Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
01 1Pfizer CentreOne
02 1Symbiotec Pharmalab
03 1Bayer AG
04 1F. Hoffmann-La Roche
05 1Fujifilm Diosynth Biotechnologies
06 2Henan Lihua Pharmaceutical
07 1Jiangsu Lianhuan Pharmaceutical
08 1Reliable Biopharmaceutical Corporation
09 2Shandong Xinhua Pharmaceutical
10 1Tianjin Jinjin Pharmaceutical Co Ltd
11 1Yangzhou Pharmaceutical
12 2Blank
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-18
Pay. Date : 2013-02-14
DMF Number : 5498
Submission : 1984-06-11
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-15
Pay. Date : 2016-10-27
DMF Number : 30820
Submission : 2016-08-05
Status :
Type : II
A Hydrocortisone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrocortisone Acetate, including repackagers and relabelers. The FDA regulates Hydrocortisone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrocortisone Acetate 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 Hydrocortisone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrocortisone Acetate supplier is an individual or a company that provides Hydrocortisone Acetate active pharmaceutical ingredient (API) or Hydrocortisone Acetate finished formulations upon request. The Hydrocortisone Acetate suppliers may include Hydrocortisone Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrocortisone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydrocortisone Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydrocortisone Acetate active pharmaceutical ingredient (API) in detail. Different forms of Hydrocortisone Acetate DMFs exist exist since differing nations have different regulations, such as Hydrocortisone Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydrocortisone Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydrocortisone Acetate USDMF includes data on Hydrocortisone Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydrocortisone Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydrocortisone Acetate suppliers with USDMF on PharmaCompass.
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