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