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Neuland Laboratories- A dedicated 100% API provider.
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Vtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC 
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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USDMF
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41503
Submission : 2025-03-26
Status :
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38511
Submission : 2023-06-19
Status :
Type : II
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PharmaCompass offers a list of Difelikefalin 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 Difelikefalin Acetate manufacturer or Difelikefalin Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Difelikefalin Acetate manufacturer or Difelikefalin Acetate supplier.
PharmaCompass also assists you with knowing the Difelikefalin Acetate API Price utilized in the formulation of products. Difelikefalin Acetate API Price is not always fixed or binding as the Difelikefalin Acetate Price is obtained through a variety of data sources. The Difelikefalin Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Difelikefalin Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difelikefalin Acetate, including repackagers and relabelers. The FDA regulates Difelikefalin Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difelikefalin Acetate 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 Difelikefalin Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Difelikefalin Acetate supplier is an individual or a company that provides Difelikefalin Acetate active pharmaceutical ingredient (API) or Difelikefalin Acetate finished formulations upon request. The Difelikefalin Acetate suppliers may include Difelikefalin Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Difelikefalin Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Difelikefalin Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Difelikefalin Acetate active pharmaceutical ingredient (API) in detail. Different forms of Difelikefalin Acetate DMFs exist exist since differing nations have different regulations, such as Difelikefalin Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Difelikefalin Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Difelikefalin Acetate USDMF includes data on Difelikefalin Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Difelikefalin Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Difelikefalin Acetate 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 Difelikefalin Acetate Drug Master File in Japan (Difelikefalin Acetate JDMF) empowers Difelikefalin Acetate 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 Difelikefalin Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Difelikefalin Acetate 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 Difelikefalin Acetate suppliers with JDMF 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 Difelikefalin Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Difelikefalin Acetate 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 Difelikefalin Acetate 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 Difelikefalin Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Difelikefalin Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Difelikefalin Acetate suppliers with NDC on PharmaCompass.
Difelikefalin Acetate 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 Difelikefalin Acetate 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 Difelikefalin Acetate GMP manufacturer or Difelikefalin Acetate GMP API supplier for your needs.
A Difelikefalin Acetate CoA (Certificate of Analysis) is a formal document that attests to Difelikefalin Acetate's compliance with Difelikefalin Acetate specifications and serves as a tool for batch-level quality control.
Difelikefalin Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Difelikefalin Acetate 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.
Difelikefalin Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Difelikefalin Acetate EP), Difelikefalin Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Difelikefalin Acetate USP).
