Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories
02 1Chunghwa Chemical Synthesis & Biotech
03 1ALP Pharm
04 1Cipla
05 1MSN Laboratories
06 1Wisdom Pharmaceutical
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.
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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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difelikefalin, including repackagers and relabelers. The FDA regulates Difelikefalin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difelikefalin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Difelikefalin supplier is an individual or a company that provides Difelikefalin active pharmaceutical ingredient (API) or Difelikefalin finished formulations upon request. The Difelikefalin suppliers may include Difelikefalin API manufacturers, exporters, distributors and traders.
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A Difelikefalin DMF (Drug Master File) is a document detailing the whole manufacturing process of Difelikefalin active pharmaceutical ingredient (API) in detail. Different forms of Difelikefalin DMFs exist exist since differing nations have different regulations, such as Difelikefalin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Difelikefalin DMF submitted to regulatory agencies in the US is known as a USDMF. Difelikefalin USDMF includes data on Difelikefalin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Difelikefalin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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