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Bausch Health
FDA Orange Book

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

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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Inke S.A: APIs manufacturing plant.

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Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Bausch Health

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 915 News #PharmaBuzz

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

ACTIVE PHARMA INGREDIENTS

10 All APIs, 5 USDMF, 1 CEP/COS, 4 KDMF

10 All APIs
5 USDMF
1 CEP/COS
4 KDMF

DEVELOPMENTS

206 Drugs in Development

206 Drugs in Development

FINISHED DOSAGE FORMULATIONS

323 FDF Dossiers, 140 FDA Orange Book, 57 Europe, 126 Canada

323 FDF Dossiers
140 FDA Orange Book
57 Europe
126 Canada

REF. STANDARDS & IMPURITIES

1 Others

1 Others

INSPECTIONS & REGISTRATIONS

22 FDA, 7 EDQM, 4 GDUFA

22 FDA
7 EDQM
4 GDUFA

Xls

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FILTER :

filter Active Ingredients Reset all filters

140 All

01 2ACETAMINOPHEN; BUTALBITAL

02 1ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

03 2ACETAMINOPHEN; CODEINE PHOSPHATE

04 1AMINOPHYLLINE

05 1ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

06 1BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

07 2BALSALAZIDE DISODIUM

08 1BENZOYL PEROXIDE; ERYTHROMYCIN

09 1BEXAROTENE

10 1BRODALUMAB

11 1CARBIDOPA

12 4CHLORDIAZEPOXIDE

13 5CHLORDIAZEPOXIDE HYDROCHLORIDE

14 2CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

15 1CICLOPIROX

16 1DICLOFENAC SODIUM

17 18DILTIAZEM HYDROCHLORIDE

18 1DILTIAZEM MALATE; ENALAPRIL MALEATE

19 2DIPHENHYDRAMINE HYDROCHLORIDE

20 1ERYTHROMYCIN

21 2FLUOXYMESTERONE

22 2FLURAZEPAM HYDROCHLORIDE

23 1FOLIC ACID

24 1GATIFLOXACIN

25 1GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

26 2GRISEOFULVIN, MICROCRYSTALLINE

27 2GRISEOFULVIN, MICROSIZE

28 9HYDROCORTISONE

29 1ISONIAZID

30 3ISOSORBIDE DINITRATE

31 3LEVODOPA

32 2LEVORPHANOL TARTRATE

33 2MEPROBAMATE

34 2METHOXSALEN

35 2METHYLTESTOSTERONE

36 1MINOCYCLINE HYDROCHLORIDE

37 1MONOBENZONE

38 5NIFEDIPINE

39 3NITROGLYCERIN

40 2PENICILLAMINE

41 1PENTOBARBITAL SODIUM

42 3PERGOLIDE MESYLATE

43 1PHENDIMETRAZINE TARTRATE

44 2PIPERACETAZINE

45 2PREDNICARBATE

46 1PREDNISOLONE

47 1PREDNISONE

48 2PRIMIDONE

49 1PROPOXYPHENE HYDROCHLORIDE

50 1QUINIDINE SULFATE

51 2RAUWOLFIA SERPENTINA ROOT

52 2RESERPINE

53 3SECOBARBITAL SODIUM

54 1SODIUM NITROPRUSSIDE

55 1SULFISOXAZOLE

56 2TETRACYCLINE HYDROCHLORIDE

57 2THEOPHYLLINE

58 3TRAMADOL HYDROCHLORIDE

59 9TRETINOIN

60 1TRIOXSALEN

61 3VENLAFAXINE HYDROCHLORIDE

filter Dosage Reset all filters

140 All

01 24CAPSULE, EXTENDED RELEASE;ORAL

02 26CAPSULE;ORAL

03 10CREAM;TOPICAL

04 3FILM, EXTENDED RELEASE;TRANSDERMAL

05 3GEL;TOPICAL

06 4INJECTABLE;INJECTION

07 7LOTION;TOPICAL

08 1OINTMENT;OPHTHALMIC

09 1OINTMENT;TOPICAL

10 1POWDER, EXTENDED RELEASE;DENTAL

11 1SOLUTION/DROPS;OPHTHALMIC

12 1SOLUTION; OPHTHALMIC

13 3SOLUTION;TOPICAL

14 2SUSPENSION;ORAL

15 1SWAB;TOPICAL

16 10TABLET, EXTENDED RELEASE;ORAL

17 1TABLET;BUCCAL

18 38TABLET;ORAL

19 3TABLET;SUBLINGUAL

filter Dosage Strength Reset all filters

140 All

01 10.02%

02 10.025%

03 10.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

04 10.025MG;2.5MG

05 50.05%

06 10.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

07 10.1%

08 20.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

09 10.1MG

10 10.1MG/HR

11 10.25MG

12 10.2MG/HR

13 10.3%

14 10.5%

15 10.6MG/HR

16 31%

17 21% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

18 11.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

19 6100MG

20 1100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

21 1100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

22 1105MG

23 710MG

24 210MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

25 3120MG

26 1120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

27 1120MG/5ML;12MG/5ML

28 3125MG

29 1125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

30 115MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

31 2180MG

32 1180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

33 11MG

34 12%

35 22.5%

36 22.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

37 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

38 120%

39 3200MG

40 1200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

41 1210MG/1.5ML

42 2240MG

43 5250MG

44 1250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

45 425MG

46 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

47 125MG/ML

48 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

49 12MG/ML

50 3300MG

51 1300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

52 1300MG;30MG

53 330MG

54 130MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

55 1325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

56 1325MG;50MG;40MG;30MG

57 1360MG

58 1400MG

59 1420MG

60 15%;3%

61 1500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

62 4500MG

63 450MG

64 65MG

65 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

66 360MG

67 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

68 1650MG;50MG

69 165MG

70 1750MG

71 175MG

72 18% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

