01 1ACIC Pharmaceuticals & Equipment
02 1GLAND PHARMA LIMITED
03 1Recordati
04 1SIGMA TAU
01 1B-MERCAPTOCTHYLAMINE HYDROCHLORIDE (CYSTEAMINE)
02 3CYSTEAMINE HYDROCHLORIDE
01 1India
02 1Italy
03 2U.S.A
01 3Active
02 1Inactive
01 1Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36907
Submission : 2022-06-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-23
Pay. Date : 2023-02-09
DMF Number : 37415
Submission : 2022-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32911
Submission : 2019-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2597
Submission : 1976-01-16
Status : Inactive
Type : II
A Cysteamine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cysteamine Hydrochloride, including repackagers and relabelers. The FDA regulates Cysteamine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cysteamine 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 Cysteamine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cysteamine Hydrochloride supplier is an individual or a company that provides Cysteamine Hydrochloride active pharmaceutical ingredient (API) or Cysteamine Hydrochloride finished formulations upon request. The Cysteamine Hydrochloride suppliers may include Cysteamine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cysteamine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cysteamine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cysteamine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cysteamine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cysteamine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cysteamine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cysteamine Hydrochloride USDMF includes data on Cysteamine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cysteamine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cysteamine Hydrochloride suppliers with USDMF on PharmaCompass.
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