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FDF Dossiers

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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

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pharmacompass-1-m-2026-04-20

PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

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Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.

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Padagis

VIRTUAL BOOTH, Contact Details

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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 55 News #PharmaBuzz

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

DEVELOPMENTS

37 Drugs in Development

37 Drugs in Development

FINISHED DOSAGE FORMULATIONS

197 FDF Dossiers, 197 FDA Orange Book

197 FDF Dossiers
197 FDA Orange Book

INSPECTIONS & REGISTRATIONS

17 FDA, 2 GDUFA

17 FDA
2 GDUFA

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FILTER :

filter Active Ingredients Reset all filters

197 All

01 2ACYCLOVIR

02 2ADAPALENE; BENZOYL PEROXIDE

03 1ALBUTEROL SULFATE

04 1AMILORIDE HYDROCHLORIDE

05 2AMMONIUM LACTATE

06 3AZELASTINE HYDROCHLORIDE

07 1AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

08 1BACITRACIN

09 1BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

10 1BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

11 1BACITRACIN ZINC; POLYMYXIN B SULFATE

12 4BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

13 4BETAMETHASONE DIPROPIONATE

14 2BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

15 1BETAMETHASONE VALERATE

16 1BRIMONIDINE TARTRATE

17 1BRINZOLAMIDE

18 1BROMOCRIPTINE MESYLATE

19 1BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

20 2BUDESONIDE

21 2BUTOCONAZOLE NITRATE

22 1CALCIUM ACETATE

23 1CETIRIZINE HYDROCHLORIDE

24 1CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

25 5CICLOPIROX

26 1CLINDAMYCIN PALMITATE HYDROCHLORIDE

27 7CLINDAMYCIN PHOSPHATE

28 5CLOBETASOL PROPIONATE

29 1CLOTRIMAZOLE

30 1CYANOCOBALAMIN

31 1CYCLOSPORINE

32 2DAPSONE

33 2DESONIDE

34 4DESOXIMETASONE

35 1DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

36 1DEXAMETHASONE; TOBRAMYCIN

37 1DIAZEPAM

38 1DICLOFENAC SODIUM

39 1DIHYDROERGOTAMINE MESYLATE

40 1ECONAZOLE NITRATE

41 1EFINACONAZOLE

42 4ERYTHROMYCIN

43 7ESTRADIOL

44 1FLAVOXATE HYDROCHLORIDE

45 3FLUOCINOLONE ACETONIDE

46 2FLUOCINONIDE

47 1FLURANDRENOLIDE

48 3FLUTICASONE PROPIONATE

49 3GENTAMICIN SULFATE

50 1GLYCOPYRRONIUM TOSYLATE

51 4HALOBETASOL PROPIONATE

52 1HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

53 1HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

54 4HYDROCORTISONE

55 1HYDROCORTISONE VALERATE

56 4HYDROMORPHONE HYDROCHLORIDE

57 1IBUPROFEN

58 1IMIQUIMOD

59 2INGENOL MEBUTATE

60 1IVERMECTIN

61 3KETOCONAZOLE

