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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Atropine Sulfate,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Australia Registers First Eye Drops to Slow Short-sightedness Progress in Children
Details : EIKANCE (atropine sulfate monohydrate eye drops) are available on prescription for children aged 4 to 14 years, as a treatment to slow the progression of myopia and may be initiated in children when myopia progresses by 1 or more diopters per year.
Product Name : Eikance
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 18, 2022
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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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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 AtroPen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AtroPen, including repackagers and relabelers. The FDA regulates AtroPen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AtroPen 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 AtroPen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A AtroPen supplier is an individual or a company that provides AtroPen active pharmaceutical ingredient (API) or AtroPen finished formulations upon request. The AtroPen suppliers may include AtroPen API manufacturers, exporters, distributors and traders.
click here to find a list of AtroPen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A AtroPen DMF (Drug Master File) is a document detailing the whole manufacturing process of AtroPen active pharmaceutical ingredient (API) in detail. Different forms of AtroPen DMFs exist exist since differing nations have different regulations, such as AtroPen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AtroPen DMF submitted to regulatory agencies in the US is known as a USDMF. AtroPen USDMF includes data on AtroPen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AtroPen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AtroPen 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 AtroPen Drug Master File in Japan (AtroPen JDMF) empowers AtroPen 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 AtroPen JDMF during the approval evaluation for pharmaceutical products. At the time of AtroPen 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 AtroPen 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 AtroPen Drug Master File in Korea (AtroPen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AtroPen. The MFDS reviews the AtroPen KDMF as part of the drug registration process and uses the information provided in the AtroPen KDMF to evaluate the safety and efficacy of the drug.
After submitting a AtroPen 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 AtroPen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AtroPen suppliers with KDMF on PharmaCompass.
A AtroPen CEP of the European Pharmacopoeia monograph is often referred to as a AtroPen Certificate of Suitability (COS). The purpose of a AtroPen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AtroPen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AtroPen to their clients by showing that a AtroPen CEP has been issued for it. The manufacturer submits a AtroPen CEP (COS) as part of the market authorization procedure, and it takes on the role of a AtroPen CEP holder for the record. Additionally, the data presented in the AtroPen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AtroPen DMF.
A AtroPen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AtroPen 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 AtroPen suppliers with CEP (COS) on PharmaCompass.
A AtroPen written confirmation (AtroPen WC) is an official document issued by a regulatory agency to a AtroPen manufacturer, verifying that the manufacturing facility of a AtroPen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AtroPen APIs or AtroPen finished pharmaceutical products to another nation, regulatory agencies frequently require a AtroPen WC (written confirmation) as part of the regulatory process.
click here to find a list of AtroPen 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 AtroPen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AtroPen 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 AtroPen 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 AtroPen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AtroPen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of AtroPen suppliers with NDC on PharmaCompass.
AtroPen 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 AtroPen GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right AtroPen GMP manufacturer or AtroPen GMP API supplier for your needs.
A AtroPen CoA (Certificate of Analysis) is a formal document that attests to AtroPen's compliance with AtroPen specifications and serves as a tool for batch-level quality control.
AtroPen CoA mostly includes findings from lab analyses of a specific batch. For each AtroPen 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.
AtroPen may be tested according to a variety of international standards, such as European Pharmacopoeia (AtroPen EP), AtroPen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AtroPen USP).
