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Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
N-Methyl-3-phenyl-3-hydroxypropylamine
CAS Number : 42142-52-9
End Use API : Atomoxetin Hydrochloride
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
CAS Number : 95-52-3
End Use API : Atomoxetin Hydrochloride
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
N-Methyl-3-phenyl-3-(o-tolyloxy)propylamine hydroc...
CAS Number : 82857-40-7
End Use API : Atomoxetin Hydrochloride
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
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DOSAGE - CAPSULE;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 21411
DOSAGE - CAPSULE;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 21411
DOSAGE - CAPSULE;ORAL - EQ 18MG BASE
USFDA APPLICATION NUMBER - 21411
DOSAGE - CAPSULE;ORAL - EQ 25MG BASE
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
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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 Strattera manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Strattera, including repackagers and relabelers. The FDA regulates Strattera manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Strattera 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 Strattera manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Strattera supplier is an individual or a company that provides Strattera active pharmaceutical ingredient (API) or Strattera finished formulations upon request. The Strattera suppliers may include Strattera API manufacturers, exporters, distributors and traders.
click here to find a list of Strattera suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Strattera DMF (Drug Master File) is a document detailing the whole manufacturing process of Strattera active pharmaceutical ingredient (API) in detail. Different forms of Strattera DMFs exist exist since differing nations have different regulations, such as Strattera USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Strattera DMF submitted to regulatory agencies in the US is known as a USDMF. Strattera USDMF includes data on Strattera's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Strattera USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Strattera 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 Strattera Drug Master File in Japan (Strattera JDMF) empowers Strattera 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 Strattera JDMF during the approval evaluation for pharmaceutical products. At the time of Strattera 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 Strattera 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 Strattera Drug Master File in Korea (Strattera KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Strattera. The MFDS reviews the Strattera KDMF as part of the drug registration process and uses the information provided in the Strattera KDMF to evaluate the safety and efficacy of the drug.
After submitting a Strattera 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 Strattera API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Strattera suppliers with KDMF on PharmaCompass.
A Strattera CEP of the European Pharmacopoeia monograph is often referred to as a Strattera Certificate of Suitability (COS). The purpose of a Strattera CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Strattera EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Strattera to their clients by showing that a Strattera CEP has been issued for it. The manufacturer submits a Strattera CEP (COS) as part of the market authorization procedure, and it takes on the role of a Strattera CEP holder for the record. Additionally, the data presented in the Strattera CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Strattera DMF.
A Strattera CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Strattera 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 Strattera suppliers with CEP (COS) on PharmaCompass.
A Strattera written confirmation (Strattera WC) is an official document issued by a regulatory agency to a Strattera manufacturer, verifying that the manufacturing facility of a Strattera active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Strattera APIs or Strattera finished pharmaceutical products to another nation, regulatory agencies frequently require a Strattera WC (written confirmation) as part of the regulatory process.
click here to find a list of Strattera 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 Strattera as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Strattera 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 Strattera 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 Strattera and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Strattera NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Strattera suppliers with NDC on PharmaCompass.
Strattera 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 Strattera 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 Strattera GMP manufacturer or Strattera GMP API supplier for your needs.
A Strattera CoA (Certificate of Analysis) is a formal document that attests to Strattera's compliance with Strattera specifications and serves as a tool for batch-level quality control.
Strattera CoA mostly includes findings from lab analyses of a specific batch. For each Strattera 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.
Strattera may be tested according to a variety of international standards, such as European Pharmacopoeia (Strattera EP), Strattera JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Strattera USP).
