01 1Laboratorio Chimico Internazionale Spa
02 1Olon S.p.A
03 1SHANDONG LUNING PHARMACEUTICAL CO., LTD
04 1SIGMA TAU
01 2ALPHA LIPOIC ACID
02 1DL-6,8-THIOTIC ACID, OXIDIZED FORM CLINICAL STUDIES BY DR. R. JACOBSON
03 1THIOCTIC ACID
01 1China
02 2Italy
03 1U.S.A
01 3Active
02 1Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18998
Submission : 2005-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22211
Submission : 2008-11-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37398
Submission : 2023-08-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4261
Submission : 1981-08-28
Status : Inactive
Type : II
A Biletan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biletan, including repackagers and relabelers. The FDA regulates Biletan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biletan 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 Biletan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biletan supplier is an individual or a company that provides Biletan active pharmaceutical ingredient (API) or Biletan finished formulations upon request. The Biletan suppliers may include Biletan API manufacturers, exporters, distributors and traders.
click here to find a list of Biletan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Biletan DMF (Drug Master File) is a document detailing the whole manufacturing process of Biletan active pharmaceutical ingredient (API) in detail. Different forms of Biletan DMFs exist exist since differing nations have different regulations, such as Biletan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Biletan DMF submitted to regulatory agencies in the US is known as a USDMF. Biletan USDMF includes data on Biletan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Biletan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Biletan suppliers with USDMF on PharmaCompass.
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