Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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 : 2019-11-19
Pay. Date : 2019-09-19
DMF Number : 34145
Submission : 2019-09-27
Status :
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38662
Submission : 2023-10-23
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-27
Pay. Date : 2012-11-09
DMF Number : 17777
Submission : 2004-10-21
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - EQ 0.05MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.05MG BASE/ML
USFDA APPLICATION NUMBER - 19667
DOSAGE - INJECTABLE;INJECTION - EQ 0.1MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.1MG BASE/ML
USFDA APPLICATION NUMBER - 19667
DOSAGE - INJECTABLE;INJECTION - EQ 0.2MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19667
DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE/ML
USFDA APPLICATION NUMBER - 19667
DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19667
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)
USFDA APPLICATION NUMBER - 213224
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Chewable & Orodispersible Aids
Parenteral
Direct Compression
Taste Masking
Disintegrants & Superdisintegrants
API Stability Enhancers
Granulation
Co-Processed Excipients
Topical
Thickeners and Stabilizers
Solubilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
54
PharmaCompass offers a list of Octreotide Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Octreotide Acetate manufacturer or Octreotide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Octreotide Acetate manufacturer or Octreotide Acetate supplier.
A Octreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Octreotide, including repackagers and relabelers. The FDA regulates Octreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Octreotide 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 Octreotide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Octreotide supplier is an individual or a company that provides Octreotide active pharmaceutical ingredient (API) or Octreotide finished formulations upon request. The Octreotide suppliers may include Octreotide API manufacturers, exporters, distributors and traders.
click here to find a list of Octreotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Octreotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Octreotide active pharmaceutical ingredient (API) in detail. Different forms of Octreotide DMFs exist exist since differing nations have different regulations, such as Octreotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Octreotide DMF submitted to regulatory agencies in the US is known as a USDMF. Octreotide USDMF includes data on Octreotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Octreotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Octreotide 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 Octreotide Drug Master File in Japan (Octreotide JDMF) empowers Octreotide 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 Octreotide JDMF during the approval evaluation for pharmaceutical products. At the time of Octreotide 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 Octreotide 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 Octreotide Drug Master File in Korea (Octreotide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Octreotide. The MFDS reviews the Octreotide KDMF as part of the drug registration process and uses the information provided in the Octreotide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Octreotide 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 Octreotide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Octreotide suppliers with KDMF on PharmaCompass.
A Octreotide CEP of the European Pharmacopoeia monograph is often referred to as a Octreotide Certificate of Suitability (COS). The purpose of a Octreotide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Octreotide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Octreotide to their clients by showing that a Octreotide CEP has been issued for it. The manufacturer submits a Octreotide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Octreotide CEP holder for the record. Additionally, the data presented in the Octreotide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Octreotide DMF.
A Octreotide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Octreotide 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 Octreotide suppliers with CEP (COS) on PharmaCompass.
A Octreotide written confirmation (Octreotide WC) is an official document issued by a regulatory agency to a Octreotide manufacturer, verifying that the manufacturing facility of a Octreotide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Octreotide APIs or Octreotide finished pharmaceutical products to another nation, regulatory agencies frequently require a Octreotide WC (written confirmation) as part of the regulatory process.
click here to find a list of Octreotide 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 Octreotide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Octreotide 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 Octreotide 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 Octreotide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Octreotide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Octreotide suppliers with NDC on PharmaCompass.
Octreotide 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 Octreotide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Octreotide GMP manufacturer or Octreotide GMP API supplier for your needs.
A Octreotide CoA (Certificate of Analysis) is a formal document that attests to Octreotide's compliance with Octreotide specifications and serves as a tool for batch-level quality control.
Octreotide CoA mostly includes findings from lab analyses of a specific batch. For each Octreotide 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.
Octreotide may be tested according to a variety of international standards, such as European Pharmacopoeia (Octreotide EP), Octreotide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Octreotide USP).
