TAPI offers customized CDMO Solutions for API development and manufacturing services.
01 1TAPI Technology & API Services
02 1Auro Peptides Limited
03 1Chengdu Shengnuo Biopharm
04 1CordenPharma
05 2Hybio Pharmaceutical
06 2MSN Laboratories
07 2PolyPeptide Group
08 1Sun Pharmaceutical Industries Limited
09 1Blank
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-25
Pay. Date : 2016-02-12
DMF Number : 30274
Submission : 2016-03-10
Status :
Type : II
A Linaclotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linaclotide, including repackagers and relabelers. The FDA regulates Linaclotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linaclotide 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 Linaclotide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Linaclotide supplier is an individual or a company that provides Linaclotide active pharmaceutical ingredient (API) or Linaclotide finished formulations upon request. The Linaclotide suppliers may include Linaclotide API manufacturers, exporters, distributors and traders.
click here to find a list of Linaclotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Linaclotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Linaclotide active pharmaceutical ingredient (API) in detail. Different forms of Linaclotide DMFs exist exist since differing nations have different regulations, such as Linaclotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Linaclotide DMF submitted to regulatory agencies in the US is known as a USDMF. Linaclotide USDMF includes data on Linaclotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Linaclotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Linaclotide suppliers with USDMF on PharmaCompass.
We have 8 companies offering Linaclotide
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