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PharmaCompass offers a list of Aminophylline 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 Aminophylline manufacturer or Aminophylline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aminophylline manufacturer or Aminophylline supplier.
PharmaCompass also assists you with knowing the Aminophylline API Price utilized in the formulation of products. Aminophylline API Price is not always fixed or binding as the Aminophylline Price is obtained through a variety of data sources. The Aminophylline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aminophylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aminophylline, including repackagers and relabelers. The FDA regulates Aminophylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aminophylline 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 Aminophylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aminophylline supplier is an individual or a company that provides Aminophylline active pharmaceutical ingredient (API) or Aminophylline finished formulations upon request. The Aminophylline suppliers may include Aminophylline API manufacturers, exporters, distributors and traders.
click here to find a list of Aminophylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aminophylline DMF (Drug Master File) is a document detailing the whole manufacturing process of Aminophylline active pharmaceutical ingredient (API) in detail. Different forms of Aminophylline DMFs exist exist since differing nations have different regulations, such as Aminophylline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aminophylline DMF submitted to regulatory agencies in the US is known as a USDMF. Aminophylline USDMF includes data on Aminophylline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aminophylline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aminophylline 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 Aminophylline Drug Master File in Japan (Aminophylline JDMF) empowers Aminophylline 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 Aminophylline JDMF during the approval evaluation for pharmaceutical products. At the time of Aminophylline 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 Aminophylline suppliers with JDMF on PharmaCompass.
A Aminophylline CEP of the European Pharmacopoeia monograph is often referred to as a Aminophylline Certificate of Suitability (COS). The purpose of a Aminophylline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aminophylline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aminophylline to their clients by showing that a Aminophylline CEP has been issued for it. The manufacturer submits a Aminophylline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aminophylline CEP holder for the record. Additionally, the data presented in the Aminophylline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aminophylline DMF.
A Aminophylline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aminophylline 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 Aminophylline suppliers with CEP (COS) 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 Aminophylline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aminophylline 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 Aminophylline 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 Aminophylline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aminophylline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aminophylline suppliers with NDC on PharmaCompass.
Aminophylline 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 Aminophylline 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 Aminophylline GMP manufacturer or Aminophylline GMP API supplier for your needs.
A Aminophylline CoA (Certificate of Analysis) is a formal document that attests to Aminophylline's compliance with Aminophylline specifications and serves as a tool for batch-level quality control.
Aminophylline CoA mostly includes findings from lab analyses of a specific batch. For each Aminophylline 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.
Aminophylline may be tested according to a variety of international standards, such as European Pharmacopoeia (Aminophylline EP), Aminophylline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aminophylline USP).