73 290MG

74 190MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

75 1EQ 0.05MG BASE

76 1EQ 0.25MG BASE

77 1EQ 150MG BASE

78 1EQ 180MG HYDROCHLORIDE;5MG

79 2EQ 1MG BASE

80 1EQ 37.5MG BASE

81 1EQ 4MG MALEATE;EQ 5MG BITARTRATE

82 1EQ 75MG BASE

83 1EQ 8MG MALEATE;EQ 10MG BITARTRATE

filter Regulatory Info Reset all filters

140 All

01 112DISCN

02 26RX

03 2Blank

List of Suppliers

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01

Brand Name : PHRENILIN

FNCE

Not Confirmed

Brand Name : PHRENILIN

FNCE

Not Confirmed

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RLD : Yes

TE Code :

ACETAMINOPHEN; BUTALBITAL

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : PHRENILIN

Dosage Strength : 325MG;50MG **Federal Reg...

Approval Date : 1985-06-19

Application Number : 87811

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

02

Brand Name : PHRENILIN FORTE

FNCE

Not Confirmed

Brand Name : PHRENILIN FORTE

FNCE

Not Confirmed

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Digital Content

RLD : No

TE Code :

ACETAMINOPHEN; BUTALBITAL

Bausch Health

Dosage Form : CAPSULE; ORAL

Proprietary Name : PHRENILIN FORTE

Dosage Strength : 650MG;50MG

Approval Date : 1985-06-19

Application Number : 88831

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

03

Brand Name : PHRENILIN WITH CAFFE...

FNCE

Not Confirmed

Brand Name : PHRENILIN WITH CAFFE...

FNCE

Not Confirmed

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Digital Content

RLD : No

TE Code :

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Bausch Health

Dosage Form : CAPSULE; ORAL

Proprietary Name : PHRENILIN WITH CAFFEINE ...

Dosage Strength : 325MG;50MG;40MG;30MG

Approval Date : 2001-08-22

Application Number : 74911

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

04

Brand Name : ACETAMINOPHEN AND CO...

FNCE

Not Confirmed

Brand Name : ACETAMINOPHEN AND CO...

FNCE

Not Confirmed

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Digital Content

RLD : No

TE Code :

ACETAMINOPHEN; CODEINE PHOSPHATE

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : ACETAMINOPHEN AND CODEIN...

Dosage Strength : 300MG;30MG

Approval Date : 1982-01-01

Application Number : 85896

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

05

Brand Name : CAPITAL AND CODEINE

FNCE

Not Confirmed

Brand Name : CAPITAL AND CODEINE

FNCE

Not Confirmed

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Digital Content

RLD : No

TE Code :

ACETAMINOPHEN; CODEINE PHOSPHATE

Bausch Health

Dosage Form : SUSPENSION; ORAL

Proprietary Name : CAPITAL AND CODEINE

Dosage Strength : 120MG/5ML;12MG/5ML

Approval Date : 1982-01-01

Application Number : 86024

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

06

Brand Name : AMINOPHYLLINE

FNCE

Not Confirmed

Brand Name : AMINOPHYLLINE

FNCE

Not Confirmed

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Digital Content

RLD : No

TE Code :

AMINOPHYLLINE

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : AMINOPHYLLINE

Dosage Strength : 200MG

Approval Date : 1982-01-01

Application Number : 84563

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

07

Brand Name : DIPHENOXYLATE HYDROC...

FNCE

Not Confirmed

Brand Name : DIPHENOXYLATE HYDROC...

FNCE

Not Confirmed

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Digital Content

RLD : No

TE Code :

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : DIPHENOXYLATE HYDROCHLOR...

Dosage Strength : 0.025MG;2.5MG

Approval Date : 1982-02-16

Application Number : 87195

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

08

Brand Name : NEO-POLYCIN

FNCE

Not Confirmed

Brand Name : NEO-POLYCIN

FNCE

Not Confirmed

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Digital Content

RLD : No

TE Code :

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Bausch Health

Dosage Form : OINTMENT; OPHTHALMIC

Proprietary Name : NEO-POLYCIN

Dosage Strength : 500 UNITS/GM;EQ 3.5MG BA...

Approval Date : 1982-01-01

Application Number : 60647

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

09

Brand Name : COLAZAL

FNCE

Not Confirmed

Brand Name : COLAZAL

FNCE

Not Confirmed

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RLD : Yes

TE Code : AB

BALSALAZIDE DISODIUM

Bausch Health

Dosage Form : CAPSULE; ORAL

Proprietary Name : COLAZAL

Dosage Strength : 750MG

Approval Date : 2000-07-18

Application Number : 20610

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product
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10

Brand Name : GIAZO

FNCE

Not Confirmed

Brand Name : GIAZO

FNCE

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

BALSALAZIDE DISODIUM

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : GIAZO

Dosage Strength : 1.1GM **Federal Register...

Approval Date : 2012-02-03

Application Number : 22205

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
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Contact Bausch Health and get a quotation

Bausch Health is a supplier offers 3 products (APIs, Excipients or Intermediates).

Find a price of Metformin bulk with DMF offered by Bausch Health

Find a price of Pyridostigmine bulk with DMF offered by Bausch Health

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