Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
01 1Seqens
02 1Chromo Laboratories
03 1Cipla
04 1Merck Group
05 1Micro Labs Limited
06 1SEQUENT SCIENTIFIC LTD
07 1Shanghai Desano Bio-Pharmaceutical
08 1Solara Active Pharma Sciences
09 1Zhejiang Hisun Pharmaceutical
10 1Blank
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-05
Pay. Date : 2015-09-28
DMF Number : 13999
Submission : 1999-02-24
Status :
Type : II
A Praziquantel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Praziquantel, including repackagers and relabelers. The FDA regulates Praziquantel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Praziquantel 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 Praziquantel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Praziquantel supplier is an individual or a company that provides Praziquantel active pharmaceutical ingredient (API) or Praziquantel finished formulations upon request. The Praziquantel suppliers may include Praziquantel API manufacturers, exporters, distributors and traders.
click here to find a list of Praziquantel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Praziquantel DMF (Drug Master File) is a document detailing the whole manufacturing process of Praziquantel active pharmaceutical ingredient (API) in detail. Different forms of Praziquantel DMFs exist exist since differing nations have different regulations, such as Praziquantel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Praziquantel DMF submitted to regulatory agencies in the US is known as a USDMF. Praziquantel USDMF includes data on Praziquantel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Praziquantel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Praziquantel suppliers with USDMF on PharmaCompass.
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