01 1H. Lundbeck AS
01 1GABOXADOL MONOHYDRATE
01 1Denmark
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18417
Submission : 2005-06-09
Status : Active
Type : II
A Thip Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thip Hydrochloride, including repackagers and relabelers. The FDA regulates Thip Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thip Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Thip Hydrochloride supplier is an individual or a company that provides Thip Hydrochloride active pharmaceutical ingredient (API) or Thip Hydrochloride finished formulations upon request. The Thip Hydrochloride suppliers may include Thip Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Thip Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thip Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Thip Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Thip Hydrochloride DMFs exist exist since differing nations have different regulations, such as Thip Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thip Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Thip Hydrochloride USDMF includes data on Thip Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thip Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thip Hydrochloride suppliers with USDMF on PharmaCompass.
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