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List of Written Confirmation(s) issued for Quetiapine Active Pharmaceutical Ingredient (API)

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01 1M/s. ZCL Chemicals Limited

02 1M/s Dr. Reddy's Laboratories

03 1M/s. Aarti Pharmalabs Limited

04 2M/s Megafine Pharma (P) Limited

05 1Divi’s Laboratories

06 1M/s Dishman Carbogen Amcis

07 1M/s Divis Laboratories

08 1M/s Hetero Drugs Limited

09 1M/s Jubilant Pharmova Limited

10 1M/s NIFTY LABS PVT

11 1M/s Nifty Labs Pvt.Ltd

12 1M/s Teva API India Private Limited

13 1M/s Teva API India Pvt ltd

14 1M/s Unichem laboratories limited

15 1M/s Vasudha Pharma Chem limited

16 1M/s. Alembic Pharmaceuticals Limited,

17 1M/s. Aurobindo Pharma Ltd., (Unit-XI), 

18 1M/s. Cadila Healthcare Limited, 

19 1M/s. Dishman Carbogen Amcis

20 1M/s. Hetero Labs Limited.,

21 1M/s. Hetro Labs Limited

22 1M/s. Ind- Swift Laboratories Limited

23 1M/s. Indoco Remedies Ltd.,

24 1M/s. Lupin Ltd

25 1M/s. Macleods Pharmaceuticals Ltd.

26 2M/s. Mylan Laboratories Ltd., 

27 1M/s. Nosch Labs Pvt Ltd

28 1M/s. Nosch Labs Pvt Ltd.

29 1M/s. Olon Active Pharmaceuticals India Private Limited

30 1M/s. Sun Pharmaceuticals Industries Ltd.

31 1M/s. Unichem Lab. Ltd.,

32 1M/s. Vasudha Pharma Chem Limited.

33 1M/s.  Hikal Ltd 

34 1M/s.  IPCA Laboratories Ltd., 

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Quetiapine Fumarate BP/EP/USP

Date of Issue : 2022-08-25

Valid Till : 2025-07-02

Written Confirmation Number : WC-0195

Address of the Firm : Plot No. 3102/B, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat I...

Cohance

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Quetiapine Fumarate EP/USP

Date of Issue : 2022-06-17

Valid Till : 2025-07-07

Written Confirmation Number : WC-0067

Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

Quetiapine Fumarate IH/EP/USP

Date of Issue : 2023-01-06

Valid Till : 2025-07-29

Written Confirmation Number : WC-0099

Address of the Firm : Plot No. E-50, Unit-IV, MIDC, Tarapur - 401506, Taluka: Palghar, District: Thane...

Aarti Industries Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

Quetiapine Fumarate USP/IP/Ph.Eur/IH

Date of Issue : 2023-06-26

Valid Till : 2026-06-26

Written Confirmation Number : WC-0462

Address of the Firm : Plot No. 911-912, Phase-lll, G.I.D.C, Vapi-396195, Dist Valsad, Gujarat

Megafine Pharma

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

Quetiapine Hemifumarate IH/EP/USP

Date of Issue : 2022-07-27

Valid Till : 2025-07-21

Written Confirmation Number : WC-0087-(Annexure-1)

Address of the Firm : Plot No.1 to 5, 31 to 35 & 48 to 51, 26 & K/201, Village Lakhmapur, Taluka Dindo...

Megafine Pharma

06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Quetiapine Fumarate (IH)

Date of Issue : 2022-09-16

Valid Till : 2025-08-08

Written Confirmation Number : WC-0041

Address of the Firm : Unit-I, Survey No.10, I.D.A, Gaddapotharam Village, Jinnaram Mandal,Medak Dist, ...

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07

AAPS 2024
Not Confirmed
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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Quetiapine Fumarate (EP)

Date of Issue : 2022-05-02

Valid Till : 2025-07-25

Written Confirmation Number : WC-0027

Address of the Firm : Unit-II, Survey No.14, IDA Gaddapotharam (Village), Kazipally, Jinnaram (Mandal)...

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10

AAPS 2024
Not Confirmed
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