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DOSAGE - POWDER;INTRAVENOUS - 1GM/VIAL;1GM/VI...DOSAGE - POWDER;INTRAVENOUS - 1GM/VIAL;1GM/VIAL
USFDA APPLICATION NUMBER - 209776
DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL
USFDA APPLICATION NUMBER - 50706
DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL
USFDA APPLICATION NUMBER - 50706
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ABOUT THIS PAGE
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PharmaCompass offers a list of Meropenem 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 Meropenem manufacturer or Meropenem supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Meropenem manufacturer or Meropenem supplier.
PharmaCompass also assists you with knowing the Meropenem API Price utilized in the formulation of products. Meropenem API Price is not always fixed or binding as the Meropenem Price is obtained through a variety of data sources. The Meropenem Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Meropenem Trihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meropenem Trihydrate, including repackagers and relabelers. The FDA regulates Meropenem Trihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meropenem Trihydrate 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 Meropenem Trihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Meropenem Trihydrate supplier is an individual or a company that provides Meropenem Trihydrate active pharmaceutical ingredient (API) or Meropenem Trihydrate finished formulations upon request. The Meropenem Trihydrate suppliers may include Meropenem Trihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Meropenem Trihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Meropenem Trihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Meropenem Trihydrate active pharmaceutical ingredient (API) in detail. Different forms of Meropenem Trihydrate DMFs exist exist since differing nations have different regulations, such as Meropenem Trihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Meropenem Trihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Meropenem Trihydrate USDMF includes data on Meropenem Trihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Meropenem Trihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Meropenem Trihydrate 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 Meropenem Trihydrate Drug Master File in Japan (Meropenem Trihydrate JDMF) empowers Meropenem Trihydrate 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 Meropenem Trihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Meropenem Trihydrate 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 Meropenem Trihydrate 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 Meropenem Trihydrate Drug Master File in Korea (Meropenem Trihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Meropenem Trihydrate. The MFDS reviews the Meropenem Trihydrate KDMF as part of the drug registration process and uses the information provided in the Meropenem Trihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Meropenem Trihydrate 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 Meropenem Trihydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Meropenem Trihydrate suppliers with KDMF on PharmaCompass.
A Meropenem Trihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Meropenem Trihydrate Certificate of Suitability (COS). The purpose of a Meropenem Trihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Meropenem Trihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Meropenem Trihydrate to their clients by showing that a Meropenem Trihydrate CEP has been issued for it. The manufacturer submits a Meropenem Trihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Meropenem Trihydrate CEP holder for the record. Additionally, the data presented in the Meropenem Trihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Meropenem Trihydrate DMF.
A Meropenem Trihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Meropenem Trihydrate 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 Meropenem Trihydrate suppliers with CEP (COS) on PharmaCompass.
A Meropenem Trihydrate written confirmation (Meropenem Trihydrate WC) is an official document issued by a regulatory agency to a Meropenem Trihydrate manufacturer, verifying that the manufacturing facility of a Meropenem Trihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Meropenem Trihydrate APIs or Meropenem Trihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Meropenem Trihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Meropenem Trihydrate 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 Meropenem Trihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Meropenem Trihydrate 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 Meropenem Trihydrate 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 Meropenem Trihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Meropenem Trihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Meropenem Trihydrate suppliers with NDC on PharmaCompass.
Meropenem Trihydrate 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 Meropenem Trihydrate 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 Meropenem Trihydrate GMP manufacturer or Meropenem Trihydrate GMP API supplier for your needs.
A Meropenem Trihydrate CoA (Certificate of Analysis) is a formal document that attests to Meropenem Trihydrate's compliance with Meropenem Trihydrate specifications and serves as a tool for batch-level quality control.
Meropenem Trihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Meropenem Trihydrate 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.
Meropenem Trihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Meropenem Trihydrate EP), Meropenem Trihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Meropenem Trihydrate USP).
