PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
01 1PMC Isochem
02 1Taro Pharmaceutical Industries
03 1Aurobindo Pharma Limited
04 1CTX Lifesciences
05 1Cambrex Corporation
06 1Emcure Pharmaceuticals
07 1Glenmark Life Sciences
08 1Hainan Poly Pharm
09 1Piramal Pharma Solutions
10 1Unichem Laboratories Limited
01 1AMIODARONE HCL
02 1AMIODARONE HCL USP
03 3AMIODARONE HYDROCHLORIDE
04 5AMIODARONE HYDROCHLORIDE USP
01 1China
02 1France
03 5India
04 3U.S.A
01 9Active
02 1Inactive
01 6Complete
02 4Blank
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : Complete
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Pay. Date : 2013-02-13
DMF Number : 7617
Submission : 1988-08-02
Status : Active
Type : II
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Submission : 2001-12-27
Status : Active
Type : II
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DMF Number : 17217
Submission : 2004-03-05
Status : Inactive
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DMF Number : 3505
Submission : 1979-04-11
Status : Active
Type : II
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Pay. Date : 2015-09-11
DMF Number : 25892
Submission : 2012-04-09
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Submission : 2023-05-11
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DMF Review : Complete
Rev. Date : 2019-03-28
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DMF Number : 16787
Submission : 2003-08-27
Status : Active
Type : II
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DMF Review : Complete
Rev. Date : 2021-10-20
Pay. Date : 2021-09-07
DMF Number : 36163
Submission : 2021-09-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-10
DMF Number : 21694
Submission : 2008-06-12
Status : Active
Type : II
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DMF Number : 33688
Submission : 2019-03-22
Status : Active
Type : II
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