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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-04
Pay. Date : 2014-07-10
DMF Number : 28356
Submission : 2014-06-16
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28296
Submission : 2014-05-23
Status :
Type : II
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About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with over 26 years of expertise in human and veterinary pharmaceuticals. Operating in 40+ countries, we own two st...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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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- EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Imipenem 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 Imipenem manufacturer or Imipenem supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Imipenem manufacturer or Imipenem supplier.
PharmaCompass also assists you with knowing the Imipenem API Price utilized in the formulation of products. Imipenem API Price is not always fixed or binding as the Imipenem Price is obtained through a variety of data sources. The Imipenem Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A IMIPENEM AND CILASTATIN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of IMIPENEM AND CILASTATIN, including repackagers and relabelers. The FDA regulates IMIPENEM AND CILASTATIN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. IMIPENEM AND 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 AND CILASTATIN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A IMIPENEM AND CILASTATIN supplier is an individual or a company that provides IMIPENEM AND CILASTATIN active pharmaceutical ingredient (API) or IMIPENEM AND CILASTATIN finished formulations upon request. The IMIPENEM AND CILASTATIN suppliers may include IMIPENEM AND CILASTATIN API manufacturers, exporters, distributors and traders.
click here to find a list of IMIPENEM AND CILASTATIN suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A IMIPENEM AND CILASTATIN DMF (Drug Master File) is a document detailing the whole manufacturing process of IMIPENEM AND CILASTATIN active pharmaceutical ingredient (API) in detail. Different forms of IMIPENEM AND CILASTATIN DMFs exist exist since differing nations have different regulations, such as IMIPENEM AND CILASTATIN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A IMIPENEM AND CILASTATIN DMF submitted to regulatory agencies in the US is known as a USDMF. IMIPENEM AND CILASTATIN USDMF includes data on IMIPENEM AND CILASTATIN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The IMIPENEM AND CILASTATIN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of IMIPENEM AND 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 AND CILASTATIN Drug Master File in Japan (IMIPENEM AND CILASTATIN JDMF) empowers IMIPENEM AND 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 AND CILASTATIN JDMF during the approval evaluation for pharmaceutical products. At the time of IMIPENEM AND 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 AND 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 AND CILASTATIN Drug Master File in Korea (IMIPENEM AND CILASTATIN KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of IMIPENEM AND CILASTATIN. The MFDS reviews the IMIPENEM AND CILASTATIN KDMF as part of the drug registration process and uses the information provided in the IMIPENEM AND CILASTATIN KDMF to evaluate the safety and efficacy of the drug.
After submitting a IMIPENEM AND 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 AND CILASTATIN API can apply through the Korea Drug Master File (KDMF).
click here to find a list of IMIPENEM AND CILASTATIN suppliers with KDMF on PharmaCompass.
A IMIPENEM AND CILASTATIN CEP of the European Pharmacopoeia monograph is often referred to as a IMIPENEM AND CILASTATIN Certificate of Suitability (COS). The purpose of a IMIPENEM AND CILASTATIN CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of IMIPENEM AND CILASTATIN EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of IMIPENEM AND CILASTATIN to their clients by showing that a IMIPENEM AND CILASTATIN CEP has been issued for it. The manufacturer submits a IMIPENEM AND CILASTATIN CEP (COS) as part of the market authorization procedure, and it takes on the role of a IMIPENEM AND CILASTATIN CEP holder for the record. Additionally, the data presented in the IMIPENEM AND CILASTATIN CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the IMIPENEM AND CILASTATIN DMF.
A IMIPENEM AND CILASTATIN CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. IMIPENEM AND 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 AND CILASTATIN suppliers with CEP (COS) on PharmaCompass.
A IMIPENEM AND CILASTATIN written confirmation (IMIPENEM AND CILASTATIN WC) is an official document issued by a regulatory agency to a IMIPENEM AND CILASTATIN manufacturer, verifying that the manufacturing facility of a IMIPENEM AND CILASTATIN active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting IMIPENEM AND CILASTATIN APIs or IMIPENEM AND CILASTATIN finished pharmaceutical products to another nation, regulatory agencies frequently require a IMIPENEM AND CILASTATIN WC (written confirmation) as part of the regulatory process.
click here to find a list of IMIPENEM AND 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 AND CILASTATIN as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for IMIPENEM AND 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 AND 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 AND CILASTATIN and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a IMIPENEM AND CILASTATIN NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of IMIPENEM AND CILASTATIN suppliers with NDC on PharmaCompass.
IMIPENEM AND 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 AND 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 AND CILASTATIN GMP manufacturer or IMIPENEM AND CILASTATIN GMP API supplier for your needs.
A IMIPENEM AND CILASTATIN CoA (Certificate of Analysis) is a formal document that attests to IMIPENEM AND CILASTATIN's compliance with IMIPENEM AND CILASTATIN specifications and serves as a tool for batch-level quality control.
IMIPENEM AND CILASTATIN CoA mostly includes findings from lab analyses of a specific batch. For each IMIPENEM AND 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 AND CILASTATIN may be tested according to a variety of international standards, such as European Pharmacopoeia (IMIPENEM AND CILASTATIN EP), IMIPENEM AND CILASTATIN JP (Japanese Pharmacopeia) and the US Pharmacopoeia (IMIPENEM AND CILASTATIN USP).
