CASTELBISBAL BARCELONASPAIN Barcelona, , Spain Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717612200,"product":"FORMOTEROL FUMARATE (IUPAC NAME:N-(2-HYDROXY-5-(1-HYDROXY-2-((1-(4-METHOXYPHENYL)PROPAN-2-YL)AMINO)ETHYL)PHENYL)FORMAMID","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"135000","totalValueFC":"274250.5","currency":"USD","unitRateINR":"11387250","date":"06-Jun-2024","totalValueINR":"22774500","totalValueInUsd":"274250.5","indian_port":"Indore-EPZ\/SEZ","hs_no":"29420090","bill_no":"1004048","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718044200,"product":"FORMOTEROL FUMARATE (IUPAC NAME N-(2-HYDROXY-5-(1-HYDROXY-2-((1-(4-METHOXYPHENYL)PROPAN-2-YL)AMINO)ETHYL)PHENYL)FORMAMID","address":"159, C.S.T. 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ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"135000","totalValueFC":"274900.8","currency":"USD","unitRateINR":"11414250","date":"29-Jul-2024","totalValueINR":"22828500","totalValueInUsd":"274900.8","indian_port":"Indore-EPZ\/SEZ","hs_no":"29420090","bill_no":"1005513","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"}]
21-Jan-2021
23-Aug-2024
KGS
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DOSAGE - POWDER;INHALATION - 0.012MG/INH **Fe...DOSAGE - POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20831

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USFDA APPLICATION NUMBER - 21929

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USFDA APPLICATION NUMBER - 21929

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DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH

USFDA APPLICATION NUMBER - 22518

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Formoterol Manufacturers | Traders | Suppliers

Formoterol Manufacturers, Traders, Suppliers 1
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