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PAI Pharmaceutical Associates
FDA Orange Book

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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PAI Pharmaceutical Associates

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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow

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FINISHED DOSAGE FORMULATIONS

128 FDF Dossiers, 128 FDA Orange Book

128 FDF Dossiers
128 FDA Orange Book

INSPECTIONS & REGISTRATIONS

1 WHO-GMP

1 WHO-GMP

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filter Active Ingredients Reset all filters

128 All

01 3ACETAMINOPHEN; HYDROCODONE BITARTRATE

02 1AMANTADINE HYDROCHLORIDE

03 1BROMPHENIRAMINE MALEATE

04 1BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

05 5CEFOTETAN DISODIUM

06 4CEFTAZIDIME

07 3CEFTAZIDIME SODIUM

08 5CEFUROXIME SODIUM

09 3CETIRIZINE HYDROCHLORIDE

10 1CHLORHEXIDINE GLUCONATE

11 1CHLORPHENIRAMINE MALEATE

12 2CHLORPROMAZINE HYDROCHLORIDE

13 3CIMETIDINE HYDROCHLORIDE

14 1CITALOPRAM HYDROBROMIDE

15 1CLINDAMYCIN PHOSPHATE

16 4CLOBETASOL PROPIONATE

17 2CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

18 1CYCLOSPORINE

19 1CYPROHEPTADINE HYDROCHLORIDE

20 2DESONIDE

21 1DESOXIMETASONE

22 1DEXCHLORPHENIRAMINE MALEATE

23 1DICLOFENAC SODIUM

24 1DIPHENHYDRAMINE HYDROCHLORIDE

25 1DOXEPIN HYDROCHLORIDE

26 2EDROPHONIUM CHLORIDE

27 1ERYTHROMYCIN

28 1ETHOSUXIMIDE

29 1FLUOCINOLONE ACETONIDE

30 3FLUOCINONIDE

31 1FLUOXETINE HYDROCHLORIDE

32 2FLUPHENAZINE HYDROCHLORIDE

33 1GABAPENTIN

34 1HALOPERIDOL LACTATE

35 2HYDROCORTISONE

36 1HYDROXYZINE HYDROCHLORIDE

37 2IBUPROFEN

38 2LACTULOSE

39 1LEVETIRACETAM

40 2LIDOCAINE HYDROCHLORIDE

41 1LIDOCAINE; PRILOCAINE

42 1LITHIUM CITRATE

43 2LORATADINE

44 1LORAZEPAM

45 1MIDAZOLAM HYDROCHLORIDE

46 2MORPHINE SULFATE

47 1NORTRIPTYLINE HYDROCHLORIDE

48 1NYSTATIN

49 1NYSTATIN; TRIAMCINOLONE ACETONIDE

50 1ONDANSETRON HYDROCHLORIDE

51 1ORPHENADRINE CITRATE

52 2OXYBUTYNIN CHLORIDE

53 2OXYCODONE HYDROCHLORIDE

54 1PERPHENAZINE

55 1PHENYTOIN

56 2PHYTONADIONE

57 2POTASSIUM CHLORIDE

58 3PREDNISOLONE

59 5PREDNISOLONE SODIUM PHOSPHATE

60 2PROMETHAZINE HYDROCHLORIDE

61 2PROPRANOLOL HYDROCHLORIDE

62 4RANITIDINE HYDROCHLORIDE

63 1RISPERIDONE

64 1SODIUM POLYSTYRENE SULFONATE

65 2SULFAMETHOXAZOLE; TRIMETHOPRIM

66 2THEOPHYLLINE

67 2THIORIDAZINE HYDROCHLORIDE

68 3TRIAMCINOLONE ACETONIDE

69 1TRIHEXYPHENIDYL HYDROCHLORIDE

70 1TRIPROLIDINE HYDROCHLORIDE

71 1VALPROIC ACID

72 2VANCOMYCIN HYDROCHLORIDE

filter Dosage Reset all filters

128 All

01 2CAPSULE;ORAL

02 9CONCENTRATE;ORAL

03 4CREAM;TOPICAL

04 5ELIXIR;ORAL

05 1GEL;TOPICAL

06 24INJECTABLE;INJECTION

07 1INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

08 5LOTION;TOPICAL

09 6OINTMENT;TOPICAL

10 1POWDER;ORAL, RECTAL

11 1SOLUTION, ELIXIR;ORAL

12 1SOLUTION;DENTAL

13 32SOLUTION;ORAL

14 1SOLUTION;ORAL, RECTAL

15 6SOLUTION;TOPICAL

