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List of Written Confirmation(s) issued for wc-0082 Active Pharmaceutical Ingredient (API)

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M/s. Alembic Pharmaceuticals Limited

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Apixaban (IH)

Asenapine Maleate (IH)

Axitinib OH)

Azilsartan Medoxomil Monopotassium (IH)

Bazedoxifene Acetate IH

Bosentan

Canagliflozin IH

Dabigatran Etexilate Mesylate

Dapagliflozin IH

Darifenacin Hydrobrbmide

Donepezil Hydrochloride

Dronedarone Hydrochloride

Duloxetine Hydrochloride (Ph. Eur.)

Empagliflozin IH

Febuxostat

Felodipine (EP)

Ivacaftor IH

Minodronic Acid Hydrates IH

Modafinil EP

Pramipexole Dihydrochloride Monohydrate (EP)

Prasugrel (IH)

Prasugrel Hydrochloride

Pregabalin (EP)

Rabeprazole Sodium

Riociguat IH

Rivaroxaban

Ropinirole Hydrochloride (USP)

Solifenacin Succinate (EP)

Sorafenib Tosylate (IH)

Tadalafil (Ph Eur.)

Ticagrelor (IH)

Vardenafil Hydrochloride Trihydrate

Vilazodone HCl IH

Warfarin Sodium (EP)

Zolmitriptan

lloperidone

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WC-0082

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India

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WC-0082
API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
2025-07-02
2022-06-17
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API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
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API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
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WC-0082
API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
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API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
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WC-0082
API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
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API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
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API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
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API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
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Looking for Written Confirmation Application Number wc-0082

Looking for Written Confirmation Application Number wc-0082 36

19

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Rivaroxaban, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

18

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Asenapine Maleate (IH), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

17

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Ivacaftor IH, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

16

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Duloxetine Hydrochloride (Ph. Eur.), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

15

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Minodronic Acid Hydrates IH, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

14

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Dapagliflozin IH, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

13

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Dronedarone Hydrochloride, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

12

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Axitinib OH), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

11

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Dabigatran Etexilate Mesylate, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

10

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Prasugrel (IH), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

9

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Riociguat IH, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

8

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Tadalafil (Ph Eur.), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

7

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Felodipine (EP), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

6

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Empagliflozin IH, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

5

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is lloperidone, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

4

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Pregabalin (EP), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

3

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Rabeprazole Sodium, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

2

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Ticagrelor (IH), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

1

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Modafinil EP, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

0

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Bosentan, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-1

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Ropinirole Hydrochloride (USP), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-2

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Warfarin Sodium (EP), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-3

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Darifenacin Hydrobrbmide, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-4

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Azilsartan Medoxomil Monopotassium (IH), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-5

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Vilazodone HCl IH, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-6

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Prasugrel Hydrochloride, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-7

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Solifenacin Succinate (EP), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-8

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Donepezil Hydrochloride, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-9

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Apixaban (IH), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-10

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Pramipexole Dihydrochloride Monohydrate (EP), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-11

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Bazedoxifene Acetate IH, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-12

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Febuxostat, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-13

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Vardenafil Hydrochloride Trihydrate, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-14

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Canagliflozin IH, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-15

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Zolmitriptan, with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

-16

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is Sorafenib Tosylate (IH), with a corresponding application number wc-0082.

and Date of Issue 2022-06-17

and Valid Till 2025-07-02

and Address of the Firm API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India

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