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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Drugs in Development
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DOSAGE - CAPSULE;ORAL - 356.4MG;30MG;16MG
USFDA APPLICATION NUMBER - 11483
DOSAGE - TABLET;ORAL - 325MG;50MG;40MG **Fede...DOSAGE - TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17534
DOSAGE - CAPSULE;ORAL - 325MG;50MG;40MG;30MG
USFDA APPLICATION NUMBER - 19429
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 325MG...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 325MG;40MG
USFDA APPLICATION NUMBER - 205103
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 81MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 81MG;40MG
USFDA APPLICATION NUMBER - 205103
DOSAGE - TABLET;ORAL - 250MG;250MG;65MG
USFDA APPLICATION NUMBER - 20802
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 25M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20884
DOSAGE - TABLET;ORAL - 325MG;50MG;40MG
USFDA APPLICATION NUMBER - 86162
Related Excipient Companies
EUROAPI
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : Castor oil is used as an oily solvent in parenteral dosage forms.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Capsule
Grade : Topical, Oral
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Topical, Oral
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment
Grade : Parenteral, Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Gel
Grade : Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Emulsion
Grade : Parenteral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
12
PharmaCompass offers a list of Aspirin 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 Aspirin manufacturer or Aspirin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aspirin manufacturer or Aspirin supplier.
PharmaCompass also assists you with knowing the Aspirin API Price utilized in the formulation of products. Aspirin API Price is not always fixed or binding as the Aspirin Price is obtained through a variety of data sources. The Aspirin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aspirin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aspirin, including repackagers and relabelers. The FDA regulates Aspirin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aspirin 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 Aspirin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aspirin supplier is an individual or a company that provides Aspirin active pharmaceutical ingredient (API) or Aspirin finished formulations upon request. The Aspirin suppliers may include Aspirin API manufacturers, exporters, distributors and traders.
click here to find a list of Aspirin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aspirin DMF (Drug Master File) is a document detailing the whole manufacturing process of Aspirin active pharmaceutical ingredient (API) in detail. Different forms of Aspirin DMFs exist exist since differing nations have different regulations, such as Aspirin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aspirin DMF submitted to regulatory agencies in the US is known as a USDMF. Aspirin USDMF includes data on Aspirin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aspirin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aspirin 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 Aspirin Drug Master File in Japan (Aspirin JDMF) empowers Aspirin 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 Aspirin JDMF during the approval evaluation for pharmaceutical products. At the time of Aspirin 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 Aspirin 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 Aspirin Drug Master File in Korea (Aspirin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aspirin. The MFDS reviews the Aspirin KDMF as part of the drug registration process and uses the information provided in the Aspirin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aspirin 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 Aspirin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aspirin suppliers with KDMF on PharmaCompass.
A Aspirin CEP of the European Pharmacopoeia monograph is often referred to as a Aspirin Certificate of Suitability (COS). The purpose of a Aspirin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aspirin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aspirin to their clients by showing that a Aspirin CEP has been issued for it. The manufacturer submits a Aspirin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aspirin CEP holder for the record. Additionally, the data presented in the Aspirin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aspirin DMF.
A Aspirin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aspirin 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 Aspirin suppliers with CEP (COS) on PharmaCompass.
A Aspirin written confirmation (Aspirin WC) is an official document issued by a regulatory agency to a Aspirin manufacturer, verifying that the manufacturing facility of a Aspirin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aspirin APIs or Aspirin finished pharmaceutical products to another nation, regulatory agencies frequently require a Aspirin WC (written confirmation) as part of the regulatory process.
click here to find a list of Aspirin 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 Aspirin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aspirin 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 Aspirin 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 Aspirin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aspirin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aspirin suppliers with NDC on PharmaCompass.
Aspirin 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 Aspirin 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 Aspirin GMP manufacturer or Aspirin GMP API supplier for your needs.
A Aspirin CoA (Certificate of Analysis) is a formal document that attests to Aspirin's compliance with Aspirin specifications and serves as a tool for batch-level quality control.
Aspirin CoA mostly includes findings from lab analyses of a specific batch. For each Aspirin 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.
Aspirin may be tested according to a variety of international standards, such as European Pharmacopoeia (Aspirin EP), Aspirin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aspirin USP).
Comment (3)
