Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Bayer AG
03 1Gedeon Richter
04 2Industriale Chimica
05 1Lupin Ltd
06 2NEWCHEM SPA
07 1Sterling Spa
08 1Sun Pharmaceutical Industries Limited
09 1Blank
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32885
Submission : 2018-08-30
Status :
Type : II
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A (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione, including repackagers and relabelers. The FDA regulates (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione 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 (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione supplier is an individual or a company that provides (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione active pharmaceutical ingredient (API) or (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione finished formulations upon request. The (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione suppliers may include (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione API manufacturers, exporters, distributors and traders.
click here to find a list of (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione DMF (Drug Master File) is a document detailing the whole manufacturing process of (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione active pharmaceutical ingredient (API) in detail. Different forms of (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione DMFs exist exist since differing nations have different regulations, such as (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione DMF submitted to regulatory agencies in the US is known as a USDMF. (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione USDMF includes data on (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione suppliers with USDMF on PharmaCompass.
We have 8 companies offering (1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0?,?.0?,??.0??,??.0??,??]nonadecane-15,2'-oxolan]-5-ene-5',7-dione
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