16 6SUSPENSION;ORAL

17 1SYRUP; ORAL

18 22SYRUP;ORAL

filter Dosage Strength Reset all filters

128 All

01 10.01%

02 10.025%

03 80.05%

04 20.1%

05 10.12%

06 10.25%

07 30.5%

08 11.25MG/5ML

09 11.5%

10 1100,000 UNITS/GM;0.1%

11 1100,000 UNITS/ML

12 4100MG/5ML

13 4100MG/ML

14 210GM/15ML

15 210MG/5ML

16 210MG/5ML;6.25MG/5ML

17 110MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

18 210MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

19 112.5MG/5ML

20 1125MG/5ML

21 215MG/5ML

22 116MG/5ML

23 11GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

24 11MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

25 21MG/ML

26 22%

27 12.5%;2.5%

28 12.5MG/5ML

29 2200MG/5ML;40MG/5ML

30 120MEQ/15ML

31 120MG/5ML

32 3250MG/5ML

33 12GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

34 52MG/5ML

35 12MG/5ML;10MG/5ML;30MG/5ML

36 12MG/ML

37 230MG/ML

38 130MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

39 1325MG/15ML;10MG/15ML

40 1325MG/15ML;7.5MG/15ML

41 14%

42 140MEQ/15ML

43 140MG/5ML

44 1453.6GM/BOT

45 1500MG/15ML;7.5MG/15ML

46 1500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

47 150MG/5ML

48 85MG/5ML

49 15MG/ML

50 26.25MG/5ML

51 16GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

52 280MG/15ML

53 1EQ 1% BASE

54 1EQ 1.5GM BASE/VIAL

55 1EQ 10GM BASE/VIAL

56 3EQ 10MG BASE/5ML

57 2EQ 10MG BASE/ML

58 1EQ 125MG BASE

59 1EQ 15MG BASE/5ML

60 2EQ 15MG BASE/ML

61 1EQ 1GM BASE/VIAL

62 1EQ 1MG BASE/ML

63 2EQ 20MG BASE/5ML

64 2EQ 20MG BASE/ML

65 1EQ 250MG BASE

66 1EQ 25MG BASE/ML

67 1EQ 2GM BASE/VIAL

68 2EQ 2MG BASE/ML

69 3EQ 300MG BASE/5ML

70 1EQ 300MG CARBONATE/5ML

71 1EQ 30MG BASE/5ML

72 1EQ 30MG BASE/ML

73 2EQ 40MG BASE/ML

74 1EQ 4MG BASE/5ML

75 1EQ 50MG BASE/100ML

76 1EQ 5MG BASE/5ML

77 1EQ 7.5GM BASE/VIAL

78 1EQ 750MG BASE/VIAL

filter Regulatory Info Reset all filters

128 All

01 89DISCN

02 37RX

03 2Blank

List of Suppliers

Supplier Virtual Booth

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01

Brand Name : HYDROCODONE BITARTRA...

U.S.A

Antibody Engineering

Not Confirmed

Brand Name : HYDROCODONE BITARTRA...

U.S.A

Antibody Engineering

Not Confirmed

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RLD : No

TE Code :

ACETAMINOPHEN; HYDROCODONE BITARTRATE

PHARM ASSOC

Dosage Form : SOLUTION; ORAL

Proprietary Name : HYDROCODONE BITARTRATE A...

Dosage Strength : 500MG/15ML;7.5MG/15ML

Approval Date : 1998-03-13

Application Number : 40182

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
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02

Brand Name : HYDROCODONE BITARTRA...

U.S.A

Antibody Engineering

Not Confirmed

Brand Name : HYDROCODONE BITARTRA...

U.S.A

Antibody Engineering

Not Confirmed

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Digital Content

RLD : No

TE Code :

ACETAMINOPHEN; HYDROCODONE BITARTRATE

PHARM ASSOC

Dosage Form : SOLUTION; ORAL

Proprietary Name : HYDROCODONE BITARTRATE A...

