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API SUPPLIERS
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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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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ABOUT THIS PAGE
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PharmaCompass offers a list of Atropine Sulfate 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 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.
PharmaCompass also assists you with knowing the Atropine Sulfate API Price utilized in the formulation of products. Atropine Sulfate API Price is not always fixed or binding as the Atropine Sulfate Price is obtained through a variety of data sources. The Atropine Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ENLON-PLUS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ENLON-PLUS, including repackagers and relabelers. The FDA regulates ENLON-PLUS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ENLON-PLUS 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 ENLON-PLUS manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ENLON-PLUS supplier is an individual or a company that provides ENLON-PLUS active pharmaceutical ingredient (API) or ENLON-PLUS finished formulations upon request. The ENLON-PLUS suppliers may include ENLON-PLUS API manufacturers, exporters, distributors and traders.
click here to find a list of ENLON-PLUS suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ENLON-PLUS DMF (Drug Master File) is a document detailing the whole manufacturing process of ENLON-PLUS active pharmaceutical ingredient (API) in detail. Different forms of ENLON-PLUS DMFs exist exist since differing nations have different regulations, such as ENLON-PLUS USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ENLON-PLUS DMF submitted to regulatory agencies in the US is known as a USDMF. ENLON-PLUS USDMF includes data on ENLON-PLUS's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ENLON-PLUS USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ENLON-PLUS 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 ENLON-PLUS Drug Master File in Japan (ENLON-PLUS JDMF) empowers ENLON-PLUS 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 ENLON-PLUS JDMF during the approval evaluation for pharmaceutical products. At the time of ENLON-PLUS 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 ENLON-PLUS 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 ENLON-PLUS Drug Master File in Korea (ENLON-PLUS KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ENLON-PLUS. The MFDS reviews the ENLON-PLUS KDMF as part of the drug registration process and uses the information provided in the ENLON-PLUS KDMF to evaluate the safety and efficacy of the drug.
After submitting a ENLON-PLUS 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 ENLON-PLUS API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ENLON-PLUS suppliers with KDMF on PharmaCompass.
A ENLON-PLUS CEP of the European Pharmacopoeia monograph is often referred to as a ENLON-PLUS Certificate of Suitability (COS). The purpose of a ENLON-PLUS CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ENLON-PLUS EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ENLON-PLUS to their clients by showing that a ENLON-PLUS CEP has been issued for it. The manufacturer submits a ENLON-PLUS CEP (COS) as part of the market authorization procedure, and it takes on the role of a ENLON-PLUS CEP holder for the record. Additionally, the data presented in the ENLON-PLUS CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ENLON-PLUS DMF.
A ENLON-PLUS CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ENLON-PLUS 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 ENLON-PLUS suppliers with CEP (COS) on PharmaCompass.
A ENLON-PLUS written confirmation (ENLON-PLUS WC) is an official document issued by a regulatory agency to a ENLON-PLUS manufacturer, verifying that the manufacturing facility of a ENLON-PLUS active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ENLON-PLUS APIs or ENLON-PLUS finished pharmaceutical products to another nation, regulatory agencies frequently require a ENLON-PLUS WC (written confirmation) as part of the regulatory process.
click here to find a list of ENLON-PLUS 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 ENLON-PLUS as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ENLON-PLUS 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 ENLON-PLUS 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 ENLON-PLUS and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ENLON-PLUS NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ENLON-PLUS suppliers with NDC on PharmaCompass.
ENLON-PLUS 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 ENLON-PLUS 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 ENLON-PLUS GMP manufacturer or ENLON-PLUS GMP API supplier for your needs.
A ENLON-PLUS CoA (Certificate of Analysis) is a formal document that attests to ENLON-PLUS's compliance with ENLON-PLUS specifications and serves as a tool for batch-level quality control.
ENLON-PLUS CoA mostly includes findings from lab analyses of a specific batch. For each ENLON-PLUS 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.
ENLON-PLUS may be tested according to a variety of international standards, such as European Pharmacopoeia (ENLON-PLUS EP), ENLON-PLUS JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ENLON-PLUS USP).
