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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 21411
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USFDA APPLICATION NUMBER - 21411
DOSAGE - CAPSULE;ORAL - EQ 18MG BASE
USFDA APPLICATION NUMBER - 21411
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USFDA APPLICATION NUMBER - 21411
DOSAGE - CAPSULE;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 21411
DOSAGE - CAPSULE;ORAL - EQ 60MG BASE
USFDA APPLICATION NUMBER - 21411
DOSAGE - CAPSULE;ORAL - EQ 80MG BASE
USFDA APPLICATION NUMBER - 21411
Related Excipient Companies
SPI Pharma
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
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PharmaCompass offers a list of Atomoxetin Hydrochloride 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 Atomoxetin Hydrochloride manufacturer or Atomoxetin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Atomoxetin Hydrochloride manufacturer or Atomoxetin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Atomoxetin Hydrochloride API Price utilized in the formulation of products. Atomoxetin Hydrochloride API Price is not always fixed or binding as the Atomoxetin Hydrochloride Price is obtained through a variety of data sources. The Atomoxetin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Atomoxetine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atomoxetine Hydrochloride, including repackagers and relabelers. The FDA regulates Atomoxetine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atomoxetine Hydrochloride supplier is an individual or a company that provides Atomoxetine Hydrochloride active pharmaceutical ingredient (API) or Atomoxetine Hydrochloride finished formulations upon request. The Atomoxetine Hydrochloride suppliers may include Atomoxetine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Atomoxetine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Atomoxetine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Atomoxetine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Atomoxetine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Atomoxetine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atomoxetine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Atomoxetine Hydrochloride USDMF includes data on Atomoxetine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atomoxetine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride Drug Master File in Japan (Atomoxetine Hydrochloride JDMF) empowers Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride Drug Master File in Korea (Atomoxetine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atomoxetine Hydrochloride. The MFDS reviews the Atomoxetine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Atomoxetine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atomoxetine Hydrochloride suppliers with KDMF on PharmaCompass.
A Atomoxetine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Atomoxetine Hydrochloride Certificate of Suitability (COS). The purpose of a Atomoxetine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atomoxetine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atomoxetine Hydrochloride to their clients by showing that a Atomoxetine Hydrochloride CEP has been issued for it. The manufacturer submits a Atomoxetine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atomoxetine Hydrochloride CEP holder for the record. Additionally, the data presented in the Atomoxetine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atomoxetine Hydrochloride DMF.
A Atomoxetine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Atomoxetine Hydrochloride written confirmation (Atomoxetine Hydrochloride WC) is an official document issued by a regulatory agency to a Atomoxetine Hydrochloride manufacturer, verifying that the manufacturing facility of a Atomoxetine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atomoxetine Hydrochloride APIs or Atomoxetine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Atomoxetine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atomoxetine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Atomoxetine Hydrochloride suppliers with NDC on PharmaCompass.
Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride GMP manufacturer or Atomoxetine Hydrochloride GMP API supplier for your needs.
A Atomoxetine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Atomoxetine Hydrochloride's compliance with Atomoxetine Hydrochloride specifications and serves as a tool for batch-level quality control.
Atomoxetine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Atomoxetine Hydrochloride 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.
Atomoxetine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Atomoxetine Hydrochloride EP), Atomoxetine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atomoxetine Hydrochloride USP).
