X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
77
PharmaCompass offers a list of Imipenem 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 Imipenem manufacturer or Imipenem supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Imipenem manufacturer or Imipenem supplier.
PharmaCompass also assists you with knowing the Imipenem API Price utilized in the formulation of products. Imipenem API Price is not always fixed or binding as the Imipenem Price is obtained through a variety of data sources. The Imipenem Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Imipenem Anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imipenem Anhydrous, including repackagers and relabelers. The FDA regulates Imipenem Anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imipenem Anhydrous 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 Imipenem Anhydrous manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Imipenem Anhydrous supplier is an individual or a company that provides Imipenem Anhydrous active pharmaceutical ingredient (API) or Imipenem Anhydrous finished formulations upon request. The Imipenem Anhydrous suppliers may include Imipenem Anhydrous API manufacturers, exporters, distributors and traders.
click here to find a list of Imipenem Anhydrous suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Imipenem Anhydrous DMF (Drug Master File) is a document detailing the whole manufacturing process of Imipenem Anhydrous active pharmaceutical ingredient (API) in detail. Different forms of Imipenem Anhydrous DMFs exist exist since differing nations have different regulations, such as Imipenem Anhydrous USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imipenem Anhydrous DMF submitted to regulatory agencies in the US is known as a USDMF. Imipenem Anhydrous USDMF includes data on Imipenem Anhydrous's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imipenem Anhydrous USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Imipenem Anhydrous 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 Imipenem Anhydrous Drug Master File in Japan (Imipenem Anhydrous JDMF) empowers Imipenem Anhydrous 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 Imipenem Anhydrous JDMF during the approval evaluation for pharmaceutical products. At the time of Imipenem Anhydrous 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 Imipenem Anhydrous suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Imipenem Anhydrous Drug Master File in Korea (Imipenem Anhydrous KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Imipenem Anhydrous. The MFDS reviews the Imipenem Anhydrous KDMF as part of the drug registration process and uses the information provided in the Imipenem Anhydrous KDMF to evaluate the safety and efficacy of the drug.
After submitting a Imipenem Anhydrous KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Imipenem Anhydrous API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Imipenem Anhydrous suppliers with KDMF on PharmaCompass.
A Imipenem Anhydrous CEP of the European Pharmacopoeia monograph is often referred to as a Imipenem Anhydrous Certificate of Suitability (COS). The purpose of a Imipenem Anhydrous CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Imipenem Anhydrous EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Imipenem Anhydrous to their clients by showing that a Imipenem Anhydrous CEP has been issued for it. The manufacturer submits a Imipenem Anhydrous CEP (COS) as part of the market authorization procedure, and it takes on the role of a Imipenem Anhydrous CEP holder for the record. Additionally, the data presented in the Imipenem Anhydrous CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Imipenem Anhydrous DMF.
A Imipenem Anhydrous CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Imipenem Anhydrous 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 Imipenem Anhydrous suppliers with CEP (COS) on PharmaCompass.
A Imipenem Anhydrous written confirmation (Imipenem Anhydrous WC) is an official document issued by a regulatory agency to a Imipenem Anhydrous manufacturer, verifying that the manufacturing facility of a Imipenem Anhydrous active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Imipenem Anhydrous APIs or Imipenem Anhydrous finished pharmaceutical products to another nation, regulatory agencies frequently require a Imipenem Anhydrous WC (written confirmation) as part of the regulatory process.
click here to find a list of Imipenem Anhydrous suppliers with Written Confirmation (WC) 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 Imipenem Anhydrous as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Imipenem Anhydrous 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 Imipenem Anhydrous 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 Imipenem Anhydrous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Imipenem Anhydrous NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Imipenem Anhydrous suppliers with NDC on PharmaCompass.
Imipenem Anhydrous 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 Imipenem Anhydrous 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 Imipenem Anhydrous GMP manufacturer or Imipenem Anhydrous GMP API supplier for your needs.
A Imipenem Anhydrous CoA (Certificate of Analysis) is a formal document that attests to Imipenem Anhydrous's compliance with Imipenem Anhydrous specifications and serves as a tool for batch-level quality control.
Imipenem Anhydrous CoA mostly includes findings from lab analyses of a specific batch. For each Imipenem Anhydrous 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.
Imipenem Anhydrous may be tested according to a variety of international standards, such as European Pharmacopoeia (Imipenem Anhydrous EP), Imipenem Anhydrous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Imipenem Anhydrous USP).
Market Place
