X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
EU WC
0
Listed Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
20
PharmaCompass offers a list of Orgotein 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 Orgotein manufacturer or Orgotein supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Orgotein manufacturer or Orgotein supplier.
PharmaCompass also assists you with knowing the Orgotein API Price utilized in the formulation of products. Orgotein API Price is not always fixed or binding as the Orgotein Price is obtained through a variety of data sources. The Orgotein Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Orgotein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orgotein, including repackagers and relabelers. The FDA regulates Orgotein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orgotein API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Orgotein supplier is an individual or a company that provides Orgotein active pharmaceutical ingredient (API) or Orgotein finished formulations upon request. The Orgotein suppliers may include Orgotein API manufacturers, exporters, distributors and traders.
click here to find a list of Orgotein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Orgotein DMF (Drug Master File) is a document detailing the whole manufacturing process of Orgotein active pharmaceutical ingredient (API) in detail. Different forms of Orgotein DMFs exist exist since differing nations have different regulations, such as Orgotein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Orgotein DMF submitted to regulatory agencies in the US is known as a USDMF. Orgotein USDMF includes data on Orgotein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orgotein USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Orgotein suppliers with USDMF on PharmaCompass.
A Orgotein CEP of the European Pharmacopoeia monograph is often referred to as a Orgotein Certificate of Suitability (COS). The purpose of a Orgotein CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orgotein EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orgotein to their clients by showing that a Orgotein CEP has been issued for it. The manufacturer submits a Orgotein CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orgotein CEP holder for the record. Additionally, the data presented in the Orgotein CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orgotein DMF.
A Orgotein CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orgotein 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 Orgotein suppliers with CEP (COS) on PharmaCompass.
Orgotein 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 Orgotein 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 Orgotein GMP manufacturer or Orgotein GMP API supplier for your needs.
A Orgotein CoA (Certificate of Analysis) is a formal document that attests to Orgotein's compliance with Orgotein specifications and serves as a tool for batch-level quality control.
Orgotein CoA mostly includes findings from lab analyses of a specific batch. For each Orgotein 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.
Orgotein may be tested according to a variety of international standards, such as European Pharmacopoeia (Orgotein EP), Orgotein JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orgotein USP).
Market Place
