Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-03
Pay. Date : 2019-02-01
DMF Number : 33336
Submission : 2019-02-08
Status :
Type : II
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Drugs in Development
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DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BAS...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
USFDA APPLICATION NUMBER - 215395
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
USFDA APPLICATION NUMBER - 215395
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
USFDA APPLICATION NUMBER - 215395
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BAS...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
USFDA APPLICATION NUMBER - 22074
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
USFDA APPLICATION NUMBER - 22074
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
USFDA APPLICATION NUMBER - 22074
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ABOUT THIS PAGE
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PharmaCompass offers a list of Lanreotide Acetate 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 Lanreotide Acetate manufacturer or Lanreotide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lanreotide Acetate manufacturer or Lanreotide Acetate supplier.
PharmaCompass also assists you with knowing the Lanreotide Acetate API Price utilized in the formulation of products. Lanreotide Acetate API Price is not always fixed or binding as the Lanreotide Acetate Price is obtained through a variety of data sources. The Lanreotide Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lanreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lanreotide, including repackagers and relabelers. The FDA regulates Lanreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lanreotide 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 Lanreotide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lanreotide supplier is an individual or a company that provides Lanreotide active pharmaceutical ingredient (API) or Lanreotide finished formulations upon request. The Lanreotide suppliers may include Lanreotide API manufacturers, exporters, distributors and traders.
click here to find a list of Lanreotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lanreotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Lanreotide active pharmaceutical ingredient (API) in detail. Different forms of Lanreotide DMFs exist exist since differing nations have different regulations, such as Lanreotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lanreotide DMF submitted to regulatory agencies in the US is known as a USDMF. Lanreotide USDMF includes data on Lanreotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lanreotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lanreotide suppliers with USDMF 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 Lanreotide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lanreotide 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 Lanreotide 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 Lanreotide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lanreotide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lanreotide suppliers with NDC on PharmaCompass.
Lanreotide 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 Lanreotide 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 Lanreotide GMP manufacturer or Lanreotide GMP API supplier for your needs.
A Lanreotide CoA (Certificate of Analysis) is a formal document that attests to Lanreotide's compliance with Lanreotide specifications and serves as a tool for batch-level quality control.
Lanreotide CoA mostly includes findings from lab analyses of a specific batch. For each Lanreotide 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.
Lanreotide may be tested according to a variety of international standards, such as European Pharmacopoeia (Lanreotide EP), Lanreotide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lanreotide USP).
