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List of Drug Master Files (DMF) of Acetylcystein Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Axplora (1)

02 Moehs Iberica (1)

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

04 Fujian South Pharmaceutical (1)

05 Nippon Protein Co Ltd (1)

06 Nippon Rikagaku Yakuhin (1)

07 Waitaki Biosciences (1)

08 Blank (1)

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01 ACETYLCYSTEINE (1)

02 ACETYLCYSTEINE DRUG SUBSTANCE (1)

03 ACETYLCYSTEINE USP (1)

04 ACETYLCYSTEINE, USP (1)

05 N-ACETYL-L-CYSTEINE (4)

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01 China (1)

02 Germany (1)

03 Italy (1)

04 Japan (2)

05 New Zealand (1)

06 Spain (1)

07 Blank (1)

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01 Active (6)

02 Inactive (2)

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01 Complete (3)

02 Blank (5)

5836
Active
1985-03-29
Complete
2014-08-07
2013-04-03
II
Axplora CB

RDD 2024

Not Confirmed

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URL Supplier Web Content
5091
Active
1983-07-04
N/A
II
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URL Supplier Web Content
37947
Active
2023-06-26
Complete
2023-09-18
2023-07-19
II
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URL Supplier Web Content
7816
Inactive
1988-12-15
N/A
II
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URL Supplier Web Content
21789
Active
2008-07-10
N/A
II
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URL Supplier Web Content
3478
Inactive
1979-02-09
N/A
II
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NINGBO ZHENHAI HAIDE BIOTECH CO LTD

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Digital Content Digital Content
URL Supplier Web Content
39018
Active
2023-12-18
N/A
II
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Looking for 616-91-1 / Acetylcysteine API manufacturers, exporters & distributors?

Acetylcysteine manufacturers, exporters & distributors 1

73

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.

Acetylcystein Manufacturers

A Acetylcystein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acetylcystein, including repackagers and relabelers. The FDA regulates Acetylcystein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acetylcystein 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 Acetylcystein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Acetylcystein Suppliers

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

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

Acetylcystein USDMF

A Acetylcystein DMF (Drug Master File) is a document detailing the whole manufacturing process of Acetylcystein active pharmaceutical ingredient (API) in detail. Different forms of Acetylcystein DMFs exist exist since differing nations have different regulations, such as Acetylcystein USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Acetylcystein DMF submitted to regulatory agencies in the US is known as a USDMF. Acetylcystein USDMF includes data on Acetylcystein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acetylcystein USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Acetylcystein suppliers with USDMF on PharmaCompass.

Acetylcystein Manufacturers | Traders | Suppliers

Acetylcystein Manufacturers, Traders, Suppliers 1
15

We have 7 companies offering Acetylcystein

Get in contact with the supplier of your choice:

  1. Axplora
  2. Moehs Iberica
  3. F.I.S. Fabbrica Italiana Sintetici
  4. Fujian South Pharmaceutical
  5. Nippon Protein Co Ltd
  6. Nippon Rikagaku Yakuhin
  7. Waitaki Biosciences
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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