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