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List of Drug Master Files (JDMF) for N-Acetyl-L-(+)-cysteine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 PharmaZell GmbH (1)

02 Nippon Protein Co., Ltd. (3)

03 Nippon Rikagaku Yakuhin Co., Ltd. (2)

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01 Acetylcysteine (1)

02 Japanese Pharmacopoeia-acetyl-cysteine (1)

03 Japanese Pharmacopoeia-acetylcysteine ​​"production-only" (1)

04 Outsiders regulations acetylcysteine (1)

05 Outsiders regulations acetylcysteine ​​(production only) (2)

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01 Germany (1)

02 Japan (5)

219MF10377
ROSENHEIMER STR. 43, D-83064 RAUBLI...
2007-12-19
2007-12-19
Axplora CB

RDD 2024

Not Confirmed

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220MF10106
575-1 Shimadacho, Ashikaga City, To...
2008-04-11
2008-04-11
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218MF10577
575-1 Shimadacho, Ashikaga City, To...
2006-06-15
2006-06-15
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224MF10007
575-1 Shimadacho, Ashikaga City, To...
2012-01-18
2012-01-18
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217MF10061
4-2-2 Nihonbashi Honmachi, Chuo-ku,...
2006-05-18
2005-05-20
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224MF10025
4-2-2 Nihonbashi Honmachi, Chuo-ku,...
2012-02-01
2012-02-01
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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-Acetyl-L-(+)-cysteine Manufacturers

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

N-Acetyl-L-(+)-cysteine Suppliers

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

click here to find a list of N-Acetyl-L-(+)-cysteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

N-Acetyl-L-(+)-cysteine JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The N-Acetyl-L-(+)-cysteine Drug Master File in Japan (N-Acetyl-L-(+)-cysteine JDMF) empowers N-Acetyl-L-(+)-cysteine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the N-Acetyl-L-(+)-cysteine JDMF during the approval evaluation for pharmaceutical products. At the time of N-Acetyl-L-(+)-cysteine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of N-Acetyl-L-(+)-cysteine suppliers with JDMF on PharmaCompass.

N-Acetyl-L-(+)-cysteine Manufacturers | Traders | Suppliers

N-Acetyl-L-(+)-cysteine Manufacturers, Traders, Suppliers 1
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We have 3 companies offering N-Acetyl-L-(+)-cysteine

Get in contact with the supplier of your choice:

  1. Axplora
  2. Nippon Protein Co Ltd
  3. Nippon Rikagaku Yakuhin
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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