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- EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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