Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
CEP/COS 
EU-WC
NDC
CN, RU, ...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
CDMF
Jai Radhe Sales is your partner for all your sourcing needs.
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
CEP/COS
JDMF
NDC
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USDMF
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
About the Company : Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of products, including APIs...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
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 Economic Development...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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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 ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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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
Related Excipient Companies
SPI Pharma
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Thickeners and Stabilizers
Coating Systems & Additives
Empty Capsules
Direct Compression
Taste Masking
Topical
Lubricants & Glidants
Co-Processed Excipients
Film Formers & Plasticizers
Granulation
Coloring Agents
Emulsifying Agents
Chewable & Orodispersible Aids
Disintegrants & Superdisintegrants
Solubilizers
Rheology Modifiers
Controlled & Modified Release
Parenteral
API Stability Enhancers
Surfactant & Foaming Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
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 Atomoxetin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atomoxetin Hydrochloride, including repackagers and relabelers. The FDA regulates Atomoxetin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atomoxetin 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 Atomoxetin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atomoxetin Hydrochloride supplier is an individual or a company that provides Atomoxetin Hydrochloride active pharmaceutical ingredient (API) or Atomoxetin Hydrochloride finished formulations upon request. The Atomoxetin Hydrochloride suppliers may include Atomoxetin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Atomoxetin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Atomoxetin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Atomoxetin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Atomoxetin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Atomoxetin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atomoxetin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Atomoxetin Hydrochloride USDMF includes data on Atomoxetin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atomoxetin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atomoxetin 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 Atomoxetin Hydrochloride Drug Master File in Japan (Atomoxetin Hydrochloride JDMF) empowers Atomoxetin 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 Atomoxetin Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Atomoxetin 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 Atomoxetin 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 Atomoxetin Hydrochloride Drug Master File in Korea (Atomoxetin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atomoxetin Hydrochloride. The MFDS reviews the Atomoxetin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Atomoxetin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atomoxetin 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 Atomoxetin Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atomoxetin Hydrochloride suppliers with KDMF on PharmaCompass.
A Atomoxetin Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Atomoxetin Hydrochloride Certificate of Suitability (COS). The purpose of a Atomoxetin Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atomoxetin Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atomoxetin Hydrochloride to their clients by showing that a Atomoxetin Hydrochloride CEP has been issued for it. The manufacturer submits a Atomoxetin Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atomoxetin Hydrochloride CEP holder for the record. Additionally, the data presented in the Atomoxetin Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atomoxetin Hydrochloride DMF.
A Atomoxetin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atomoxetin 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 Atomoxetin Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Atomoxetin Hydrochloride written confirmation (Atomoxetin Hydrochloride WC) is an official document issued by a regulatory agency to a Atomoxetin Hydrochloride manufacturer, verifying that the manufacturing facility of a Atomoxetin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atomoxetin Hydrochloride APIs or Atomoxetin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Atomoxetin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Atomoxetin 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 Atomoxetin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Atomoxetin 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 Atomoxetin 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 Atomoxetin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atomoxetin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Atomoxetin Hydrochloride suppliers with NDC on PharmaCompass.
Atomoxetin 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 Atomoxetin 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 Atomoxetin Hydrochloride GMP manufacturer or Atomoxetin Hydrochloride GMP API supplier for your needs.
A Atomoxetin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Atomoxetin Hydrochloride's compliance with Atomoxetin Hydrochloride specifications and serves as a tool for batch-level quality control.
Atomoxetin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Atomoxetin 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.
Atomoxetin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Atomoxetin Hydrochloride EP), Atomoxetin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atomoxetin Hydrochloride USP).
