Synopsis
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EU WC
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KDMF
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VMF
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EDQM
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USP
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JP
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FDF Dossiers
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FDA Orange Book
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Europe
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API SUPPLIERS
Fujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.
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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
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USDMF
Fujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42393
Submission : 2025-09-16
Status :
Type : II
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ABOUT THIS PAGE
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PharmaCompass offers a list of Orforglipron Calcium Hydrate 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 Orforglipron Calcium Hydrate manufacturer or Orforglipron Calcium Hydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Orforglipron Calcium Hydrate manufacturer or Orforglipron Calcium Hydrate supplier.
PharmaCompass also assists you with knowing the Orforglipron Calcium Hydrate API Price utilized in the formulation of products. Orforglipron Calcium Hydrate API Price is not always fixed or binding as the Orforglipron Calcium Hydrate Price is obtained through a variety of data sources. The Orforglipron Calcium Hydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Orforglipron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orforglipron, including repackagers and relabelers. The FDA regulates Orforglipron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orforglipron 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 Orforglipron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Orforglipron supplier is an individual or a company that provides Orforglipron active pharmaceutical ingredient (API) or Orforglipron finished formulations upon request. The Orforglipron suppliers may include Orforglipron API manufacturers, exporters, distributors and traders.
click here to find a list of Orforglipron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Orforglipron DMF (Drug Master File) is a document detailing the whole manufacturing process of Orforglipron active pharmaceutical ingredient (API) in detail. Different forms of Orforglipron DMFs exist exist since differing nations have different regulations, such as Orforglipron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Orforglipron DMF submitted to regulatory agencies in the US is known as a USDMF. Orforglipron USDMF includes data on Orforglipron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orforglipron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Orforglipron 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 Orforglipron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Orforglipron 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 Orforglipron 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 Orforglipron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Orforglipron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Orforglipron suppliers with NDC on PharmaCompass.
Orforglipron 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 Orforglipron 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 Orforglipron GMP manufacturer or Orforglipron GMP API supplier for your needs.
A Orforglipron CoA (Certificate of Analysis) is a formal document that attests to Orforglipron's compliance with Orforglipron specifications and serves as a tool for batch-level quality control.
Orforglipron CoA mostly includes findings from lab analyses of a specific batch. For each Orforglipron 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.
Orforglipron may be tested according to a variety of international standards, such as European Pharmacopoeia (Orforglipron EP), Orforglipron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orforglipron USP).
