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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Temad- We think of world-class quality.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
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USDMF
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
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API Imports and Exports
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
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Coating Systems & Additives
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Solubilizers
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Disintegrants & Superdisintegrants
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Co-Processed Excipients
Rheology Modifiers
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API Stability Enhancers
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ABOUT THIS PAGE
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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 Acetylsalicylic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acetylsalicylic Acid, including repackagers and relabelers. The FDA regulates Acetylsalicylic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acetylsalicylic Acid 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 Acetylsalicylic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acetylsalicylic Acid supplier is an individual or a company that provides Acetylsalicylic Acid active pharmaceutical ingredient (API) or Acetylsalicylic Acid finished formulations upon request. The Acetylsalicylic Acid suppliers may include Acetylsalicylic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Acetylsalicylic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acetylsalicylic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Acetylsalicylic Acid active pharmaceutical ingredient (API) in detail. Different forms of Acetylsalicylic Acid DMFs exist exist since differing nations have different regulations, such as Acetylsalicylic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acetylsalicylic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Acetylsalicylic Acid USDMF includes data on Acetylsalicylic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acetylsalicylic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acetylsalicylic Acid 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 Acetylsalicylic Acid Drug Master File in Japan (Acetylsalicylic Acid JDMF) empowers Acetylsalicylic Acid 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 Acetylsalicylic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Acetylsalicylic Acid 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 Acetylsalicylic Acid 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 Acetylsalicylic Acid Drug Master File in Korea (Acetylsalicylic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acetylsalicylic Acid. The MFDS reviews the Acetylsalicylic Acid KDMF as part of the drug registration process and uses the information provided in the Acetylsalicylic Acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acetylsalicylic Acid 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 Acetylsalicylic Acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Acetylsalicylic Acid suppliers with KDMF on PharmaCompass.
A Acetylsalicylic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Acetylsalicylic Acid Certificate of Suitability (COS). The purpose of a Acetylsalicylic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Acetylsalicylic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Acetylsalicylic Acid to their clients by showing that a Acetylsalicylic Acid CEP has been issued for it. The manufacturer submits a Acetylsalicylic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Acetylsalicylic Acid CEP holder for the record. Additionally, the data presented in the Acetylsalicylic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Acetylsalicylic Acid DMF.
A Acetylsalicylic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acetylsalicylic Acid 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 Acetylsalicylic Acid suppliers with CEP (COS) on PharmaCompass.
A Acetylsalicylic Acid written confirmation (Acetylsalicylic Acid WC) is an official document issued by a regulatory agency to a Acetylsalicylic Acid manufacturer, verifying that the manufacturing facility of a Acetylsalicylic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acetylsalicylic Acid APIs or Acetylsalicylic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Acetylsalicylic Acid WC (written confirmation) as part of the regulatory process.
click here to find a list of Acetylsalicylic Acid 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 Acetylsalicylic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acetylsalicylic Acid 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 Acetylsalicylic Acid 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 Acetylsalicylic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acetylsalicylic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acetylsalicylic Acid suppliers with NDC on PharmaCompass.
Acetylsalicylic Acid 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 Acetylsalicylic Acid 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 Acetylsalicylic Acid GMP manufacturer or Acetylsalicylic Acid GMP API supplier for your needs.
A Acetylsalicylic Acid CoA (Certificate of Analysis) is a formal document that attests to Acetylsalicylic Acid's compliance with Acetylsalicylic Acid specifications and serves as a tool for batch-level quality control.
Acetylsalicylic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Acetylsalicylic Acid 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.
Acetylsalicylic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Acetylsalicylic Acid EP), Acetylsalicylic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acetylsalicylic Acid USP).
