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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 Hubei Gedian Humanwell Pharmaceutical (1)

05 Alembic Pharmaceuticals Limited (1)

06 Aurobindo Pharma Limited (1)

07 Beijing Hope Pharmaceutical (1)

08 Beijing Mesochem Technology (1)

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

10 Cipla (1)

11 Fujian South Pharmaceutical (1)

12 Hetero Drugs (1)

13 Laurus Labs (1)

14 MSN Laboratories (2)

15 Olon S.p.A (1)

16 Porton Pharma Solutions (1)

17 Prajna Generics (1)

18 Shandong Haohong Biotechnology Co.,ltd (1)

19 Shanghai Hope Chem (1)

20 Shenzhen HwaGen Pharmaceutical (1)

21 Sichuan Qingmu Pharmaceutical (1)

22 Teva API (1)

23 Vannsh Life Sciences (1)

24 Viatris (1)

25 Zhejiang Tianyu Pharmaceutical Co., Ltd (1)

26 Zydus Lifesciences (1)

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01 China (12)

02 India (13)

03 Israel (1)

04 Italy (1)

05 U.S.A (1)

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01 Active (9)

02 Blank (19)

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01 Blank (28)

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01 Blank (28)

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01 WC-0082 (1)

02 WC-0349 (1)

03 WC-0349A12 (1)

04 WC-0390 (1)

05 Blank (24)

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USDMF

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Written Confirmation

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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
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USDMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
36254
Status
Active
Fees Paid
Reviewed
 
Filing Details
APALUTAMIDE PREMIX
Issue/Submission Date
2021-09-04
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
39029
Status
Active
Fees Paid
N/A
 
Filing Details
APALUTAMIDE
Issue/Submission Date
2023-11-02
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