Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 13M Drug Delivery Systems
03 4Bayer AG
04 1Cipla
05 1FORTEQ NIDAU AG
06 1Formosa Laboratories
07 3Gedeon Richter
08 1Hubei Gedian Humanwell Pharmaceutical
09 1Hunan KYX Pharmaceutical
10 1Indo Phyto Chemicals Private Ltd
11 1Industriale Chimica
12 2Lupin Ltd
13 1Qinhuangdao Zizhu Pharmaceutical
14 2ScinoPharm Taiwan, Ltd
15 1Sterling Spa
16 1Yangzhou Pharmaceutical Factory
17 5Blank
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2014-01-23
DMF Number : 27867
Submission : 2014-01-27
Status :
Type : II
A (-)-Norgestrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (-)-Norgestrel, including repackagers and relabelers. The FDA regulates (-)-Norgestrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (-)-Norgestrel 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 (-)-Norgestrel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (-)-Norgestrel supplier is an individual or a company that provides (-)-Norgestrel active pharmaceutical ingredient (API) or (-)-Norgestrel finished formulations upon request. The (-)-Norgestrel suppliers may include (-)-Norgestrel API manufacturers, exporters, distributors and traders.
click here to find a list of (-)-Norgestrel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (-)-Norgestrel DMF (Drug Master File) is a document detailing the whole manufacturing process of (-)-Norgestrel active pharmaceutical ingredient (API) in detail. Different forms of (-)-Norgestrel DMFs exist exist since differing nations have different regulations, such as (-)-Norgestrel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (-)-Norgestrel DMF submitted to regulatory agencies in the US is known as a USDMF. (-)-Norgestrel USDMF includes data on (-)-Norgestrel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (-)-Norgestrel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (-)-Norgestrel suppliers with USDMF on PharmaCompass.
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