Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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05 1TAPI Technology & API Services
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11 1Cipla
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01 11China
02 13India
03 1Israel
04 1U.S.A
01 11Active
02 15Blank
01 26Blank
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01 1WC-0082
02 1WC-0349
03 1WC-0349A12
04 1WC-0390
05 22Blank
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-28
Pay. Date : 2020-09-30
DMF Number : 34667
Submission : 2020-03-24
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm :
NDC Package Code : 71796-019
Start Marketing Date : 2020-03-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : BR |
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39029
Submission : 2023-11-02
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35740
Submission : 2021-03-25
Status : Active
Type : II
NDC Package Code : 71796-019
Start Marketing Date : 2020-03-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : BR |
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-29
Pay. Date : 2021-11-17
DMF Number : 36394
Submission : 2021-11-24
Status : Active
Type : II
NDC Package Code : 68554-0127
Start Marketing Date : 2018-02-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-10
Pay. Date : 2021-09-24
DMF Number : 34711
Submission : 2020-03-31
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0100
Start Marketing Date : 2020-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-29
Pay. Date : 2021-12-07
DMF Number : 36264
Submission : 2021-09-09
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-25
Pay. Date : 2021-09-03
DMF Number : 36254
Submission : 2021-09-04
Status : Active
Type : II
NDC Package Code : 59651-614
Start Marketing Date : 2024-01-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (12.5kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-29
Pay. Date : 2021-08-19
DMF Number : 36165
Submission : 2021-09-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39890
Submission : 2024-05-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40362
Submission : 2024-08-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-02
Pay. Date : 2021-09-20
DMF Number : 36028
Submission : 2021-09-22
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
Date of Issue : 2021-04-23
Valid Till : 2022-05-05
Written Confirmation Number : WC-0349A12
Address of the Firm :
NDC Package Code : 54893-0100
Start Marketing Date : 2020-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Apalutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apalutamide, including repackagers and relabelers. The FDA regulates Apalutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apalutamide 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 Apalutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apalutamide supplier is an individual or a company that provides Apalutamide active pharmaceutical ingredient (API) or Apalutamide finished formulations upon request. The Apalutamide suppliers may include Apalutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Apalutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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