01 1Lupin Ltd
02 1Symbiotica Specialty Ingredients
03 1Taro Pharmaceutical Industries
04 1Trifarma
01 1HYDROCORTISONE 17-VALERATE, USP
02 1HYDROCORTISONE VALERATE
03 2HYDROCORTISONE VALERATE USP
01 1India
02 1Italy
03 1Malaysia
04 1U.S.A
01 4Active
01 3Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-02
Pay. Date : 2017-01-09
DMF Number : 31143
Submission : 2016-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-07
Pay. Date : 2017-06-05
DMF Number : 31423
Submission : 2017-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13921
Submission : 1998-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-07
Pay. Date : 2019-04-29
DMF Number : 33334
Submission : 2018-12-19
Status : Active
Type : II
A Hydrocortisone Valerate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrocortisone Valerate, including repackagers and relabelers. The FDA regulates Hydrocortisone Valerate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrocortisone Valerate 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 Hydrocortisone Valerate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrocortisone Valerate supplier is an individual or a company that provides Hydrocortisone Valerate active pharmaceutical ingredient (API) or Hydrocortisone Valerate finished formulations upon request. The Hydrocortisone Valerate suppliers may include Hydrocortisone Valerate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrocortisone Valerate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydrocortisone Valerate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydrocortisone Valerate active pharmaceutical ingredient (API) in detail. Different forms of Hydrocortisone Valerate DMFs exist exist since differing nations have different regulations, such as Hydrocortisone Valerate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydrocortisone Valerate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydrocortisone Valerate USDMF includes data on Hydrocortisone Valerate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydrocortisone Valerate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydrocortisone Valerate suppliers with USDMF on PharmaCompass.
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