62 1LEVOCETIRIZINE DIHYDROCHLORIDE

63 1LIDOCAINE; PRILOCAINE

64 2LOTEPREDNOL ETABONATE

65 1MESALAMINE

66 1METRONIDAZOLE

67 1MIDAZOLAM HYDROCHLORIDE

68 2MOMETASONE FUROATE

69 1MORPHINE SULFATE

70 2MUPIROCIN

71 1MUPIROCIN CALCIUM

72 2NALOXONE HYDROCHLORIDE

73 2NARATRIPTAN HYDROCHLORIDE

74 1NITROGLYCERIN

75 3NYSTATIN

76 2NYSTATIN; TRIAMCINOLONE ACETONIDE

77 1OLOPATADINE HYDROCHLORIDE

78 1PENCICLOVIR

79 1PERMETHRIN

80 1PILOCARPINE HYDROCHLORIDE

81 2PODOFILOX

82 4POTASSIUM CHLORIDE

83 1PROCHLORPERAZINE

84 2PROMETHAZINE HYDROCHLORIDE

85 3REPAGLINIDE

86 1SCOPOLAMINE

87 1SELENIUM SULFIDE

88 1SUCRALFATE

89 2SULFACETAMIDE SODIUM

90 2SUMATRIPTAN

91 1TAVABOROLE

92 4TAZAROTENE

93 1TERCONAZOLE

94 4TESTOSTERONE

95 1TESTOSTERONE CYPIONATE

96 5TRETINOIN

97 8TRIAMCINOLONE ACETONIDE

98 1TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)

99 2TROSPIUM CHLORIDE

100 2ZOLMITRIPTAN

filter Applicant Reset all filters

197 All

01 92PADAGIS ISRAEL

02 1PADAGIS ISRAEL PHARMA LTD

03 104PADAGIS US

filter Dosage Form Reset all filters

197 All

01 1AEROSOL, FOAM;RECTAL

02 6AEROSOL, FOAM;TOPICAL

03 1AEROSOL, METERED;INHALATION

04 1CAPSULE, DELAYED RELEASE;ORAL

05 3CAPSULE, EXTENDED RELEASE;ORAL

06 1CLOTH;TOPICAL

07 1CREAM, AUGMENTED;TOPICAL

08 28CREAM;TOPICAL

09 5CREAM;VAGINAL

10 1ENEMA;RECTAL

11 1FOR SOLUTION;ORAL

12 1GEL, METERED;TRANSDERMAL

13 23GEL;TOPICAL

14 7GEL;TRANSDERMAL

15 1GEL;VAGINAL

16 3INJECTABLE;INJECTION

17 1LOTION/SHAMPOO;TOPICAL

18 11LOTION;TOPICAL

19 1OIL/DROPS;OTIC

20 2OIL;TOPICAL

21 1OINTMENT, AUGMENTED;TOPICAL

22 7OINTMENT;OPHTHALMIC

23 18OINTMENT;TOPICAL

24 1POWDER;TOPICAL

25 3SHAMPOO;TOPICAL

26 1SOLUTION, METERED;TRANSDERMAL

27 1SOLUTION/DROPS;OPHTHALMIC

28 5SOLUTION;ORAL

29 7SOLUTION;TOPICAL

30 7SPRAY, METERED;NASAL

31 1SPRAY, METERED;SUBLINGUAL

32 5SPRAY;NASAL

33 3SPRAY;TOPICAL

34 1SPRAY;TRANSDERMAL

35 3SUPPOSITORY;RECTAL

36 1SUPPOSITORY;VAGINAL

37 4SUSPENSION/DROPS;OPHTHALMIC

38 2SUSPENSION;ORAL

39 2SUSPENSION;TOPICAL

40 2SWAB;TOPICAL

41 3SYRUP;ORAL

42 1SYSTEM;TRANSDERMAL

43 1Spray

44 6TABLET, EXTENDED RELEASE;ORAL

45 11TABLET;ORAL

46 1TROCHE/LOZENGE;ORAL

filter Dosage Reset all filters

197 All

01 10.005%

02 50.01%

03 10.015%

04 40.025%

05 10.045%

06 210.05%

07 20.064%;0.005%

08 70.1%

09 10.1% (0.25GM/PACKET)

10 10.1% (0.5GM/PACKET)

11 10.1% (0.75GM/PACKET)

12 10.1% (1.25GM/PACKET)

13 10.1% (1GM/PACKET)

14 10.1%;0.3%

15 10.1%;2.5%

16 10.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

17 10.12%

18 10.137MG/SPRAY

19 10.137MG/SPRAY;0.05MG/SPRAY

20 10.147MG/GM

21 20.2%

22 20.2055MG/SPRAY

23 30.25%

24 10.3%;2.5%

25 10.4MG/SPRAY

26 60.5%

27 10.5MG

28 10.5MG/SPRAY

29 10.665MG/SPRAY

30 10.75%

31 30.77%

32 71%

33 11.53MG/SPRAY

34 11.5MG/5ML;5MG/5ML

35 11.62% (20.25MG/1.25GM ACTUATION)

