EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Supriya Lifescience
03 1Blank
01 1HYDROXOCOBALAMIN
02 1HYDROXOCOBALAMIN BASE
03 1HYDROXOCOBALAMIN USP
01 1France
02 1India
03 1Blank
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18216
Submission : 2005-03-30
Status : Active
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37168
Submission : 2022-06-04
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9100
Submission : 1991-05-06
Status : Inactive
Type : II
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A Hydroxocobalamin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxocobalamin, including repackagers and relabelers. The FDA regulates Hydroxocobalamin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxocobalamin 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 Hydroxocobalamin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxocobalamin supplier is an individual or a company that provides Hydroxocobalamin active pharmaceutical ingredient (API) or Hydroxocobalamin finished formulations upon request. The Hydroxocobalamin suppliers may include Hydroxocobalamin API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxocobalamin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxocobalamin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxocobalamin active pharmaceutical ingredient (API) in detail. Different forms of Hydroxocobalamin DMFs exist exist since differing nations have different regulations, such as Hydroxocobalamin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxocobalamin DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxocobalamin USDMF includes data on Hydroxocobalamin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxocobalamin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxocobalamin suppliers with USDMF on PharmaCompass.
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