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05 Jun 2026
// PRESS RELEASE
05 Jun 2026
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Latest Content by PharmaCompass
KEY PRODUCTS
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01 1Acarbose
02 1Alpha-Cyclodextrin
03 1Aspirin
04 2Azelaic Acid
05 1CAS 50-28-2
06 2Ciprofloxacin
07 2Ciprofloxacin Hydrochloride
08 1Clotrimazole
09 2Cyproterone Acetate
10 1Dienogest
11 1Drospirenone
12 1Enrofloxacin
13 3Estradiol
14 1Estradiol Benzoate
15 3Estradiol Valerate
16 1Estriol
17 2Ethinyl Estradiol
18 1Etofenamate
19 2Finerenone
20 1Gadobutrol
21 1Gadolinium Ethoxybenzyl Dtpa
22 1Gestodene
23 1Hydrocortisone
24 1Iloprost
25 2Iopromide
26 2Levonorgestrel
27 1Medroxyprogesterone Acetate
28 1Mesalazine
29 1Methylprednisolone Aceponate
30 1Molidustat
31 1Moxifloxacin
32 2Moxifloxacin Hydrochloride
33 2Nifedipine
34 1Nisoldipine
35 3Norethisterone
36 1Norethisterone Acetate
37 1Pentetic Acid
38 2Pradofloxacin
39 1Regorafenib
40 2Rivaroxaban
41 1Sorafenib
42 2Testosterone
43 1Testosterone Enanthate
44 2Testosterone Undecanoate
45 2Blank
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01 28Active
02 2Inactive
03 36Blank
01 31Valid
02 35Blank
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01 1218MF10829
02 1219MF10281
03 1222MF10134
04 1224MF10001
05 62Blank
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01 66Blank
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01 120071228-85-D-49-07
02 120110429-134-H-54-03
03 120110516-85-D-92-17
04 120121228-181-I-165-04
05 120121228-181-I-165-04(1)
06 120121228-181-I-165-04(2)
07 120121228-181-I-166-03
08 120121228-181-I-166-03(1)
09 120121228-181-I-166-03(2)
10 120130104-153-I-168-01
11 120180706-210-J-240
12 120210810-209-J-1087
13 120210924-209-J-1109
14 120210924-209-J-1109(1)
15 120220215-211-J-1180
16 120221024-134-H-404-06
17 1309-1-ND
18 1309-2-ND
19 1309-3-ND
20 1Su212-10-ND
21 1Su212-8-ND
22 1Su212-9-ND
23 1Su2420-1-ND
24 1Su2420-3-ND
25 1Su2420-4-ND
26 1Su2420-5-ND
27 40Blank
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01 112527-0181
02 112527-0385
03 112527-0386
04 112527-0517
05 112527-0537
06 112527-0540
07 112527-0580
08 112527-0787
09 112527-0801
10 112527-1721
11 112866-1008
12 112866-1009
13 112866-1010
14 112866-1011
15 112866-1013
16 112866-1014
17 112866-1016
18 112866-1018
19 112866-1019
20 112866-1099
21 112866-1168
22 112866-1169
23 112866-1175
24 43Blank
01 66Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-11
Pay. Date : 2013-07-05
DMF Number : 1985
Submission : 1972-08-16
Status : Active
Type : II
Certificate Number : R1-CEP 1996-079 - Rev 07
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 140
Status : Valid
Registration Number : 218MF10829
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2006-10-20
Latest Date of Registration :
NDC Package Code : 12866-1168
Start Marketing Date : 2017-05-10
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-05
Pay. Date : 2013-01-28
DMF Number : 2726
Submission : 1976-08-05
Status : Active
Type : II
Certificate Number : R1-CEP 2013-050 - Rev 00
Issue Date : 2018-07-23
Type : Chemical
Substance Number : 234
Status : Valid
Registration Number : 219MF10281
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2007-09-10
Latest Date of Registration :
NDC Package Code : 12866-1013
Start Marketing Date : 2017-05-13
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8539
Submission : 1990-04-23
Status : Active
Type : II
Certificate Number : R1-CEP 2007-101 - Rev 03
Issue Date : 2018-03-06
Type : Chemical
Substance Number : 2089
Status : Valid
Registrant Name : Bayer Korea Co., Ltd.
