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List of Written Confirmation(s) issued for wc-0213 Active Pharmaceutical Ingredient (API)

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M/s. Laurus Labs Pvt. Ltd.,

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Abacavir IH

Abacavir Sulfate (USP/IH/Ph. Eur/Ph. Int)

Atazanavir Sulphate (IH)

Azacitidine (IH)

Bortezomib (IH)

Capecitabine (USP/IP)

Carflizomib (IH)

Darunavir (IH)

Darunavir Ethanolate (IH)

Efavirenz (USP/IH/Ph.Int)

Emtricitabine (IH/ Ph.lnt)

Erlotinib Hydrochloride (IH)

Gemcitabine Hydrchloride (USP/BP/IH/Ph. Eur.)

Imatinib Mesylate (IH)

Irinotecan Hydrochloride Trihydrate (USP/IH)

Lamivudine (USP/BP/Ph. Eur/Ph.Int)

Lenalidomide (IH)/Lenalidomide HCL Monohydrate (IH)

Metformin Hydrochloride (IP/USP/Ph.Eur/BP/JP/IH)

Montelukast Sodium (USP/IH/Ph. Eur.)

Nevirapine (USP/IH/Ph. Eur/Ph. Int/BP)

Raltegravir Potassium IH

Sofosbuvir (IH)

Temozolamide

Tenofovir Disoproxil Phosphate (IH)

Tenofovir Disoproxil Succinate (IH)

Thalidomide (USP/IH)

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WC-0213

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India

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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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WC-0213
Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
2025-07-02
2023-07-03
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Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
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Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
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Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
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Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
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2023-07-03
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Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
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2025-07-02
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First
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Looking for Written Confirmation Application Number wc-0213

Looking for Written Confirmation Application Number wc-0213 26

19

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Darunavir Ethanolate (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

18

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Montelukast Sodium (USP/IH/Ph. Eur.), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

17

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Lenalidomide (IH)/Lenalidomide HCL Monohydrate (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

16

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Efavirenz (USP/IH/Ph.Int), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

15

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Erlotinib Hydrochloride (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

14

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Abacavir IH, with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

13

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Azacitidine (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

12

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Nevirapine (USP/IH/Ph. Eur/Ph. Int/BP), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

11

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Thalidomide (USP/IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

10

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Emtricitabine (IH/ Ph.lnt), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

9

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Bortezomib (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

8

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Temozolamide, with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

7

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Tenofovir Disoproxil Phosphate (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

6

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Gemcitabine Hydrchloride (USP/BP/IH/Ph. Eur.), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

5

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Darunavir (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

4

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Tenofovir Disoproxil Succinate (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

3

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Irinotecan Hydrochloride Trihydrate (USP/IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

2

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Metformin Hydrochloride (IP/USP/Ph.Eur/BP/JP/IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

1

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Sofosbuvir (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

0

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Imatinib Mesylate (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

-1

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Carflizomib (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

-2

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Lamivudine (USP/BP/Ph. Eur/Ph.Int), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

-3

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Capecitabine (USP/IP), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

-4

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Abacavir Sulfate (USP/IH/Ph. Eur/Ph. Int), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

-5

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Atazanavir Sulphate (IH), with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

-6

Laurus Labs, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is Raltegravir Potassium IH, with a corresponding application number wc-0213.

and Date of Issue 2023-07-03

and Valid Till 2025-07-02

and Address of the Firm Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India

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