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
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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Aspen API. More than just an API™
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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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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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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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 - 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
Digital Content
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Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
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 Somatuline Autogel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Somatuline Autogel, including repackagers and relabelers. The FDA regulates Somatuline Autogel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Somatuline Autogel 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 Somatuline Autogel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Somatuline Autogel supplier is an individual or a company that provides Somatuline Autogel active pharmaceutical ingredient (API) or Somatuline Autogel finished formulations upon request. The Somatuline Autogel suppliers may include Somatuline Autogel API manufacturers, exporters, distributors and traders.
click here to find a list of Somatuline Autogel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Somatuline Autogel DMF (Drug Master File) is a document detailing the whole manufacturing process of Somatuline Autogel active pharmaceutical ingredient (API) in detail. Different forms of Somatuline Autogel DMFs exist exist since differing nations have different regulations, such as Somatuline Autogel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Somatuline Autogel DMF submitted to regulatory agencies in the US is known as a USDMF. Somatuline Autogel USDMF includes data on Somatuline Autogel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Somatuline Autogel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Somatuline Autogel 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 Somatuline Autogel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Somatuline Autogel 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 Somatuline Autogel 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 Somatuline Autogel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Somatuline Autogel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Somatuline Autogel suppliers with NDC on PharmaCompass.
Somatuline Autogel 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 Somatuline Autogel 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 Somatuline Autogel GMP manufacturer or Somatuline Autogel GMP API supplier for your needs.
A Somatuline Autogel CoA (Certificate of Analysis) is a formal document that attests to Somatuline Autogel's compliance with Somatuline Autogel specifications and serves as a tool for batch-level quality control.
Somatuline Autogel CoA mostly includes findings from lab analyses of a specific batch. For each Somatuline Autogel 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.
Somatuline Autogel may be tested according to a variety of international standards, such as European Pharmacopoeia (Somatuline Autogel EP), Somatuline Autogel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Somatuline Autogel USP).
