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 2Sterling 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
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PharmaCompass offers a list of Levonorgestrel API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Levonorgestrel manufacturer or Levonorgestrel supplier for your needs.
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A Mirena manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirena, including repackagers and relabelers. The FDA regulates Mirena manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirena API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Mirena supplier is an individual or a company that provides Mirena active pharmaceutical ingredient (API) or Mirena finished formulations upon request. The Mirena suppliers may include Mirena API manufacturers, exporters, distributors and traders.
click here to find a list of Mirena suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirena DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirena active pharmaceutical ingredient (API) in detail. Different forms of Mirena DMFs exist exist since differing nations have different regulations, such as Mirena USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirena DMF submitted to regulatory agencies in the US is known as a USDMF. Mirena USDMF includes data on Mirena's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirena USDMF is kept confidential to protect the manufacturer’s intellectual property.
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