Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Aspen API
03 13M Drug Delivery Systems
04 1Bayer AG
05 1Catalent Pharma Solutions
06 1Fareva
07 1Gedeon Richter
08 1Lupin Ltd
09 1Merck & Co
10 1Perlen Packaging
11 1Productos Quimicos Naturales
01 1(18F) FES,16 ALPHA-[18F]-FLUORO-17BETAESTRADIOL
02 117 ALPHA-ESTRADIOL
03 1ALPHA-ESTRADIOL
04 2ESTRADIOL
05 1ESTRADIOL HEMIHYDRATE
06 2ESTRADIOL HEMIHYDRATE USP
07 1ESTRADIOL TRANSDERMAL DRUG DELIVERY SYSTEM
08 1ESTRADIOL USP
09 1ESTRADIOL VAGINAL SOFT GELATIN CAPSULES
01 1Germany
02 1Hungary
03 2India
04 1Luxembourg
05 1Mexico
06 1Netherlands
07 1Switzerland
08 3U.S.A
01 7Active
02 4Inactive
01 6Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-20
Pay. Date : 2020-03-23
DMF Number : 34147
Submission : 2019-09-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-11-20
DMF Number : 3829
Submission : 1980-05-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9841
Submission : 1992-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-28
Pay. Date : 2013-01-08
DMF Number : 4684
Submission : 1982-10-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22843
Submission : 2009-06-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-04-24
DMF Number : 22972
Submission : 2009-07-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-24
Pay. Date : 2016-04-26
DMF Number : 4066
Submission : 1981-01-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-05
Pay. Date : 2013-02-26
DMF Number : 25816
Submission : 2012-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1388
Submission : 1969-07-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23856
Submission : 2010-05-27
Status : Inactive
Type : II
A Estrogens, esterified manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estrogens, esterified, including repackagers and relabelers. The FDA regulates Estrogens, esterified manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estrogens, esterified 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 Estrogens, esterified manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estrogens, esterified supplier is an individual or a company that provides Estrogens, esterified active pharmaceutical ingredient (API) or Estrogens, esterified finished formulations upon request. The Estrogens, esterified suppliers may include Estrogens, esterified API manufacturers, exporters, distributors and traders.
click here to find a list of Estrogens, esterified suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estrogens, esterified DMF (Drug Master File) is a document detailing the whole manufacturing process of Estrogens, esterified active pharmaceutical ingredient (API) in detail. Different forms of Estrogens, esterified DMFs exist exist since differing nations have different regulations, such as Estrogens, esterified USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estrogens, esterified DMF submitted to regulatory agencies in the US is known as a USDMF. Estrogens, esterified USDMF includes data on Estrogens, esterified's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estrogens, esterified USDMF is kept confidential to protect the manufacturer’s intellectual property.
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