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EU WC
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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JDMF
NDC
EU, CA, ...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Basic Nutrition, your expert for sourcing from China, India and Europe.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
CEP/COS
NDC
ASMF
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Axplora is your partner of choice for complex APIs.
EU, CA, ...
Axplora is your partner of choice for complex APIs.
EU, CA, ...
Axplora is your partner of choice for complex APIs.
EU, CA, ...
Axplora is your partner of choice for complex APIs.
EU, CA, ...
Axplora is your partner of choice for complex APIs.
EU, CA, ...
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USDMF
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2013-04-03
DMF Number : 5836
Submission : 1985-03-29
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-22
Pay. Date : 2013-01-07
DMF Number : 14304
Submission : 1999-07-21
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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Certificate Number : R2-CEP 1995-028 - Rev 04
Status : Valid
Issue Date : 2020-12-15
Type : Chemical
Substance Number : 967
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : R1-CEP 1996-002 - Rev 06
Status : Valid
Issue Date : 2021-04-16
Type : Chemical
Substance Number : 967
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Axplora is your partner of choice for complex APIs.
Registration Number : 219MF10377
Registrant's Address : ROSENHEIMER STR. 43, D-83064 RAUBLING, GERMARY
Initial Date of Registration : 2007-12-19
Latest Date of Registration : 2007-12-19
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
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API Imports and Exports
Drugs in Development
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Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Ampoule
Dosage Strength : 200MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Acetylcysteine
Dosage Form : Tablet
Dosage Strength : 600MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Acetylcysteine; Ambroxol Hydrochloride
Brand Name : Acetylcysteine; Ambrox...
Dosage Form : Oral Powder
Dosage Strength : 200; 30
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Acetylcysteine; Ambroxol Hydrochloride
Brand Name : Acetylcysteine; Ambrox...
Dosage Form : Tablet
Dosage Strength : 200MG; 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : N-acetyl-cysteine Effe...
Dosage Form : Effervescent Tablet
Dosage Strength : 600MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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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 Neo-fluimucil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neo-fluimucil, including repackagers and relabelers. The FDA regulates Neo-fluimucil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neo-fluimucil 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 Neo-fluimucil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Neo-fluimucil supplier is an individual or a company that provides Neo-fluimucil active pharmaceutical ingredient (API) or Neo-fluimucil finished formulations upon request. The Neo-fluimucil suppliers may include Neo-fluimucil API manufacturers, exporters, distributors and traders.
click here to find a list of Neo-fluimucil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Neo-fluimucil DMF (Drug Master File) is a document detailing the whole manufacturing process of Neo-fluimucil active pharmaceutical ingredient (API) in detail. Different forms of Neo-fluimucil DMFs exist exist since differing nations have different regulations, such as Neo-fluimucil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Neo-fluimucil DMF submitted to regulatory agencies in the US is known as a USDMF. Neo-fluimucil USDMF includes data on Neo-fluimucil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Neo-fluimucil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Neo-fluimucil 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 Neo-fluimucil Drug Master File in Japan (Neo-fluimucil JDMF) empowers Neo-fluimucil 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 Neo-fluimucil JDMF during the approval evaluation for pharmaceutical products. At the time of Neo-fluimucil 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 Neo-fluimucil 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 Neo-fluimucil Drug Master File in Korea (Neo-fluimucil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Neo-fluimucil. The MFDS reviews the Neo-fluimucil KDMF as part of the drug registration process and uses the information provided in the Neo-fluimucil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Neo-fluimucil 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 Neo-fluimucil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Neo-fluimucil suppliers with KDMF on PharmaCompass.
A Neo-fluimucil CEP of the European Pharmacopoeia monograph is often referred to as a Neo-fluimucil Certificate of Suitability (COS). The purpose of a Neo-fluimucil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Neo-fluimucil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Neo-fluimucil to their clients by showing that a Neo-fluimucil CEP has been issued for it. The manufacturer submits a Neo-fluimucil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Neo-fluimucil CEP holder for the record. Additionally, the data presented in the Neo-fluimucil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Neo-fluimucil DMF.
A Neo-fluimucil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Neo-fluimucil 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 Neo-fluimucil 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 Neo-fluimucil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Neo-fluimucil 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 Neo-fluimucil 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 Neo-fluimucil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Neo-fluimucil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Neo-fluimucil suppliers with NDC on PharmaCompass.
Neo-fluimucil 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 Neo-fluimucil 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 Neo-fluimucil GMP manufacturer or Neo-fluimucil GMP API supplier for your needs.
A Neo-fluimucil CoA (Certificate of Analysis) is a formal document that attests to Neo-fluimucil's compliance with Neo-fluimucil specifications and serves as a tool for batch-level quality control.
Neo-fluimucil CoA mostly includes findings from lab analyses of a specific batch. For each Neo-fluimucil 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.
Neo-fluimucil may be tested according to a variety of international standards, such as European Pharmacopoeia (Neo-fluimucil EP), Neo-fluimucil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Neo-fluimucil USP).
