01 1C-Squared Pharma
02 1UQUIFA
01 2CYCLOPENTOLATE HYDROCHLORIDE
01 1Ireland
02 1Spain
01 2Active
01 2Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-21
Pay. Date : 2021-12-08
DMF Number : 36342
Submission : 2021-10-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-31
Pay. Date : 2013-07-26
DMF Number : 7272
Submission : 1987-12-31
Status : Active
Type : II
A Cyclopentolate Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyclopentolate Hydrochloride, including repackagers and relabelers. The FDA regulates Cyclopentolate Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cyclopentolate Hydrochloride supplier is an individual or a company that provides Cyclopentolate Hydrochloride active pharmaceutical ingredient (API) or Cyclopentolate Hydrochloride finished formulations upon request. The Cyclopentolate Hydrochloride suppliers may include Cyclopentolate Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cyclopentolate Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cyclopentolate Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cyclopentolate Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cyclopentolate Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cyclopentolate Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cyclopentolate Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cyclopentolate Hydrochloride USDMF includes data on Cyclopentolate Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cyclopentolate Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cyclopentolate Hydrochloride suppliers with USDMF on PharmaCompass.
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