01 1INTERNATIONAL SPECIALTY PRODUCTS
02 1ISP Chemicals, LLC
03 1Tecoland Corporation
04 1Zhejiang Supor Pharmaceuticals Co., LTD
01 1China
02 3U.S.A
01 2Active
02 2Blank
01 4Blank
01 1224MF10186
02 3Blank
01 4Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9007
Submission : 1991-03-07
Status : Active
Type : II
NDC Package Code : 21222-002
Start Marketing Date : 2012-07-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23947
Submission : 2010-06-14
Status : Active
Type : II
NDC Package Code : 14799-2009
Start Marketing Date : 2010-08-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 224MF10186
Registrant's Address : 8145 Blazer Drive, Wilmington, DE, 19808, United States
Initial Date of Registration : 2012-09-03
Latest Date of Registration : --
A Mitotane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitotane, including repackagers and relabelers. The FDA regulates Mitotane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitotane 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 Mitotane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitotane supplier is an individual or a company that provides Mitotane active pharmaceutical ingredient (API) or Mitotane finished formulations upon request. The Mitotane suppliers may include Mitotane API manufacturers, exporters, distributors and traders.
click here to find a list of Mitotane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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