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Regulatory Info :
Registration Country : India
Brand Name : Doripenem
Dosage Form : Sterile Vial
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Together we can improve the quality of life
Regulatory Info :
Registration Country : India
Brand Name : Doripenem
Dosage Form : Sterile Vial
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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DOSAGE - INJECTABLE;INTRAVENOUS - 250MG/VIAL ...DOSAGE - INJECTABLE;INTRAVENOUS - 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22106
DOSAGE - INJECTABLE;INTRAVENOUS - 500MG/VIAL ...DOSAGE - INJECTABLE;INTRAVENOUS - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22106
Market Place
FDF DOSSIERS
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28 Oct 2024
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25 Mar 2022
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18 Feb 2019
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28 Sep 2016
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Doripenem 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 Doripenem manufacturer or Doripenem supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Doripenem manufacturer or Doripenem supplier.
PharmaCompass also assists you with knowing the Doripenem API Price utilized in the formulation of products. Doripenem API Price is not always fixed or binding as the Doripenem Price is obtained through a variety of data sources. The Doripenem Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Doripenem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Doripenem, including repackagers and relabelers. The FDA regulates Doripenem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Doripenem 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 Doripenem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Doripenem supplier is an individual or a company that provides Doripenem active pharmaceutical ingredient (API) or Doripenem finished formulations upon request. The Doripenem suppliers may include Doripenem API manufacturers, exporters, distributors and traders.
click here to find a list of Doripenem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Doripenem DMF (Drug Master File) is a document detailing the whole manufacturing process of Doripenem active pharmaceutical ingredient (API) in detail. Different forms of Doripenem DMFs exist exist since differing nations have different regulations, such as Doripenem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Doripenem DMF submitted to regulatory agencies in the US is known as a USDMF. Doripenem USDMF includes data on Doripenem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Doripenem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Doripenem suppliers with USDMF 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 Doripenem Drug Master File in Korea (Doripenem KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Doripenem. The MFDS reviews the Doripenem KDMF as part of the drug registration process and uses the information provided in the Doripenem KDMF to evaluate the safety and efficacy of the drug.
After submitting a Doripenem 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 Doripenem API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Doripenem suppliers with KDMF on PharmaCompass.
A Doripenem written confirmation (Doripenem WC) is an official document issued by a regulatory agency to a Doripenem manufacturer, verifying that the manufacturing facility of a Doripenem active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Doripenem APIs or Doripenem finished pharmaceutical products to another nation, regulatory agencies frequently require a Doripenem WC (written confirmation) as part of the regulatory process.
click here to find a list of Doripenem suppliers with Written Confirmation (WC) on PharmaCompass.
Doripenem 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 Doripenem 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 Doripenem GMP manufacturer or Doripenem GMP API supplier for your needs.
A Doripenem CoA (Certificate of Analysis) is a formal document that attests to Doripenem's compliance with Doripenem specifications and serves as a tool for batch-level quality control.
Doripenem CoA mostly includes findings from lab analyses of a specific batch. For each Doripenem 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.
Doripenem may be tested according to a variety of international standards, such as European Pharmacopoeia (Doripenem EP), Doripenem JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Doripenem USP).
Comment (3)
