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List of all Manufacturers, Suppliers & Exporters of N-Acetylcysteine API listed on PharmaCompass with details of regulatory filings

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01 Axplora (1)

02 Basic Nutrition (1)

03 Transo-Pharm Handels GmbH (1)

04 ZACH System SA (1)

05 Moehs Iberica (1)

06 Pharm-RX Chemical (1)

07 Amara Labs (1)

08 Arevipharma (1)

09 Arudavis Labs (1)

10 Biotechnica DWC (1)

11 F.I.S. Fabbrica Italiana Sintetici (1)

12 Fujian South Pharmaceutical (1)

13 Hunan Warrant Chiral Pharmaceutical (1)

14 Jing Jing Pharmaceutical (1)

15 Nippon Protein Co Ltd (3)

16 Nippon Rikagaku Yakuhin (2)

17 Protchem Industries India Ltd (1)

18 Seven Star Pharmaceutical (1)

19 Summit Ingredients (1)

20 Summit Pharmaceuticals Europe Srl (1)

21 Waitaki Biosciences (1)

22 Wuhan Grand Hoyo Co., Ltd. (2)

23 Yangzhou Gami Biochem Co. Ltd (1)

24 Blank (1)

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01 Algeria (1)

02 China (8)

03 France (1)

04 Germany (3)

05 India (3)

06 Italy (2)

07 Japan (5)

08 New Zealand (1)

09 Spain (1)

10 Taiwan (1)

11 U.S.A (1)

12 Blank (1)

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01 Active (6)

02 Inactive (2)

03 Blank (20)

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01 Expired (1)

02 Valid (9)

03 Withdrawn by Holder (1)

04 Blank (17)

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01 217MF10061 (1)

02 218MF10577 (1)

03 219MF10377 (1)

04 220MF10106 (1)

05 224MF10007 (1)

06 224MF10025 (1)

07 Blank (22)

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01 Blank (28)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
5836
R2-CEP 1995-028 - Rev 04
219MF10377
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
N-ACETYL-L-CYSTEINE
Acetylcysteine
Acetylcysteine at ROSENHEIMER STR. ...
Issue/Submission Date
1985-03-29
2020-12-15
2007-12-19
Axplora CB

2024 ACI Convention

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
Basic Nutrition Company Banner

2024 ACI Convention

Not Confirmed

envelop Contact Supplier
NA Not Available For Sales
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
R1-CEP 2016-311 - Rev 00
Status
Valid
 
Filing Details
Acetylcysteine
Issue/Submission Date
2022-02-07
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
14304
R1-CEP 1996-002 - Rev 06
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ACETYLCYSTEINE USP
Acetylcysteine
Issue/Submission Date
1999-07-21
2021-04-16
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Pharm RX

2024 ACI Convention

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
5091
R1-CEP 1996-070 - Rev 09
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
ACETYLCYSTEINE, USP
Acetylcysteine
Issue/Submission Date
1983-07-04
2021-07-23
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USDMF

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CEP/COS

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Japanese DMF

Found JDMF

Written Confirmation

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Application Number
21789
R1-CEP 1998-098 - Rev 02
224MF10025
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
ACETYLCYSTEINE DRUG SUBSTANCE
Acetylcysteine
Japanese Pharmacopoeia-acetyl-cyste...
Issue/Submission Date
2008-07-10
2009-05-20
2012-02-01
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
37947
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
ACETYLCYSTEINE
Issue/Submission Date
2023-06-26
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USDMF

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Application Number
3478
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
N-ACETYL-L-CYSTEINE
Issue/Submission Date
1979-02-09
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
7816
R1-CEP 1996-080 - Rev 04
224MF10007
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
N-ACETYL-L-CYSTEINE
Acetylcysteine
Japanese Pharmacopoeia-acetylcystei...
Issue/Submission Date
1988-12-15
2020-06-19
2012-01-18
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USDMF

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CEP/COS

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Application Number
220MF10106
Status
 
Filing Details
Outsiders regulations acetylcystein...
Issue/Submission Date
2008-04-11
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USDMF

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CEP/COS

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Application Number
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USDMF

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USDMF

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CEP/COS

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Japanese DMF

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Application Number
R0-CEP 2022-177 - Rev 00
Status
Valid
 
Filing Details
Acetylcysteine
Issue/Submission Date
2023-08-29
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USDMF

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Application Number
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USDMF

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Written Confirmation

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Application Number
R1-CEP 2010-092 - Rev 02
Status
Valid
 
Filing Details
Acetylcysteine
Issue/Submission Date
2021-02-02
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USDMF

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Application Number
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USDMF

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Application Number
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Issue/Submission Date
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USDMF

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Application Number
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USDMF

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Application Number
R0-CEP 2002-122 - Rev 01
Status
Expired
 
Filing Details
Acetylcysteine
Issue/Submission Date
2004-11-29
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USDMF

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CEP/COS

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Application Number
218MF10577
Status
 
Filing Details
Outsiders regulations acetylcystein...
Issue/Submission Date
2006-06-15
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USDMF

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USDMF

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USDMF

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Application Number
217MF10061
Status
 
Filing Details
Outsiders regulations acetylcystein...
Issue/Submission Date
2005-05-20
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USDMF

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Application Number
R0-CEP 2022-064 - Rev 00
Status
Valid
 
Filing Details
Acetylcysteine
Issue/Submission Date
2022-05-23
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USDMF

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Application Number
R1-CEP 2005-018 - Rev 00
Status
Withdrawn by Holder
 
Filing Details
Acetylcysteine
Issue/Submission Date
2011-04-20
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USDMF

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Application Number
39018
Status
Active
Fees Unpaid
N/A
 
Filing Details
N-ACETYL-L-CYSTEINE
Issue/Submission Date
2023-12-18
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Looking for 616-91-1 / Acetylcysteine API manufacturers, exporters & distributors?

Acetylcysteine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Acetylcysteine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Acetylcysteine manufacturer or Acetylcysteine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acetylcysteine manufacturer or Acetylcysteine supplier.

PharmaCompass also assists you with knowing the Acetylcysteine API Price utilized in the formulation of products. Acetylcysteine API Price is not always fixed or binding as the Acetylcysteine Price is obtained through a variety of data sources. The Acetylcysteine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Acetylcysteine

Synonyms

N-acetyl-l-cysteine, 616-91-1, N-acetylcysteine, Mercapturic acid, Acetadote, Broncholysin

Cas Number

616-91-1

Unique Ingredient Identifier (UNII)

WYQ7N0BPYC

About Acetylcysteine

The N-acetyl derivative of CYSTEINE. It is used as a mucolytic agent to reduce the viscosity of mucous secretions. It has also been shown to have antiviral effects in patients with HIV due to inhibition of viral stimulation by reactive oxygen intermediates.

N-Acetylcysteine Manufacturers

A N-Acetylcysteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Acetylcysteine, including repackagers and relabelers. The FDA regulates N-Acetylcysteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Acetylcysteine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of N-Acetylcysteine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

N-Acetylcysteine Suppliers

A N-Acetylcysteine supplier is an individual or a company that provides N-Acetylcysteine active pharmaceutical ingredient (API) or N-Acetylcysteine finished formulations upon request. The N-Acetylcysteine suppliers may include N-Acetylcysteine API manufacturers, exporters, distributors and traders.

click here to find a list of N-Acetylcysteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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