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Axplora- The partner of choice for complex APIs.
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JDMF
NDC
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Basic Nutrition, your expert for sourcing from China, India and Europe.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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NDC
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Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
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Axplora- The partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
Basic Nutrition, your expert for sourcing from China, India and Europe.
About the Company : As an ISO9001, ISO22000 certificated supplier, Basic Nutrition supply high-quality ingredients for nutraceuticals. We can offer a range of products from small to large quantites: h...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Acetylcysteine Zentiva
Dosage Form : Effervescent Tablets
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Acetylcysteine Zentiva
Dosage Form : Effervescent Tablets
Dosage Strength : 600mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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DOSAGE - TABLET, EFFERVESCENT;ORAL - 2.5GM
USFDA APPLICATION NUMBER - 207916
DOSAGE - TABLET, EFFERVESCENT;ORAL - 500MG
USFDA APPLICATION NUMBER - 207916
DOSAGE - INJECTABLE;INTRAVENOUS - 6GM/30ML (2...DOSAGE - INJECTABLE;INTRAVENOUS - 6GM/30ML (200MG/ML)
USFDA APPLICATION NUMBER - 21539
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class D
Dosage Form : Effervescent Tablets
Dosage Strength : 200mg
Price Per Pack (Euro) : 2.84
Published in :
Country : Switzerland
RX/OTC/DISCN : Class D
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class D
Dosage Form : Effervescent Tablets
Dosage Strength : 600mg
Price Per Pack (Euro) : 3.14
Published in :
Country : Switzerland
RX/OTC/DISCN : Class D
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A Acetylcysteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acetylcysteine, including repackagers and relabelers. The FDA regulates Acetylcysteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Acetylcysteine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acetylcysteine supplier is an individual or a company that provides Acetylcysteine active pharmaceutical ingredient (API) or Acetylcysteine finished formulations upon request. The Acetylcysteine suppliers may include Acetylcysteine API manufacturers, exporters, distributors and traders.
click here to find a list of Acetylcysteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acetylcysteine DMF (Drug Master File) is a document detailing the whole manufacturing process of Acetylcysteine active pharmaceutical ingredient (API) in detail. Different forms of Acetylcysteine DMFs exist exist since differing nations have different regulations, such as Acetylcysteine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acetylcysteine DMF submitted to regulatory agencies in the US is known as a USDMF. Acetylcysteine USDMF includes data on Acetylcysteine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acetylcysteine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acetylcysteine suppliers with USDMF on PharmaCompass.
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 Acetylcysteine Drug Master File in Japan (Acetylcysteine JDMF) empowers Acetylcysteine 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 Acetylcysteine JDMF during the approval evaluation for pharmaceutical products. At the time of Acetylcysteine 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 Acetylcysteine suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Acetylcysteine Drug Master File in Korea (Acetylcysteine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acetylcysteine. The MFDS reviews the Acetylcysteine KDMF as part of the drug registration process and uses the information provided in the Acetylcysteine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acetylcysteine 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 Acetylcysteine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Acetylcysteine suppliers with KDMF on PharmaCompass.
A Acetylcysteine CEP of the European Pharmacopoeia monograph is often referred to as a Acetylcysteine Certificate of Suitability (COS). The purpose of a Acetylcysteine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Acetylcysteine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Acetylcysteine to their clients by showing that a Acetylcysteine CEP has been issued for it. The manufacturer submits a Acetylcysteine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Acetylcysteine CEP holder for the record. Additionally, the data presented in the Acetylcysteine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Acetylcysteine DMF.
A Acetylcysteine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acetylcysteine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Acetylcysteine suppliers with CEP (COS) on PharmaCompass.
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 Acetylcysteine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acetylcysteine 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 Acetylcysteine 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 Acetylcysteine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acetylcysteine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acetylcysteine suppliers with NDC on PharmaCompass.
Acetylcysteine 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 Acetylcysteine 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 Acetylcysteine GMP manufacturer or Acetylcysteine GMP API supplier for your needs.
A Acetylcysteine CoA (Certificate of Analysis) is a formal document that attests to Acetylcysteine's compliance with Acetylcysteine specifications and serves as a tool for batch-level quality control.
Acetylcysteine CoA mostly includes findings from lab analyses of a specific batch. For each Acetylcysteine 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.
Acetylcysteine may be tested according to a variety of international standards, such as European Pharmacopoeia (Acetylcysteine EP), Acetylcysteine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acetylcysteine USP).
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