36 11.62% (20.25MG/1.25GM PACKET)

37 11.62% (40.5MG/2.5GM PACKET)

38 310%

39 3100,000 UNITS/GM

40 2100,000 UNITS/GM;0.1%

41 1100MG

42 2100MG/5ML

43 210MEQ

44 110MG

45 110MG/1SPRAY

46 112.5MG

47 112MG

48 116MG

49 11GM/10ML

50 11MG

51 11MG/72HR

52 11MG/ML

53 102%

54 42.5%

55 12.5%;2.5%

56 12.5%;EQ 1.2% BASE

57 12.5MG/5ML

58 12.5MG/SPRAY

59 1200MG/ML

60 120MG

61 120MG/SPRAY

62 225MG

63 12MG

64 12MG/5ML;10MG/5ML;30MG/5ML

65 12MG/ACTUATION

66 13%

67 13.7%;2.86%;3.42%

68 13.75%;EQ 1.2% BASE

69 130MG/1.5ML ACTUATION

70 132MG

71 13MG

72 1400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

73 1400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

74 14GM/60ML

75 14MG/5ML;5MG/5ML;60MG/5ML

76 14MG/SPRAY

77 65%

78 15%;1.2%

79 15%;EQ 1% BASE

80 1500 UNITS/GM

81 1500 UNITS/GM;10,000 UNITS/GM

82 150MG/ML

83 25MG

84 15MG/5ML

85 15MG/5ML;60MG/5ML

86 25MG/SPRAY

87 160MG

88 1667MG

89 17.5%

90 18%

91 180MG

92 28MEQ

93 18MG

94 18MG/SPRAY

95 4EQ 0.05% BASE

96 1EQ 0.09MG BASE/INH

97 2EQ 0.1% BASE

98 1EQ 0.3% BASE

99 1EQ 0.33% BASE

100 5EQ 1% BASE

101 2EQ 12% BASE

102 1EQ 1MG BASE

103 2EQ 2% BASE

104 1EQ 2.4% BASE

105 2EQ 2.5MG BASE

106 1EQ 2MG BASE/ML

107 1EQ 75MG BASE/5ML

filter Country Reset all filters

197 All

01 197USA

List of Suppliers

Supplier Virtual Booth

price-trend

01

Brand Name : ACYCLOVIR

AMWC Asia-TDAC

Not Confirmed

Brand Name : ACYCLOVIR

AMWC Asia-TDAC

Not Confirmed

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Regulatory Info : DISCN

Registration Country : USA

Dosage Form : OINTMENT;TOPICAL

Brand Name : ACYCLOVIR

Dosage Strength : 5%

Packaging :

Approval Date : 2019-02-20

Application Number : 205659

Regulatory Info : DISCN

Registration Country : USA

Product
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02

Brand Name : ACYCLOVIR

AMWC Asia-TDAC

Not Confirmed

Brand Name : ACYCLOVIR

AMWC Asia-TDAC

Not Confirmed

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Regulatory Info : RX

Registration Country : USA

Dosage Form : CREAM;TOPICAL

Brand Name : ACYCLOVIR

Dosage Strength : 5%

Packaging :

Approval Date : 2019-02-04

Application Number : 208702

Regulatory Info : RX

Registration Country : USA

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03

Brand Name : ADAPALENE AND BENZOY...

AMWC Asia-TDAC

Not Confirmed

Brand Name : ADAPALENE AND BENZOY...

AMWC Asia-TDAC

Not Confirmed

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Regulatory Info : RX

Registration Country : USA

ADAPALENE; BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Brand Name : ADAPALENE AND BENZOYL PER...

