01 1Harman Finochem
02 1Suven Life Sciences Limited
01 1GLYCOPYRROLATE TOSYLATE
02 1GLYCOPYRRONIUM TOSYLATE
01 2India
01 2Active
01 2Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-25
Pay. Date : 2019-09-19
DMF Number : 34111
Submission : 2019-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-04
Pay. Date : 2019-08-02
DMF Number : 33667
Submission : 2019-07-30
Status : Active
Type : II
A Glycopyrronium Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycopyrronium Tosylate, including repackagers and relabelers. The FDA regulates Glycopyrronium Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycopyrronium Tosylate 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 Glycopyrronium Tosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycopyrronium Tosylate supplier is an individual or a company that provides Glycopyrronium Tosylate active pharmaceutical ingredient (API) or Glycopyrronium Tosylate finished formulations upon request. The Glycopyrronium Tosylate suppliers may include Glycopyrronium Tosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Glycopyrronium Tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycopyrronium Tosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycopyrronium Tosylate active pharmaceutical ingredient (API) in detail. Different forms of Glycopyrronium Tosylate DMFs exist exist since differing nations have different regulations, such as Glycopyrronium Tosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycopyrronium Tosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Glycopyrronium Tosylate USDMF includes data on Glycopyrronium Tosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycopyrronium Tosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycopyrronium Tosylate suppliers with USDMF on PharmaCompass.
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