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01 2Acepromazine
02 1Afatinib
03 2Aldesleukin
04 3Alteplase
05 2Ambroxol Hydrochloride
06 1Ampicillin
07 1Atropine
08 1Atropine Sulfate
09 2Bisacodyl
10 2Bromhexine Hydrochloride
11 1Brotizolam
12 2Chloramphenicol Succinate Acid
13 1Chlorthalidone
14 2Clenbuterol Hydrochloride
15 1Clonidine
16 1Crotamiton
17 2Dabigatran Etexilate Mesylate
18 1Deruxtecan
19 2Dipyridamole
20 5Empagliflozin
21 1Epinastine Hydrochloride
22 1Etilefrine
23 1Fenoterol Hydrobromide
24 1Firocoxib
25 1Flibanserin
26 1Hyoscine Butyl Bromide
27 2Interferon Beta 1B
28 1Ipratropium Bromide
29 1Ketoprofen
30 4Linagliptin
31 1Magnesium
32 2Meloxicam
33 1Metaproterenol Hemisulfate
34 2Methocarbamol
35 1Nerandomilast
36 2Nintedanib Esylate
37 1Olodaterol Hydrochloride
38 1Penethamate Hydriodide
39 1Phenylephrine Hydrochloride
40 2Pramipexole Dihydrochloride
41 1Repaglinide
42 1Ribavirin
43 1Salbutamol Sulphate
44 1Sodium Picosulfate
45 1Tafasitamab
46 2Tenecteplase
47 1Tiotropium Bromide
48 1Tipranavir
49 1Tramazoline Hydrochloride Monohydrate
50 1Tylosin
51 1Zongertinib
52 12Blank
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01 7Active
02 10Inactive
03 70Blank
01 20Valid
02 3Withdrawn by Holder
03 64Blank
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01 1219MF10046
02 1220MF10081
03 1220MF10085
04 1220MF10132
05 1221MF10144
06 1224MF10100
07 1230MF10030
08 1230MF40020
09 1230MF40021
10 1230MF40022
11 1230MF40023
12 1307MF10088
13 1307MF10089
14 74Blank
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01 87Blank
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01 120050831-45-B-117-04
02 120080627-88-D-82-06
03 120120919-188-I-64-01
04 120121114-148-I-85-06
05 120130109-194-I-63-01
06 120211028-209-J-1132
07 120220517-209-J-1298
08 1Su15-10-ND
09 1Su15-11-ND
10 1Su15-12-ND
11 1Su15-13-ND
12 1Su15-8-ND
13 1Su15-9-ND
14 1Su2807-4-ND
15 1Su2807-5-ND
16 1Su2807-6-ND
17 1Su2807-7-ND
18 1Su426-1-ND
19 1Su426-2-ND
20 1Su426-3-ND
21 67Blank
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01 112714-011
02 112714-016
03 112714-031
04 112714-034
05 112714-036
06 112714-049
07 112714-082
08 112714-083
09 112714-084
10 112714-133
11 112714-153
12 112714-201
13 112714-213
14 112714-219
15 112714-234
16 112714-236
17 112714-301
18 112714-350
19 112714-901
20 112714-915
21 112714-916
22 112714-920
23 112714-930
24 151869-0007
25 151869-0008
26 151869-0009
27 151869-0015
28 151869-0020
29 151869-0030
30 151869-0040
31 151869-0050
32 168594-070
33 168594-080
34 168594-090
35 168594-130
36 52Blank
01 13724
02 13725
03 13770
04 15064
05 15125
06 15164
07 15310
08 15473
09 15601
10 15840
11 16207
12 16260
13 75Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15003
Submission : 2000-09-11
Status : Active
Type : II
Certificate Number : R1-CEP 2011-311 - Rev 01
Issue Date : 2021-03-17
Type : Chemical
Substance Number : 2411
Status : Valid
Registration Number : 224MF10100
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2012-05-23
Latest Date of Registration :
Registrant Name : Boehringer Ingelheim Korea
Registration Date : 2013-01-09
Registration Number : 20130109-194-I-63-01
Manufacturer Name : Boehringer Ingelheim GmbH & Co.KG
Manufacturer Address : Binger Strasse 173 55216 Ingelheim am Rhein, Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19620
Submission : 2006-07-24
Status : Active
Type : II
Certificate Number : R1-CEP 2006-123 - Rev 00
Issue Date : 2012-09-25
Type : Chemical
Substance Number : 2135
Status : Valid
Registration Number : 221MF10144
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2009-07-09
Latest Date of Registration :
Registrant Name : Novo Nordisk Pharmaceuticals Inc.
Registration Date : 2021-10-28
Registration Number : 20211028-209-J-1132
Manufacturer Name : Boehringer Ingelheim Pharma GmbH & Co KG
Manufacturer Address : Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2002-142 - Rev 03
Issue Date : 2011-02-10
Type : Chemical
Substance Number : 1489
Status : Valid
Registration Number : 220MF10085
Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni
Initial Date of Registration : 2008-03-18
Latest Date of Registration :
Registrant Name : Opella Healthcare Korea Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-45-B-117-04
Manufacturer Name : Bidachem SpA
Manufacturer Address : SS 11(Padana Superiore), 8 24040 Fornovo San Giovanni

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 1996-005 - Rev 05
Issue Date : 2015-10-08
Type : Chemical
Substance Number : 919
Status : Valid
Registration Number : 220MF10081
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2008-03-14
Latest Date of Registration :
NDC Package Code : 12714-049
Start Marketing Date : 2011-05-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Boehringer Ingelheim Korea
Registration Date : 2012-09-19
Registration Number : 20120919-188-I-64-01
Manufacturer Name : Boehringer Ingelheim Pharma GmbH & Co. K.G.
Manufacturer Address : Binger Strasse 173, 55216 Ingelheim am Rhein

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21413
Submission : 2008-03-12
Status : Active
Type : II
Certificate Number : R1-CEP 2011-171 - Rev 00
Issue Date : 2019-01-24
Type : Chemical
Substance Number : 2416
Status : Valid
Registrant Name : Boehringer Ingelheim Korea
Registration Date : 2022-05-17
Registration Number : 20220517-209-J-1298
Manufacturer Name : Boehringer Ingelheim Pharma GmbH & Co. K.G.
Manufacturer Address : Binger Strasse 173, 55216 Ingelheim am Rhien, Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14258
Submission : 1999-06-25
Status : Active
Type : II
Certificate Number : CEP 1997-004 - Rev 05
Issue Date : 2024-05-30
Type : Chemical
Substance Number : 687
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2003-068 - Rev 00
Issue Date : 2009-11-04
Type : Chemical
Substance Number : 1031
Status : Valid
Registration Number : 220MF10132
Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni
Initial Date of Registration : 2008-05-20
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 219MF10046
Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni
Initial Date of Registration : 2007-02-13
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2003-067 - Rev 00
Issue Date : 2010-01-07
Type : Chemical
Substance Number : 595
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2004-037 - Rev 00
Issue Date : 2010-01-07
Type : Chemical
Substance Number : 595
Status : Valid

Boehringer Ingelheim Gmbh is a supplier offers 51 products (APIs, Excipients or Intermediates).
Find Epinastine Hydrochloride bulk with DMF, CEP, JDMF offered by Boehringer Ingelheim Gmbh
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