Registration Date : 2013-01-04
Registration Number : 20130104-153-I-168-01
Manufacturer Name : Bayer AG
Manufacturer Address : Friedrich-Ebert-Str. 217-333, D-42117 Wuppertal
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3379
Submission : 1978-11-02
Status : Active
Type : II
Registration Number : 222MF10134
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2010-04-13
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8993
Submission : 1991-02-28
Status : Active
Type : II
Certificate Number : R1-CEP 1998-102 - Rev 06
Issue Date : 2017-03-06
Type : Chemical
Substance Number : 1089
Status : Valid
Registrant Name : Bayer Korea Co., Ltd.
Registration Date : 2011-05-16
Registration Number : 20110516-85-D-92-17
Manufacturer Name : Bayer AG
Manufacturer Address : Friedrich-Ebert-Str. 217-333, 42117 Wuppertal, Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8134
Submission : 1989-07-14
Status : Active
Type : II
Certificate Number : CEP 1998-103 - Rev 07
Issue Date : 2025-01-22
Type : Chemical
Substance Number : 888
Status : Valid
NDC Package Code : 12527-0540
Start Marketing Date : 2016-09-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Bayer Korea Co., Ltd.
Registration Date : 2007-12-31
Registration Number : 20071228-85-D-49-07
Manufacturer Name : Bayer AG
Manufacturer Address : Friedrich-elbert-Str. 217-333, 42117, wuppertal
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12138
Submission : 1996-09-09
Status : Active
Type : II
Certificate Number : R1-CEP 2009-070 - Rev 02
Issue Date : 2022-07-27
Type : Chemical
Substance Number : 2404
Status : Valid
Registrant Name : Bayer Korea Co., Ltd.
Registration Date : 2006-03-02
Registration Number : 309-2-ND
Manufacturer Name : Bayer AG@[Micro-process Manufacturer] Bayer AG
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen, Germany@Max-Dohrn-Straße 8 10589 Berlin, Germany
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-28
Pay. Date : 2013-01-08
DMF Number : 4684
Submission : 1982-10-13
Status : Active
Type : II
Certificate Number : R2-CEP 1995-017 - Rev 04
Issue Date : 2017-03-01
Type : Chemical
Substance Number : 821
Status : Valid
NDC Package Code : 12866-1169
Start Marketing Date : 2017-05-12
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2020-04-01
Registration Number : 20121228-181-I-166-03(2)
Manufacturer Name : Bayer AG "Bergkamen"@Bayer AG "Berlin-Charlottenburg"
Manufacturer Address : Ernst-Schering-Straße 14, 59192 Bergkamen, Germany@Max-Dohrn-Straße 8, 10589 Berlin, Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13061
Submission : 1998-07-07
Status : Active
Type : II
Certificate Number : CEP 2017-275 - Rev 02
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2735
Status : Valid
Registrant Name : Bayer Korea Co., Ltd.
Registration Date : 2004-11-05
Registration Number : 309-1-ND
Manufacturer Name : Bayer AG@Dynamit Nobel GmbH Explosivstoff- und Systemtechnik
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen, Germany@Kalkstraße 218 51377 Leverkusen Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8178
Submission : 1989-08-15
Status : Active
Type : II
Certificate Number : CEP 2020-273 - Rev 01
Issue Date : 2025-10-31
Type : Chemical
Substance Number : 1753
Status : Valid
Registrant Name : Bayer Korea Co., Ltd.
Registration Date : 2018-07-06
Registration Number : 20180706-210-J-240
Manufacturer Name : Bayer AG
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen Germany
Bayer Ag is a supplier offers 56 products (APIs, Excipients or Intermediates).
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