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List of all Manufacturers, Suppliers & Exporters of Apalutamide API listed on PharmaCompass with details of regulatory filings

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01 Aarti Pharmalabs (1)

02 Dr. Reddy's Laboratories (2)

03 Shandong Chenghui Shuangda Pharmaceutical (1)

04 Beijing Mesochem Technology (1)

05 Alembic Pharmaceuticals Limited (1)

06 Aurobindo Pharma Limited (1)

07 Beijing Hope Pharmaceutical (1)

08 BrightGene Bio-Medical Technology Co.,Ltd (1)

09 Cipla (1)

10 Egis Pharmaceuticals PLC (1)

11 Fujian South Pharmaceutical (1)

12 Hetero Drugs (1)

13 Laurus Labs (1)

14 MSN Laboratories (1)

15 Olon S.p.A (1)

16 Prajna Generics (1)

17 Shandong Haohong Biotechnology Co.,ltd (1)

18 Shanghai Hope Chem (1)

19 Shenzhen HwaGen Pharmaceutical (1)

20 Sichuan Qingmu Pharmaceutical (1)

21 Teva API (1)

22 Vannsh Life Sciences (1)

23 Viatris (1)

24 Zhejiang Tianyu Pharmaceutical Co., Ltd (1)

25 Zydus Lifesciences (1)

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01 China (10)

02 Hungary (1)

03 India (12)

04 Israel (1)

05 Italy (1)

06 U.S.A (1)

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01 Active (8)

02 Blank (18)

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01 Blank (26)

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01 Blank (26)

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01 WC-0349A12 (1)

02 WC-0390 (1)

03 Blank (24)

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Application Number
Status
 
Filing Details
Issue/Submission Date
Aarti Industries Company Banner

DDL 2023

Not Confirmed

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USDMF

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Written Confirmation

Found WC

Application Number
34667
Indian CDSCO WC-0390
Status
Active
Fees Paid
Reviewed
 
Valid
2025-11-30
Filing Details
APALUTAMIDE
Apalutamide IH
Issue/Submission Date
2020-03-24
2022-07-28
Dr Reddy Company Banner

DDL 2023

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Beijing Mesochem Technology CB

DDL 2023

Not Confirmed

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USDMF

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CEP/COS

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Application Number
35740
Status
Active
Fees Paid
N/A
 
Filing Details
APALUTAMIDE (AMORPHOUS)
Issue/Submission Date
2021-03-25
Dr Reddy Company Banner

DDL 2023

Not Confirmed

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USDMF

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CEP/COS

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Written Confirmation

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Application Number
36028
Status
Active
Fees Paid
Reviewed
 
Filing Details
APALUTAMIDE
Issue/Submission Date
2021-09-22
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USDMF

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Written Confirmation

Caution WC

Application Number
34711
Indian CDSCO WC-0349A12
Status
Active
Fees Paid
Reviewed
 
Expired
2022-05-05
Filing Details
APALUTAMIDE
Apalutamide IH
Issue/Submission Date
2020-03-31
2021-04-23
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USDMF

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CEP/COS

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Application Number
36264
Status
Active
Fees Paid
Reviewed
 
Filing Details
APALUTAMIDE
Issue/Submission Date
2021-09-09
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