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Looking for 82248-59-7 / Atomoxetin Hydrochloride API manufacturers, exporters & distributors?

Atomoxetin Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Atomoxetin Hydrochloride

Synonyms

Atomoxetine hcl, 82248-59-7, Tomoxetine hydrochloride, Strattera, (r)-tomoxetine hydrochloride, (r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine hydrochloride

Cas Number

82248-59-7

Unique Ingredient Identifier (UNII)

57WVB6I2W0

About Atomoxetin Hydrochloride

A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

Atomoxetin Manufacturers

A Atomoxetin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atomoxetin, including repackagers and relabelers. The FDA regulates Atomoxetin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atomoxetin 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 Atomoxetin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Atomoxetin Suppliers

A Atomoxetin supplier is an individual or a company that provides Atomoxetin active pharmaceutical ingredient (API) or Atomoxetin finished formulations upon request. The Atomoxetin suppliers may include Atomoxetin API manufacturers, exporters, distributors and traders.

click here to find a list of Atomoxetin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Atomoxetin USDMF

A Atomoxetin DMF (Drug Master File) is a document detailing the whole manufacturing process of Atomoxetin active pharmaceutical ingredient (API) in detail. Different forms of Atomoxetin DMFs exist exist since differing nations have different regulations, such as Atomoxetin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Atomoxetin DMF submitted to regulatory agencies in the US is known as a USDMF. Atomoxetin USDMF includes data on Atomoxetin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atomoxetin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Atomoxetin suppliers with USDMF on PharmaCompass.

Atomoxetin JDMF

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 Atomoxetin Drug Master File in Japan (Atomoxetin JDMF) empowers Atomoxetin 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 Atomoxetin JDMF during the approval evaluation for pharmaceutical products. At the time of Atomoxetin 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 Atomoxetin suppliers with JDMF on PharmaCompass.

Atomoxetin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Atomoxetin Drug Master File in Korea (Atomoxetin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atomoxetin. The MFDS reviews the Atomoxetin KDMF as part of the drug registration process and uses the information provided in the Atomoxetin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Atomoxetin 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 Atomoxetin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Atomoxetin suppliers with KDMF on PharmaCompass.

Atomoxetin CEP

A Atomoxetin CEP of the European Pharmacopoeia monograph is often referred to as a Atomoxetin Certificate of Suitability (COS). The purpose of a Atomoxetin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atomoxetin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atomoxetin to their clients by showing that a Atomoxetin CEP has been issued for it. The manufacturer submits a Atomoxetin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atomoxetin CEP holder for the record. Additionally, the data presented in the Atomoxetin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atomoxetin DMF.

A Atomoxetin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atomoxetin 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 Atomoxetin suppliers with CEP (COS) on PharmaCompass.

Atomoxetin WC

A Atomoxetin written confirmation (Atomoxetin WC) is an official document issued by a regulatory agency to a Atomoxetin manufacturer, verifying that the manufacturing facility of a Atomoxetin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atomoxetin APIs or Atomoxetin finished pharmaceutical products to another nation, regulatory agencies frequently require a Atomoxetin WC (written confirmation) as part of the regulatory process.

click here to find a list of Atomoxetin suppliers with Written Confirmation (WC) on PharmaCompass.

Atomoxetin NDC

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 Atomoxetin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Atomoxetin API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Atomoxetin 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Atomoxetin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atomoxetin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Atomoxetin suppliers with NDC on PharmaCompass.

Atomoxetin GMP

Atomoxetin 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 Atomoxetin 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 Atomoxetin GMP manufacturer or Atomoxetin GMP API supplier for your needs.

Atomoxetin CoA

A Atomoxetin CoA (Certificate of Analysis) is a formal document that attests to Atomoxetin's compliance with Atomoxetin specifications and serves as a tool for batch-level quality control.

Atomoxetin CoA mostly includes findings from lab analyses of a specific batch. For each Atomoxetin 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.

Atomoxetin may be tested according to a variety of international standards, such as European Pharmacopoeia (Atomoxetin EP), Atomoxetin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atomoxetin USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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