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DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
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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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Clopidogrel,Aspirin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
New Indication for Plavix® (clopidogrel) Now Approved in the European Union
Details : Plavix (clopidogrel) is a P2Y12 platelet inhibitor which is indicated for the treatment of in adult patients with moderate to high-risk transient ischemic attack.
Product Name : Plavix
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 09, 2021
Lead Product(s) : Bisoprolol Fumarate,Aspirin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Undisclosed
Deal Type : Acquisition
Athena Pharmaceutiques Acquires Bisoprolol + Aspirin Capsules Dossier and Patent
Details : ATHENA Pharmaceutiques has acquire the Bisoprolol + Aspirin Capsules dossier as well as the patent for this product. It is a fixed dose combination of two reference agents improving compliance and adherence to treatment in the secondary prevention of car...
Product Name : Bisoprolol/Aspirin-Generic
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 15, 2021
Lead Product(s) : Aspirin,Clopidogrel,Rosuvastatin Calcium
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr Reddy’s Launches Rozat Gold FDC in India (Aspirin, Rosuvastatin, Clopidogrel)
Details : Rozat Gold is a fixed dose combination medicine consisting aspirin, rosuvastatin & clopidogrel. It is indicated for the treatment of coronary artery diseases.
Product Name : Rozat Gold
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 18, 2021
Lead Product(s) : Paracetamol,Aspirin,Caffeine
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Limited Announces Approval of Acetaminophen, Aspirin and Caffeine Tablets
Details : The US Food & Drug Administration (US FDA) has approved Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).
Product Name : Panodil-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 24, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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REF. STANDARDS & IMPURITIES
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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 Aspro manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aspro, including repackagers and relabelers. The FDA regulates Aspro manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aspro 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 Aspro manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aspro supplier is an individual or a company that provides Aspro active pharmaceutical ingredient (API) or Aspro finished formulations upon request. The Aspro suppliers may include Aspro API manufacturers, exporters, distributors and traders.
click here to find a list of Aspro suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aspro DMF (Drug Master File) is a document detailing the whole manufacturing process of Aspro active pharmaceutical ingredient (API) in detail. Different forms of Aspro DMFs exist exist since differing nations have different regulations, such as Aspro USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aspro DMF submitted to regulatory agencies in the US is known as a USDMF. Aspro USDMF includes data on Aspro's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aspro USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aspro 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 Aspro Drug Master File in Japan (Aspro JDMF) empowers Aspro 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 Aspro JDMF during the approval evaluation for pharmaceutical products. At the time of Aspro 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 Aspro 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 Aspro Drug Master File in Korea (Aspro KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aspro. The MFDS reviews the Aspro KDMF as part of the drug registration process and uses the information provided in the Aspro KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aspro 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 Aspro API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aspro suppliers with KDMF on PharmaCompass.
A Aspro CEP of the European Pharmacopoeia monograph is often referred to as a Aspro Certificate of Suitability (COS). The purpose of a Aspro CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aspro EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aspro to their clients by showing that a Aspro CEP has been issued for it. The manufacturer submits a Aspro CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aspro CEP holder for the record. Additionally, the data presented in the Aspro CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aspro DMF.
A Aspro CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aspro 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 Aspro suppliers with CEP (COS) on PharmaCompass.
A Aspro written confirmation (Aspro WC) is an official document issued by a regulatory agency to a Aspro manufacturer, verifying that the manufacturing facility of a Aspro active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aspro APIs or Aspro finished pharmaceutical products to another nation, regulatory agencies frequently require a Aspro WC (written confirmation) as part of the regulatory process.
click here to find a list of Aspro 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 Aspro as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aspro 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 Aspro 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 Aspro and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aspro NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aspro suppliers with NDC on PharmaCompass.
Aspro 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 Aspro 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 Aspro GMP manufacturer or Aspro GMP API supplier for your needs.
A Aspro CoA (Certificate of Analysis) is a formal document that attests to Aspro's compliance with Aspro specifications and serves as a tool for batch-level quality control.
Aspro CoA mostly includes findings from lab analyses of a specific batch. For each Aspro 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.
Aspro may be tested according to a variety of international standards, such as European Pharmacopoeia (Aspro EP), Aspro JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aspro USP).
