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Bora CDMO Bora CDMO

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Praveen Laboratories Pvt Ltd

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01 300543-56-0 (1)

02 Cetirizine Dihydrochloride (1)

03 Clopidogrel (2)

04 Lamotrigine (1)

05 Levocetirizine Dihydrochloride (1)

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01 Active (1)

02 Blank (5)

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01 Valid (2)

02 Blank (4)

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01 Blank (6)

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01 WC-0193 (4)

02 Blank (2)

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USDMF

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CEP/COS

Found CEP/COS

CEP 2014-176 - Rev 01
Valid
Clopidogrel hydrogen sulfate
2024-02-20
Japanese DMF

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Written Confirmation

Caution WC

Indian CDSCO WC-0193
Expired
Clopidogrel Bisulfate (USP)/Clopido...
2019-09-09
Application Number
Indian CDSCO WC-0193
Status
Valid
 
Expired
2022-09-08
Filing Details
Clopidogrel hydrogen sulfate
Clopidogrel Bisulfate (USP)/Clopido...
Issue/Submission Date
2024-02-20
2019-09-09
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USDMF

Found USDMF

22842
Active
(R)-[1-(4 CHLOROPHENYL) PHENYL METH...
2009-06-09
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
22842
Status
Active
Fees Unpaid
N/A
 
Filing Details
(R)-[1-(4 CHLOROPHENYL) PHENYL METH...
Issue/Submission Date
2009-06-09
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2017-247 - Rev 00
Valid
Clopidogrel hydrogen sulfate, Proce...
2022-12-19
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Clopidogrel hydrogen sulfate, Proce...
Issue/Submission Date
2022-12-19
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Indian CDSCO WC-0193
Expired
Cetirizine dihydrochloride BP/EP/US...
2019-09-09
Application Number
Indian CDSCO WC-0193
Status
 
Expired
2022-09-08
Filing Details
Cetirizine dihydrochloride BP/EP/US...
Issue/Submission Date
2019-09-09
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Indian CDSCO WC-0193
Expired
Lamotrigine (Ph.Eur/BP/USP)
2019-09-09
Application Number
Indian CDSCO WC-0193
Status
 
Expired
2022-09-08
Filing Details
Lamotrigine (Ph.Eur/BP/USP)
Issue/Submission Date
2019-09-09
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Indian CDSCO WC-0193
Expired
Levocetirizine Dihydrochloride IH/U...
2019-09-09
Application Number
Indian CDSCO WC-0193
Status
 
Expired
2022-09-08
Filing Details
Levocetirizine Dihydrochloride IH/U...
Issue/Submission Date
2019-09-09
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