Bayer | DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Bayer AG
USDMF

FAMAR CDMO- From early development to commercial manufacturing.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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pharmacompass-1-m-2026-04-20

AbbVie Contract Manufacturing partners globally to develop, scale, and manufacture pharmaceutical products successfully.

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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pharmacompass-2-m-2026-04-20

Bayer AG

VIRTUAL BOOTH, Contact Details

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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 1963 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
1963 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

66 All APIs, 30 USDMF, 31 CEP/COS, 4 JDMF, 26 KDMF, 23 NDC API, 13 Listed APIs

66 All APIs
30 USDMF
31 CEP/COS
4 JDMF
26 KDMF
23 NDC API
13 Listed APIs

DEVELOPMENTS

1275 Drugs in Development

1275 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2334 FDF Dossiers, 368 FDA Orange Book, 1547 Europe, 144 Canada, 83 Australia, 192 South Africa

2334 FDF Dossiers
368 FDA Orange Book
1547 Europe
144 Canada
83 Australia
192 South Africa

EXCIPIENTS

4 All Excipients, 4 USDMF

4 All Excipients
4 USDMF

INSPECTIONS & REGISTRATIONS

115 FDA, 8 EDQM, 2 GDUFA

115 FDA
8 EDQM
2 GDUFA

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30 All

01 1ACARBOSE

02 1AZELAIC ACID

03 1AZELAIC ACID (A)

04 1CIPROFLOXACIN

05 1CIPROFLOXACIN HYDRATED DRUG SUBSTANCE

06 1CIPROFLOXACIN HYDROCHLORIDE

07 1DIENOGEST

08 1DROSPIRENONE

09 1EOB-DTPA

10 1ESTRADIOL

11 1ESTRADIOL VALERATE

12 1ETHINYLESTRADIOL

13 1ETHINYLESTRADIOL-BETA-CYCLODEXTRIN-CLATHRATE

14 1GADOBUTROL

15 1ILOPROST

16 1IOPROMIDE

17 1LEVONORGESTREL

18 1MEDROXYPROGESTERONE ACETATE

19 1MOLIDUSTAT SODIUM (MICRONIZED) DRUG SUBSTANCE

20 1NISOLDIPINE

21 1NORETHINDRONE

22 1NORETHINDRONE ACETATE

23 1NORGESTREL

24 1RECOMBINANT ADENO-ASSOCIATED VIRUS (RAAV)

25 1RIVAROXABAN (MICRONIZED) DRUG SUBSTANCE

26 1RIVAROXABAN COATED TABLETS, 10 MG

27 1TESTOSTERONE

28 1TESTOSTERONE ENANTHATE

29 1TESTOSTERONE UNDECANOATE

30 1TESTOSTERONE UNDECANOATE 750 MG I.M.

filter Holder Reset all filters

30 All

01 1ASKLEPIOS BIOPHARMACEUTICAL INC

02 29BAYER AG

filter Country Reset all filters

30 All

01 29Germany

02 1U.S.A

filter Status Reset all filters

30 All

01 28Active

02 2Inactive

filter GDUFA DMF Review Reset all filters

30 All

01 7Complete

02 23Blank

List of Suppliers

Supplier Virtual Booth

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01

Acarbose

PEGS Boston Summit

Not Confirmed

Acarbose

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8539

Submission : 1990-04-23

Status : Active

Type : II

Product
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02

Azelaic Acid

PEGS Boston Summit

Not Confirmed

Azelaic Acid

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9289

Submission : 1991-08-07

Status : Active

Type : II

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03

Azelaic Acid (a)

PEGS Boston Summit

Not Confirmed

Azelaic Acid (a)

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28190

Submission : 2014-06-26

Status : Active

Type : II

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04

Ciprofloxacin

PEGS Boston Summit

Not Confirmed

Ciprofloxacin

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8993

Submission : 1991-02-28

Status : Active

Type : II

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05

Ciprofloxacin Hydrated Drug Substanc...

PEGS Boston Summit

Not Confirmed

Ciprofloxacin Hydrated Drug Substanc...

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10353

Submission : 1993-07-13

Status : Active

Type : II

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06

Ciprofloxacin Hydrochloride

PEGS Boston Summit

Not Confirmed

Ciprofloxacin Hydrochloride

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8134

Submission : 1989-07-14

Status : Active

Type : II

Product
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07

Dienogest

PEGS Boston Summit

Not Confirmed

Dienogest

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14014

Submission : 1999-02-26

Status : Active

Type : II

Product
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08

Drospirenone

PEGS Boston Summit

Not Confirmed

Drospirenone

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12138

Submission : 1996-09-09

Status : Active

Type : II

Product
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09

Eob-dtpa

PEGS Boston Summit

Not Confirmed

Eob-dtpa

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20414

Submission : 2007-05-14

Status : Active

Type : II

Product
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10

Estradiol

PEGS Boston Summit

Not Confirmed

Estradiol

PEGS Boston Summit

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-28

Pay. Date : 2013-01-08

DMF Number : 4684

Submission : 1982-10-13

Status : Active

Type : II

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1
2
3

Contact Bayer and get a quotation

Bayer is a supplier offers 56 products (APIs, Excipients or Intermediates).

Find Ethinyl Estradiol bulk with DMF, CEP, JDMF offered by Bayer

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