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API SUPPLIERS
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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USDMF
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7658
Submission : 1988-09-06
Status :
Type : II
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;30...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 16682
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 17608
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - INJECTABLE;INJECTION - 5MEQ/ML
USFDA APPLICATION NUMBER - 18947
DOSAGE - SOLUTION;IRRIGATION - 20MG/100ML;30M...DOSAGE - SOLUTION;IRRIGATION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19416
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19685
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19685
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19685
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19685
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20163
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20163
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20163
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20171
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20171
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20171
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20183
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20183
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20183
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20183
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PharmaCompass offers a list of Sodium Lactate 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 Sodium Lactate manufacturer or Sodium Lactate supplier for your needs.
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A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4, including repackagers and relabelers. The FDA regulates DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 supplier is an individual or a company that provides DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 active pharmaceutical ingredient (API) or DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 finished formulations upon request. The DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 suppliers may include DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 API manufacturers, exporters, distributors and traders.
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A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 DMF (Drug Master File) is a document detailing the whole manufacturing process of DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 active pharmaceutical ingredient (API) in detail. Different forms of DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 DMFs exist exist since differing nations have different regulations, such as DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 DMF submitted to regulatory agencies in the US is known as a USDMF. DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 USDMF includes data on DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 Drug Master File in Japan (DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 JDMF) empowers DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 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 DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 JDMF during the approval evaluation for pharmaceutical products. At the time of DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP of the European Pharmacopoeia monograph is often referred to as a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 Certificate of Suitability (COS). The purpose of a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 to their clients by showing that a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP has been issued for it. The manufacturer submits a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP (COS) as part of the market authorization procedure, and it takes on the role of a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP holder for the record. Additionally, the data presented in the DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 DMF.
A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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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 DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 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 DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 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 DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 NDC to their finished compounded human drug products, they may choose to do so.
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DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 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 DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 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 DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 GMP manufacturer or DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 GMP API supplier for your needs.
A DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CoA (Certificate of Analysis) is a formal document that attests to DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4's compliance with DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 specifications and serves as a tool for batch-level quality control.
DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 CoA mostly includes findings from lab analyses of a specific batch. For each DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 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.
DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 may be tested according to a variety of international standards, such as European Pharmacopoeia (DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 EP), DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DEXTROSE 5%; LACTATED RINGER'S IN PLASTIC CONTAINER-4 USP).
