Synopsis
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CEP/COS
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KDMF
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VMF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4846
Submission : 1983-03-11
Status :
Type : II
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen, solo star
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal OptiSet
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Comb 25
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Comb 25 OptiSet
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Infusat
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Rapid
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Rapid
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Rapid OptiSet
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : ADMELOG SOLOSTAR
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 3ML PREFILLED PEN
Approval Date :
Application Number : 2469871
Regulatory Info : Schedule D
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : ADMELOG
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 3ML CARTRIDGE
Approval Date :
Application Number : 2469898
Regulatory Info : Schedule D
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : ADMELOG
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 10ML VIAL
Approval Date :
Application Number : 2469901
Regulatory Info : Schedule D
Registration Country : Canada
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EUROAPI
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PharmaCompass offers a list of Insulin Lispro 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 Insulin Lispro manufacturer or Insulin Lispro supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Insulin Lispro manufacturer or Insulin Lispro supplier.
PharmaCompass also assists you with knowing the Insulin Lispro API Price utilized in the formulation of products. Insulin Lispro API Price is not always fixed or binding as the Insulin Lispro Price is obtained through a variety of data sources. The Insulin Lispro Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Insulin Lispro manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Insulin Lispro, including repackagers and relabelers. The FDA regulates Insulin Lispro manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Insulin Lispro 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 Insulin Lispro manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Insulin Lispro supplier is an individual or a company that provides Insulin Lispro active pharmaceutical ingredient (API) or Insulin Lispro finished formulations upon request. The Insulin Lispro suppliers may include Insulin Lispro API manufacturers, exporters, distributors and traders.
click here to find a list of Insulin Lispro suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Insulin Lispro DMF (Drug Master File) is a document detailing the whole manufacturing process of Insulin Lispro active pharmaceutical ingredient (API) in detail. Different forms of Insulin Lispro DMFs exist exist since differing nations have different regulations, such as Insulin Lispro USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Insulin Lispro DMF submitted to regulatory agencies in the US is known as a USDMF. Insulin Lispro USDMF includes data on Insulin Lispro's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Insulin Lispro USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Insulin Lispro 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 Insulin Lispro Drug Master File in Japan (Insulin Lispro JDMF) empowers Insulin Lispro 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 Insulin Lispro JDMF during the approval evaluation for pharmaceutical products. At the time of Insulin Lispro 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 Insulin Lispro suppliers with JDMF on PharmaCompass.
Insulin Lispro 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 Insulin Lispro 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 Insulin Lispro GMP manufacturer or Insulin Lispro GMP API supplier for your needs.
A Insulin Lispro CoA (Certificate of Analysis) is a formal document that attests to Insulin Lispro's compliance with Insulin Lispro specifications and serves as a tool for batch-level quality control.
Insulin Lispro CoA mostly includes findings from lab analyses of a specific batch. For each Insulin Lispro 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.
Insulin Lispro may be tested according to a variety of international standards, such as European Pharmacopoeia (Insulin Lispro EP), Insulin Lispro JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Insulin Lispro USP).