Dosage Strength : 325MG/15ML;10MG/15ML

Approval Date : 2008-04-18

Application Number : 40834

RX/OTC/DISCN : RX

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

03

Brand Name : HYDROCODONE BITARTRA...

U.S.A

Antibody Engineering

Not Confirmed

Brand Name : HYDROCODONE BITARTRA...

U.S.A

Antibody Engineering

Not Confirmed

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Digital Content

RLD : No

TE Code : AA

ACETAMINOPHEN; HYDROCODONE BITARTRATE

PHARM ASSOC

Dosage Form : SOLUTION; ORAL

Proprietary Name : HYDROCODONE BITARTRATE A...

Dosage Strength : 325MG/15ML;7.5MG/15ML

Approval Date : 2013-05-10

Application Number : 40838

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

Stock Recap
#PipelineProspector

04

Brand Name : AMANTADINE HYDROCHLO...

U.S.A

Antibody Engineering

Not Confirmed

Brand Name : AMANTADINE HYDROCHLO...

U.S.A

Antibody Engineering

Not Confirmed

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Digital Content

RLD : No

TE Code : AA

AMANTADINE HYDROCHLORIDE

PHARM ASSOC

Dosage Form : SYRUP; ORAL

Proprietary Name : AMANTADINE HYDROCHLORIDE

Dosage Strength : 50MG/5ML

Approval Date : 1995-07-17

Application Number : 74509

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

Stock Recap
#PipelineProspector

05

Brand Name : BROMPHENIRAMINE MALE...

U.S.A

Antibody Engineering

Not Confirmed

Brand Name : BROMPHENIRAMINE MALE...

U.S.A

Antibody Engineering

Not Confirmed

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RLD : No

TE Code :

BROMPHENIRAMINE MALEATE

PHARM ASSOC

Dosage Form : ELIXIR; ORAL

Proprietary Name : BROMPHENIRAMINE MALEATE

Dosage Strength : 2MG/5ML

Approval Date : 1982-01-01

Application Number : 87517

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

06

Brand Name : BROMPHENIRAMINE MALE...

U.S.A

Antibody Engineering

Not Confirmed

Brand Name : BROMPHENIRAMINE MALE...

U.S.A

Antibody Engineering

Not Confirmed

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RLD : No

TE Code : AA

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

PHARM ASSOC

Dosage Form : SYRUP; ORAL

Proprietary Name : BROMPHENIRAMINE MALEATE,...

Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5M...

Approval Date : 2014-07-21

Application Number : 202940

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

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07

Brand Name : CEFOTAN

Antibody Engineering

Not Confirmed

Brand Name : CEFOTAN

Antibody Engineering

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Digital Content

RLD : Yes

TE Code : AP

CEFOTETAN DISODIUM

PAI Pharmaceutical Associates

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : CEFOTAN

Dosage Strength : EQ 1GM BASE/VIAL

Approval Date : 1985-12-27

Application Number : 50588

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Product
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08

Brand Name : CEFOTAN

Antibody Engineering

Not Confirmed

Brand Name : CEFOTAN

Antibody Engineering

Not Confirmed

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RLD : Yes

TE Code : AP

CEFOTETAN DISODIUM

PAI Pharmaceutical Associates

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : CEFOTAN

Dosage Strength : EQ 2GM BASE/VIAL

Approval Date : 1985-12-27

Application Number : 50588

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Product
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09

Brand Name : CEFOTAN IN PLASTIC C...

Antibody Engineering

Not Confirmed

Brand Name : CEFOTAN IN PLASTIC C...

Antibody Engineering

Not Confirmed

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RLD : No

TE Code :

CEFOTETAN DISODIUM

PAI Pharmaceutical Associates

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : CEFOTAN IN PLASTIC CONTA...

Dosage Strength : EQ 40MG BASE/ML

Approval Date : 1993-07-30

Application Number : 50694

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

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10

Brand Name : CEFOTAN IN PLASTIC C...

Antibody Engineering

Not Confirmed

Brand Name : CEFOTAN IN PLASTIC C...

Antibody Engineering

Not Confirmed

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Digital Content

RLD : No

TE Code :

CEFOTETAN DISODIUM

PAI Pharmaceutical Associates

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : CEFOTAN IN PLASTIC CONTA...

Dosage Strength : EQ 20MG BASE/ML

Approval Date : 1993-07-30

Application Number : 50694

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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