Dosage Strength : 0.1%;2.5%

Packaging :

Approval Date : 2018-01-23

Application Number : 205033

Regulatory Info : RX

Registration Country : USA

Product
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04

Brand Name : ADAPALENE AND BENZOY...

AMWC Asia-TDAC

Not Confirmed

Brand Name : ADAPALENE AND BENZOY...

AMWC Asia-TDAC

Not Confirmed

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Regulatory Info : RX

Registration Country : USA

ADAPALENE; BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Brand Name : ADAPALENE AND BENZOYL PER...

Dosage Strength : 0.3%;2.5%

Packaging :

Approval Date : 2022-05-31

Application Number : 212464

Regulatory Info : RX

Registration Country : USA

Product
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05

Brand Name : ALBUTEROL SULFATE

AMWC Asia-TDAC

Not Confirmed

Brand Name : ALBUTEROL SULFATE

AMWC Asia-TDAC

Not Confirmed

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Regulatory Info : RX

Registration Country : USA

ALBUTEROL SULFATE

Dosage Form : AEROSOL, METERED;INHALAT...

Brand Name : ALBUTEROL SULFATE

Dosage Strength : EQ 0.09MG BASE/INH

Packaging :

Approval Date : 2020-02-24

Application Number : 203760

Regulatory Info : RX

Registration Country : USA

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06

Brand Name : MIDAMOR

AMWC Asia-TDAC

Not Confirmed

Brand Name : MIDAMOR

AMWC Asia-TDAC

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Regulatory Info : RX

Registration Country : USA

AMILORIDE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Brand Name : MIDAMOR

Dosage Strength : 5MG

Packaging :

Approval Date : 1982-01-01

Application Number : 18200

Regulatory Info : RX

Registration Country : USA

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07

Brand Name : AMMONIUM LACTATE

AMWC Asia-TDAC

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Brand Name : AMMONIUM LACTATE

AMWC Asia-TDAC

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Regulatory Info : RX

Registration Country : USA

AMMONIUM LACTATE

Dosage Form : LOTION;TOPICAL

Brand Name : AMMONIUM LACTATE

Dosage Strength : EQ 12% BASE

Packaging :

Approval Date : 2004-06-23

Application Number : 75570

Regulatory Info : RX

Registration Country : USA

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08

Brand Name : AMMONIUM LACTATE

AMWC Asia-TDAC

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Brand Name : AMMONIUM LACTATE

AMWC Asia-TDAC

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Regulatory Info : RX

Registration Country : USA

AMMONIUM LACTATE

Dosage Form : CREAM;TOPICAL

Brand Name : AMMONIUM LACTATE

Dosage Strength : EQ 12% BASE

Packaging :

Approval Date : 2002-05-01

Application Number : 75774

Regulatory Info : RX

Registration Country : USA

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09

Brand Name : AZELASTINE HYDROCHLO...

AMWC Asia-TDAC

Not Confirmed

Brand Name : AZELASTINE HYDROCHLO...

AMWC Asia-TDAC

Not Confirmed

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Regulatory Info : DISCN

Registration Country : USA

AZELASTINE HYDROCHLORIDE

Dosage Form : SPRAY, METERED;NASAL

Brand Name : AZELASTINE HYDROCHLORIDE

Dosage Strength : 0.137MG/SPRAY

Packaging :

Approval Date : 2017-03-17

Application Number : 202609

Regulatory Info : DISCN

Registration Country : USA

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10

Brand Name : AZELASTINE HYDROCHLO...

AMWC Asia-TDAC

Not Confirmed

Brand Name : AZELASTINE HYDROCHLO...

AMWC Asia-TDAC

Not Confirmed

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Regulatory Info : DISCN

Registration Country : USA

AZELASTINE HYDROCHLORIDE

Dosage Form : SPRAY, METERED;NASAL

Brand Name : AZELASTINE HYDROCHLORIDE

Dosage Strength : 0.2055MG/SPRAY

Packaging :

Approval Date : 2014-05-08

Application Number : 202743

Regulatory Info : DISCN

Registration Country : USA

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.