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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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.
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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.
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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.
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