Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 2Symbiotec Pharmalab
02 1ACS DOBFAR SPA
03 1Aurisco Pharmaceutical
04 2Bayer AG
05 1Fujifilm Diosynth Biotechnologies
06 1Henan Lihua Pharmaceutical
07 1Mahima Life Sciences
08 1Merck & Co
09 1Pfizer Inc
10 1Quimica Sintetica
11 1SIMS Srl
12 2Tianjin Tianfa Pharmaceutical Import & Export
13 1Xi'an Guokang Ruijin Pharmaceutical
14 2Blank
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-13
Pay. Date : 2014-04-29
DMF Number : 25197
Submission : 2011-08-10
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-25
Pay. Date : 2023-10-05
DMF Number : 36086
Submission : 2022-07-21
Status :
Type : II
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A Celestene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Celestene, including repackagers and relabelers. The FDA regulates Celestene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Celestene 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 Celestene supplier is an individual or a company that provides Celestene active pharmaceutical ingredient (API) or Celestene finished formulations upon request. The Celestene suppliers may include Celestene API manufacturers, exporters, distributors and traders.
click here to find a list of Celestene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Celestene DMF (Drug Master File) is a document detailing the whole manufacturing process of Celestene active pharmaceutical ingredient (API) in detail. Different forms of Celestene DMFs exist exist since differing nations have different regulations, such as Celestene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Celestene DMF submitted to regulatory agencies in the US is known as a USDMF. Celestene USDMF includes data on Celestene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Celestene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Celestene suppliers with USDMF on PharmaCompass.
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