API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
0
Europe
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
USP
0
JP
0
Other Listed Suppliers
0
0
84
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 033ECH6IFG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 033ECH6IFG, including repackagers and relabelers. The FDA regulates 033ECH6IFG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 033ECH6IFG 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 033ECH6IFG manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 033ECH6IFG supplier is an individual or a company that provides 033ECH6IFG active pharmaceutical ingredient (API) or 033ECH6IFG finished formulations upon request. The 033ECH6IFG suppliers may include 033ECH6IFG API manufacturers, exporters, distributors and traders.
click here to find a list of 033ECH6IFG suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 033ECH6IFG DMF (Drug Master File) is a document detailing the whole manufacturing process of 033ECH6IFG active pharmaceutical ingredient (API) in detail. Different forms of 033ECH6IFG DMFs exist exist since differing nations have different regulations, such as 033ECH6IFG USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 033ECH6IFG DMF submitted to regulatory agencies in the US is known as a USDMF. 033ECH6IFG USDMF includes data on 033ECH6IFG's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 033ECH6IFG USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 033ECH6IFG 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 033ECH6IFG Drug Master File in Japan (033ECH6IFG JDMF) empowers 033ECH6IFG 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 033ECH6IFG JDMF during the approval evaluation for pharmaceutical products. At the time of 033ECH6IFG 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 033ECH6IFG suppliers with JDMF on PharmaCompass.
A 033ECH6IFG CEP of the European Pharmacopoeia monograph is often referred to as a 033ECH6IFG Certificate of Suitability (COS). The purpose of a 033ECH6IFG CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 033ECH6IFG EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 033ECH6IFG to their clients by showing that a 033ECH6IFG CEP has been issued for it. The manufacturer submits a 033ECH6IFG CEP (COS) as part of the market authorization procedure, and it takes on the role of a 033ECH6IFG CEP holder for the record. Additionally, the data presented in the 033ECH6IFG CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 033ECH6IFG DMF.
A 033ECH6IFG CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 033ECH6IFG 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 033ECH6IFG suppliers with CEP (COS) on PharmaCompass.
033ECH6IFG 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 033ECH6IFG 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 033ECH6IFG GMP manufacturer or 033ECH6IFG GMP API supplier for your needs.
A 033ECH6IFG CoA (Certificate of Analysis) is a formal document that attests to 033ECH6IFG's compliance with 033ECH6IFG specifications and serves as a tool for batch-level quality control.
033ECH6IFG CoA mostly includes findings from lab analyses of a specific batch. For each 033ECH6IFG 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.
033ECH6IFG may be tested according to a variety of international standards, such as European Pharmacopoeia (033ECH6IFG EP), 033ECH6IFG JP (Japanese Pharmacopeia) and the US Pharmacopoeia (033ECH6IFG USP).