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List of All Manufacturers & Suppliers of Acetylcysteine Sodium Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 2Sanofi

02 8Aspen Pharmacare Holdings

03 2Athena Pharmaceutiques

04 1Ethypharm

05 3Octavius Pharma Pvt. Ltd

06 1ALMUS Srl

07 2ANGENERICO SpA

08 1Abbott Laboratories

09 2Actor Pharma

10 1Alternova A / S

11 2Alvogen

12 2American Regent

13 1Ampharco USA

14 2Amsa Spa

15 1Angelini Pharma

16 2Arbor Pharmaceuticals

17 6Atabay

18 1Aurobindo Pharma Limited

19 4Austell Laboratories

20 1BIOHEALTH PHARMACEUTICALS Srl

21 2Bristol Myers Squibb

22 2Brooks laboratories Limited

23 1Bruschettini

24 1CUMBERLAND PHARMS

25 1Clinigen Group

26 1Cooper Pharma Limited

27 1DECA LABORATORIO CHIMICO Srl

28 2Dey

29 2EG SpA

30 1EPIFARMA Srl

31 1Eloge

32 2Exela Pharma Sciences, LLC.

33 8Farbe Firma

34 3Farmak JSC

35 1Forrester Pharma

36 1Fresenius Kabi USA

37 1GERMED PLIVA PHARMA SpA

38 2Galephar Pharmaceutical

39 1Gia Nguyen Pharmaceutical

40 1Grupo Azevedos

41 3Grupo Chemo

42 2Ha Noi CPC1 Pharmaceutical JSC

43 2Hexal AG

44 1Hikma Pharmaceuticals

45 4Hospira, Inc.

46 4Humanis

47 2IBSA FARMACEUTICI ITALIA Srl

48 10IBSA Institut Biochimique

49 1Indoco Remedies Limited

50 1Johnson & Johnson

51 4Karo Pharma

52 1Kolmar Korea Co., Ltd.

53 2Laboratorios Basi

54 4Meda - Asker

55 3Meda AB

56 5Mepha Pharma

57 4Nobel Ilac Sanayii Ve Ticaret A.S.

58 1PROGRAMMI SANIT.INTEGRATI Srl

59 2Pharma Dynamics

60 1Phoenix Labs

61 2Quad Pharma

62 1RISING PHARMA

63 4ROXANE

64 2Ratiopharm GmbH

65 1Rising Pharmaceuticals Inc

66 1STERIMAX INC

67 1STERISCIENCE SPECLTS

68 1Sagent Pharmaceuticals

69 20Sandoz B2B

70 3Seoul Pharma Co Ltd

71 1Somerset Pharmaceuticals Inc

72 3Spirig Healthcare

73 1Suncare Formulations

74 1Tactus Nutrasciences

75 1Teva Pharmaceutical Industries

76 2Trinity Pharmaceuticals

77 2Unicorn Pharmaceuticals

78 6Viatris

79 2World Medicine

80 4XL Laboratories Private Limited

81 16Zambon Switzerland

82 1Zim Laboratories

83 1Zydus Pharmaceuticals

84 1iNova Pharmaceuticals

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PharmaCompass

01

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Acetylcystein

Brand Name : Acetylcysteine Zentiva

Dosage Form : Effervescent Tablets

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : ACETYLCYSTEINE

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 6GM/30ML (200MG/ML)

Packaging :

Approval Date : 2022-02-03

Application Number : 213693

Regulatory Info : RX

Registration Country : USA

Aspen API Comapny Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAthena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

Regulatory Info :

Registration Country : France

N-Acetylcysteine

Brand Name :

Dosage Form : Stick Powder

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Athena Company Banner

04

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Acetylcysteine

Brand Name :

Dosage Form : Ampoule

Dosage Strength : 200MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info :

Registration Country : India

Acetylcysteine; Ambroxol Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 200MG; 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

06

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Switzerland

Acetylcystein

Brand Name : Acetylcysteine Zentiva

Dosage Form : Effervescent Tablets

Dosage Strength : 600mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

07

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AAPS 2024
Not Confirmed

Acetylcysteine

Brand Name : Tussmuco

Dosage Form : EFT

Dosage Strength : 200mg

Packaging : 40X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

08

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AAPS 2024
Not Confirmed

Acetylcysteine

Brand Name : Tussmuco

Dosage Form : EFT

Dosage Strength : 200mg

Packaging : 15X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

09

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AAPS 2024
Not Confirmed

Acetylcysteine

Brand Name : Tussmuco

Dosage Form : EFT

Dosage Strength : 200mg

Packaging : 25X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

10

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AAPS 2024
Not Confirmed

N-Acetylcysteine

Brand Name : Parvolex

Dosage Form : INJ

Dosage Strength : 200mg/ml

Packaging : 10X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

11

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AAPS 2024
Not Confirmed

N-Acetylcysteine

Brand Name : Solmucol 200

Dosage Form : SAC

Dosage Strength : 200mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

12

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AAPS 2024
Not Confirmed

N-Acetylcysteine

Brand Name : Solmucol 400

Dosage Form : SAC

Dosage Strength : 400mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

13

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AAPS 2024
Not Confirmed

N-Acetylcysteine

Brand Name : Solmucol Lozenges

Dosage Form : LOZ

Dosage Strength : 100mg

Packaging : 24X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

14

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAthena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

Regulatory Info :

Registration Country : France

N-Acetylcysteine

Brand Name :

Dosage Form : Stick Powder

Dosage Strength : 600MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Athena Company Banner

15

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info :

Registration Country : India

Acetylcysteine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 600MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

16

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info :

Registration Country : India

Acetylcysteine; Ambroxol Hydrochloride

Brand Name :

Dosage Form : Oral Powder

Dosage Strength : 200MG; 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

17

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : MUCOMYST

Dosage Form : SOLUTION;INHALATION, ORAL

Dosage Strength : 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 13601

Regulatory Info : DISCN

Registration Country : USA

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18

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : MUCOMYST

Dosage Form : SOLUTION;INHALATION, ORAL

Dosage Strength : 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 13601

Regulatory Info : DISCN

Registration Country : USA

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19

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE

Brand Name : ACETADOTE

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 6GM/30ML (200MG/ML)

Packaging :

Approval Date : 2004-01-23

Application Number : 21539

Regulatory Info : RX

Registration Country : USA

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20

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE

Brand Name : MUCOMYST W/ ISOPROTERENOL

Dosage Form : SOLUTION;INHALATION

Dosage Strength : 10%;0.05%

Packaging :

Approval Date : 1982-01-01

Application Number : 17366

Regulatory Info : DISCN

Registration Country : USA

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