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