01 1GE Healthcare Inc
02 2Mallinckrodt Pharmaceuticals
03 1Nordion Canada
04 1PerkinElmer
05 3Blank
01 1CYCLOTRON OPERATION, INDIUM CL (IN 111)
02 1INDIUM CHL IN 111 RADIOCHEM. SOL. AS PRODUCED IN BURLINGAME CA. FACILS
03 1INDIUM IN 111 OXINE
04 1INDIUM-111 CHLORIDE
05 1INDIUM-111 PRODUCED IN NORTH BILLERICA, MASS FACILITIES
06 1INDIUM-III CITRATE ANTIBODY GRADE 7590
07 1PROCEDS & CONTRLS FOR PROCESSING OF INDIUM IN-111(CHL & CITRATE)
08 1TIN-113/INDIUM-113m (DMF FORMERLY HELD BY UNION CARBIDE CORP)
01 1Canada
02 2Ireland
03 1U.S.A
04 1United Kingdom
05 3Blank
01 1Active
02 7Inactive
01 1Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3743
Submission : 1980-03-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5789
Submission : 1985-03-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4374
Submission : 1981-12-21
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-05
Pay. Date : 2019-10-24
DMF Number : 5542
Submission : 1984-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4136
Submission : 1981-04-14
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4244
Submission : 1981-07-31
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1097
Submission : 1967-11-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6393
Submission : 1986-06-04
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Indium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indium, including repackagers and relabelers. The FDA regulates Indium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indium 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 Indium supplier is an individual or a company that provides Indium active pharmaceutical ingredient (API) or Indium finished formulations upon request. The Indium suppliers may include Indium API manufacturers, exporters, distributors and traders.
click here to find a list of Indium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indium DMF (Drug Master File) is a document detailing the whole manufacturing process of Indium active pharmaceutical ingredient (API) in detail. Different forms of Indium DMFs exist exist since differing nations have different regulations, such as Indium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indium DMF submitted to regulatory agencies in the US is known as a USDMF. Indium USDMF includes data on Indium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indium suppliers with USDMF on PharmaCompass.
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