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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.
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.
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.
A N Acetyl L cysteine DMF (Drug Master File) is a document detailing the whole manufacturing process of N Acetyl L cysteine active pharmaceutical ingredient (API) in detail. Different forms of N Acetyl L cysteine DMFs exist exist since differing nations have different regulations, such as N Acetyl L cysteine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N Acetyl L cysteine DMF submitted to regulatory agencies in the US is known as a USDMF. N Acetyl L cysteine USDMF includes data on N Acetyl L cysteine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N Acetyl L cysteine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a N Acetyl L cysteine Drug Master File in Korea (N Acetyl L cysteine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of N Acetyl L cysteine. The MFDS reviews the N Acetyl L cysteine KDMF as part of the drug registration process and uses the information provided in the N Acetyl L cysteine KDMF to evaluate the safety and efficacy of the drug.
After submitting a N Acetyl L cysteine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their N Acetyl L cysteine API can apply through the Korea Drug Master File (KDMF).
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A N Acetyl L cysteine CEP of the European Pharmacopoeia monograph is often referred to as a N Acetyl L cysteine Certificate of Suitability (COS). The purpose of a N Acetyl L cysteine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of N Acetyl L cysteine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of N Acetyl L cysteine to their clients by showing that a N Acetyl L cysteine CEP has been issued for it. The manufacturer submits a N Acetyl L cysteine CEP (COS) as part of the market authorization procedure, and it takes on the role of a N Acetyl L cysteine CEP holder for the record. Additionally, the data presented in the N Acetyl L cysteine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the N Acetyl L cysteine DMF.
A N Acetyl L cysteine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. N Acetyl L cysteine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing N Acetyl L cysteine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for N Acetyl L cysteine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture N Acetyl L cysteine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain N Acetyl L cysteine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a N Acetyl L cysteine NDC to their finished compounded human drug products, they may choose to do so.
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N Acetyl L cysteine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of N Acetyl L cysteine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right N Acetyl L cysteine GMP manufacturer or N Acetyl L cysteine GMP API supplier for your needs.
A N Acetyl L cysteine CoA (Certificate of Analysis) is a formal document that attests to N Acetyl L cysteine's compliance with N Acetyl L cysteine specifications and serves as a tool for batch-level quality control.
N Acetyl L cysteine CoA mostly includes findings from lab analyses of a specific batch. For each N Acetyl L cysteine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
N Acetyl L cysteine may be tested according to a variety of international standards, such as European Pharmacopoeia (N Acetyl L cysteine EP), N Acetyl L cysteine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (N Acetyl L cysteine USP).