Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
01 1Bloomage Biotechnology Corp., Ltd
02 1Shandong Freda Biotechnology
01 1ECTOINE
02 1ECTOINE (ECTOINE-200)
01 2China
01 2Active
01 2Blank
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37812
Submission : 2022-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38868
Submission : 2023-09-18
Status : Active
Type : II
A Ectoine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ectoine, including repackagers and relabelers. The FDA regulates Ectoine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ectoine 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 Ectoine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ectoine supplier is an individual or a company that provides Ectoine active pharmaceutical ingredient (API) or Ectoine finished formulations upon request. The Ectoine suppliers may include Ectoine API manufacturers, exporters, distributors and traders.
click here to find a list of Ectoine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ectoine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ectoine active pharmaceutical ingredient (API) in detail. Different forms of Ectoine DMFs exist exist since differing nations have different regulations, such as Ectoine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ectoine DMF submitted to regulatory agencies in the US is known as a USDMF. Ectoine USDMF includes data on Ectoine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ectoine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ectoine suppliers with USDMF on PharmaCompass.
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