Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1ACS DOBFAR SPA
03 1Curia
04 1Fujifilm Diosynth Biotechnologies
05 1Henan Lihua Pharmaceutical
06 1Hovione
07 1Mahima Life Sciences
08 1Quimica Sintetica
09 1SIMS Srl
10 1Blank
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-25
Pay. Date : 2023-10-03
DMF Number : 37466
Submission : 2022-09-09
Status :
Type : II
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A CELESTONE SOLUSPAN-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CELESTONE SOLUSPAN-1, including repackagers and relabelers. The FDA regulates CELESTONE SOLUSPAN-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CELESTONE SOLUSPAN-1 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 CELESTONE SOLUSPAN-1 supplier is an individual or a company that provides CELESTONE SOLUSPAN-1 active pharmaceutical ingredient (API) or CELESTONE SOLUSPAN-1 finished formulations upon request. The CELESTONE SOLUSPAN-1 suppliers may include CELESTONE SOLUSPAN-1 API manufacturers, exporters, distributors and traders.
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A CELESTONE SOLUSPAN-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of CELESTONE SOLUSPAN-1 active pharmaceutical ingredient (API) in detail. Different forms of CELESTONE SOLUSPAN-1 DMFs exist exist since differing nations have different regulations, such as CELESTONE SOLUSPAN-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CELESTONE SOLUSPAN-1 DMF submitted to regulatory agencies in the US is known as a USDMF. CELESTONE SOLUSPAN-1 USDMF includes data on CELESTONE SOLUSPAN-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CELESTONE SOLUSPAN-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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