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