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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 0.025MG;2.5MG
USFDA APPLICATION NUMBER - 12462
DOSAGE - INJECTABLE;INJECTION - 0.14MG/ML;10M...DOSAGE - INJECTABLE;INJECTION - 0.14MG/ML;10MG/ML
USFDA APPLICATION NUMBER - 19678
DOSAGE - SOLUTION;INTRAVENOUS - 0.25MG/5ML (0...DOSAGE - SOLUTION;INTRAVENOUS - 0.25MG/5ML (0.05MG/ML)
USFDA APPLICATION NUMBER - 21146
DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0....DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0.1MG/ML)
USFDA APPLICATION NUMBER - 21146
DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1...DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1MG/ML)
USFDA APPLICATION NUMBER - 21146
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EUROAPI
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
27
PharmaCompass offers a list of Atropine Sulfate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Atropine Sulfate manufacturer or Atropine Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Atropine Sulfate manufacturer or Atropine Sulfate supplier.
A MOTOFEN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MOTOFEN, including repackagers and relabelers. The FDA regulates MOTOFEN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MOTOFEN 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 MOTOFEN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A MOTOFEN supplier is an individual or a company that provides MOTOFEN active pharmaceutical ingredient (API) or MOTOFEN finished formulations upon request. The MOTOFEN suppliers may include MOTOFEN API manufacturers, exporters, distributors and traders.
click here to find a list of MOTOFEN suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A MOTOFEN DMF (Drug Master File) is a document detailing the whole manufacturing process of MOTOFEN active pharmaceutical ingredient (API) in detail. Different forms of MOTOFEN DMFs exist exist since differing nations have different regulations, such as MOTOFEN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MOTOFEN DMF submitted to regulatory agencies in the US is known as a USDMF. MOTOFEN USDMF includes data on MOTOFEN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MOTOFEN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MOTOFEN 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 MOTOFEN Drug Master File in Japan (MOTOFEN JDMF) empowers MOTOFEN 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 MOTOFEN JDMF during the approval evaluation for pharmaceutical products. At the time of MOTOFEN 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 MOTOFEN 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 MOTOFEN Drug Master File in Korea (MOTOFEN KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MOTOFEN. The MFDS reviews the MOTOFEN KDMF as part of the drug registration process and uses the information provided in the MOTOFEN KDMF to evaluate the safety and efficacy of the drug.
After submitting a MOTOFEN 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 MOTOFEN API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MOTOFEN suppliers with KDMF on PharmaCompass.
A MOTOFEN CEP of the European Pharmacopoeia monograph is often referred to as a MOTOFEN Certificate of Suitability (COS). The purpose of a MOTOFEN CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MOTOFEN EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MOTOFEN to their clients by showing that a MOTOFEN CEP has been issued for it. The manufacturer submits a MOTOFEN CEP (COS) as part of the market authorization procedure, and it takes on the role of a MOTOFEN CEP holder for the record. Additionally, the data presented in the MOTOFEN CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MOTOFEN DMF.
A MOTOFEN CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MOTOFEN 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 MOTOFEN suppliers with CEP (COS) on PharmaCompass.
A MOTOFEN written confirmation (MOTOFEN WC) is an official document issued by a regulatory agency to a MOTOFEN manufacturer, verifying that the manufacturing facility of a MOTOFEN active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MOTOFEN APIs or MOTOFEN finished pharmaceutical products to another nation, regulatory agencies frequently require a MOTOFEN WC (written confirmation) as part of the regulatory process.
click here to find a list of MOTOFEN suppliers with Written Confirmation (WC) 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 MOTOFEN as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MOTOFEN 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 MOTOFEN 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 MOTOFEN and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MOTOFEN NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MOTOFEN suppliers with NDC on PharmaCompass.
MOTOFEN 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 MOTOFEN GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right MOTOFEN GMP manufacturer or MOTOFEN GMP API supplier for your needs.
A MOTOFEN CoA (Certificate of Analysis) is a formal document that attests to MOTOFEN's compliance with MOTOFEN specifications and serves as a tool for batch-level quality control.
MOTOFEN CoA mostly includes findings from lab analyses of a specific batch. For each MOTOFEN 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.
MOTOFEN may be tested according to a variety of international standards, such as European Pharmacopoeia (MOTOFEN EP), MOTOFEN JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MOTOFEN USP).
