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List of Written Confirmation(s) issued for wc-0014 Active Pharmaceutical Ingredient (API)

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M/s. Natco Pharma Ltd, 

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Ambrisentan IH

Anastrazole EP

Apixaban IH

Armodafinil (IH)

Bosentan Monohydrate (IH)

Chloroquine Phosphate USP

Citalopram Hydrobromide (USP/Ph. Eur.)

Dabigatran etexilate mesilate IH

Erlotinib Hydrochloride (IH)

Gefitinib (IH)

Glatiramer Acetate (IH)

Granisetron Hydrochloride (USP/Ph. Eur.)

Ibandronate Sodium Monohydrate (IH)

Lansoprazole (USP/Ph. Eur.)

Lanthanum Carbonate Dihydrate (IH)

Ledipasvir (IH)

Letrozole (USP/Ph. Eur.)

Ondansetron Hydrochloride (USP)/Ondansetron Hydrochloride Dihydrate (Ph. Eur.)

Regorafenib IH

Rizatriptan Bezoate (IH/USP/Ph. Eur.)

Salmeterol Xinafoate (USP/Ph. Eur.)

Sertraline Hydrochloride (IH/USP/Ph. Eur.)

Sorafenib Tosylate (IH)

Sugammadex Sodium IH

Teriflunomide IH

Trihexyphenidyl Hydrochloride (USP/Ph.Eur.)

Zoledronic Acid (IH)

Zolmitriptan (IH) ITEM(S)

lmatinib Mesylate (IH/Ph. Eur.)

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WC-0014

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India

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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
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2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
2022-06-25
2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
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2019-06-26
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WC-0014
Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
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2019-06-26
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WC-0014
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2019-06-26
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Looking for Written Confirmation Application Number wc-0014

Looking for Written Confirmation Application Number wc-0014 29

19

Natco Pharma 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 Anastrazole EP, with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

18

Natco Pharma 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 Teriflunomide IH, with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

17

Natco Pharma 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 Granisetron Hydrochloride (USP/Ph. Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

16

Natco Pharma 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 Lanthanum Carbonate Dihydrate (IH), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

15

Natco Pharma 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-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

14

Natco Pharma 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 Armodafinil (IH), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

13

Natco Pharma 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 Gefitinib (IH), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

12

Natco Pharma 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 Glatiramer Acetate (IH), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

11

Natco Pharma 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 Ledipasvir (IH), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

10

Natco Pharma 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 Trihexyphenidyl Hydrochloride (USP/Ph.Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

9

Natco Pharma 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 Monohydrate (IH), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

8

Natco Pharma 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 Ibandronate Sodium Monohydrate (IH), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

7

Natco Pharma 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 mesilate IH, with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

6

Natco Pharma 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 Ondansetron Hydrochloride (USP)/Ondansetron Hydrochloride Dihydrate (Ph. Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

5

Natco Pharma 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 Zoledronic Acid (IH), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

4

Natco Pharma 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 Citalopram Hydrobromide (USP/Ph. Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

3

Natco Pharma 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 lmatinib Mesylate (IH/Ph. Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

2

Natco Pharma 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 Rizatriptan Bezoate (IH/USP/Ph. Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

1

Natco Pharma 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 Ambrisentan IH, with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

0

Natco Pharma 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-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

-1

Natco Pharma 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 (IH) ITEM(S), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

-2

Natco Pharma 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 Lansoprazole (USP/Ph. Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

-3

Natco Pharma 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 Salmeterol Xinafoate (USP/Ph. Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

-4

Natco Pharma 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 Chloroquine Phosphate USP, with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

-5

Natco Pharma 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 Regorafenib IH, with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

-6

Natco Pharma 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 Sugammadex Sodium IH, with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

-7

Natco Pharma 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 Erlotinib Hydrochloride (IH), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

-8

Natco Pharma 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 Letrozole (USP/Ph. Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

-9

Natco Pharma 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 Sertraline Hydrochloride (IH/USP/Ph. Eur.), with a corresponding application number wc-0014.

and Date of Issue 2019-06-26

and Valid Till 2022-06-25

and Address of the Firm Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

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