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USDMF
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DOSAGE - POWDER;INTRAVENOUS - EQ 250MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50587
DOSAGE - POWDER;INTRAVENOUS - EQ 500MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL;500MG/VIAL
USFDA APPLICATION NUMBER - 50587
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Imipenem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imipenem, including repackagers and relabelers. The FDA regulates Imipenem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imipenem 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Imipenem supplier is an individual or a company that provides Imipenem active pharmaceutical ingredient (API) or Imipenem finished formulations upon request. The Imipenem suppliers may include Imipenem API manufacturers, exporters, distributors and traders.
click here to find a list of Imipenem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Imipenem DMF (Drug Master File) is a document detailing the whole manufacturing process of Imipenem active pharmaceutical ingredient (API) in detail. Different forms of Imipenem DMFs exist exist since differing nations have different regulations, such as Imipenem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imipenem DMF submitted to regulatory agencies in the US is known as a USDMF. Imipenem USDMF includes data on Imipenem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imipenem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Imipenem 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 Drug Master File in Japan (Imipenem JDMF) empowers Imipenem 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Imipenem 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 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 Drug Master File in Korea (Imipenem KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Imipenem. The MFDS reviews the Imipenem KDMF as part of the drug registration process and uses the information provided in the Imipenem KDMF to evaluate the safety and efficacy of the drug.
After submitting a Imipenem 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Imipenem suppliers with KDMF on PharmaCompass.
A Imipenem CEP of the European Pharmacopoeia monograph is often referred to as a Imipenem Certificate of Suitability (COS). The purpose of a Imipenem CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Imipenem EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Imipenem to their clients by showing that a Imipenem CEP has been issued for it. The manufacturer submits a Imipenem CEP (COS) as part of the market authorization procedure, and it takes on the role of a Imipenem CEP holder for the record. Additionally, the data presented in the Imipenem CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Imipenem DMF.
A Imipenem CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Imipenem 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 suppliers with CEP (COS) on PharmaCompass.
A Imipenem written confirmation (Imipenem WC) is an official document issued by a regulatory agency to a Imipenem manufacturer, verifying that the manufacturing facility of a Imipenem active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Imipenem APIs or Imipenem finished pharmaceutical products to another nation, regulatory agencies frequently require a Imipenem WC (written confirmation) as part of the regulatory process.
click here to find a list of Imipenem 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Imipenem 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Imipenem NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Imipenem suppliers with NDC on PharmaCompass.
Imipenem 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 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 GMP manufacturer or Imipenem GMP API supplier for your needs.
A Imipenem CoA (Certificate of Analysis) is a formal document that attests to Imipenem's compliance with Imipenem specifications and serves as a tool for batch-level quality control.
Imipenem CoA mostly includes findings from lab analyses of a specific batch. For each Imipenem 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Imipenem EP), Imipenem JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Imipenem USP).
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