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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22512
Submission : 2009-02-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-30
Pay. Date : 2021-06-18
DMF Number : 36029
Submission : 2021-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-06-27
DMF Number : 31848
Submission : 2017-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20651
Submission : 2007-06-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-08
Pay. Date : 2015-12-18
DMF Number : 30093
Submission : 2015-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-02
Pay. Date : 2021-09-20
DMF Number : 36028
Submission : 2021-09-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-18
Pay. Date : 2014-12-24
DMF Number : 29660
Submission : 2015-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-25
Pay. Date : 2017-10-23
DMF Number : 32177
Submission : 2017-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33655
Submission : 2019-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-08-19
DMF Number : 23300
Submission : 2009-11-18
Status : Active
Type : II
Regulatory Info :
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : CAPSULE;ORAL
Brand Name : ACALABRUTINIB
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 216775
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : CAPSULE, EXTENDED RELEAS...
Brand Name : ACETAZOLAMIDE
Dosage Strength : 500MG
Packaging :
Approval Date : 2019-02-19
Application Number : 210423
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : CAPSULE;ORAL
Brand Name : ACITRETIN
Dosage Strength : 10MG
Packaging :
Approval Date : 2024-08-05
Application Number : 217774
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : CAPSULE;ORAL
Brand Name : ACITRETIN
Dosage Strength : 25MG
Packaging :
Approval Date : 2024-08-05
Application Number : 217774
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : CAPSULE;ORAL
Brand Name : ACITRETIN
Dosage Strength : 17.5MG
Packaging :
Approval Date : 2024-08-05
Application Number : 217774
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : OINTMENT;TOPICAL
Brand Name : ACYCLOVIR
Dosage Strength : 5%
Packaging :
Approval Date : 2018-04-06
Application Number : 209000
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : CREAM;TOPICAL
Brand Name : ACYCLOVIR
Dosage Strength : 5%
Packaging :
Approval Date : 2023-11-21
Application Number : 212361
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : GEL;TOPICAL
Brand Name : ADAPALENE
Dosage Strength : 0.3%
Packaging :
Approval Date : 2020-06-18
Application Number : 213508
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : GEL;TOPICAL
Brand Name : ADAPALENE AND BENZOYL PER...
Dosage Strength : 0.3%;2.5%
Packaging :
Approval Date : 2022-08-04
Application Number : 214185
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Alembic Pharmaceuticals Limited
Dosage Form : TABLET;ORAL
Brand Name : ALBENDAZOLE
Dosage Strength : 200MG
Packaging :
Approval Date : 2024-09-04
Application Number : 215652
Regulatory Info : RX
Registration Country : USA
Inspections and registrations
ABOUT THIS PAGE
Alembic Pharmaceuticals Limited is a supplier offers 239 products (APIs, Excipients or Intermediates).
Find a price of Fenofibrate bulk with DMF, CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited
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Find a price of Afatinib bulk with DMF, WC offered by Alembic Pharmaceuticals Limited
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