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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Calyx Chemicals & Pharmaceuticals Limited

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ARTEMETHER

AZITHROMYCIN MONOHYDRATE

CETIRIZINE DIHYDROCHLORIDE

ERYTHROMYCIN

ERYTHROMYCIN ESTOLATE

ERYTHROMYCIN STEARATE

FLUCYTOSINE

HYDROXYZINE HYDROCHLORIDE

IRBESARTAN

ISONIAZID

LOSARTAN POTASSIUM USP

LUMEFANTRINE

MECLIZINE HYDROCHLORIDE

PYRAZINAMIDE USP

VALGANCICLOVIR HYDROCHLORIDE

VALPROIC ACID

ZOPICLONE E.P.

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Status - Active

Status - Inactive

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VALID

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WC-0088

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ARTEMETHER
Issue/Submission Date
2010-07-09
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ARTEMETHER
Issue/Submission Date
2010-07-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AZITHROMYCIN MONOHYDRATE
Issue/Submission Date
2013-09-21
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AZITHROMYCIN MONOHYDRATE
Issue/Submission Date
2013-09-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CETIRIZINE DIHYDROCHLORIDE
Issue/Submission Date
2008-03-06
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CETIRIZINE DIHYDROCHLORIDE
Issue/Submission Date
2008-03-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ERYTHROMYCIN
Issue/Submission Date
2006-12-14
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Erythromycin
Issue/Submission Date
2017-04-07
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0088
Status
Valid - 2019-07-02
Filing Details
Erythromycin (BP/EP/USP)
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-0088
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
ERYTHROMYCIN
Erythromycin
Erythromycin (BP/EP/USP)
Issue/Submission Date
2006-12-14
2017-04-07
2016-07-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ERYTHROMYCIN ESTOLATE
Issue/Submission Date
2007-03-28
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ERYTHROMYCIN ESTOLATE
Issue/Submission Date
2007-03-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ERYTHROMYCIN STEARATE
Issue/Submission Date
2008-10-06
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ERYTHROMYCIN STEARATE
Issue/Submission Date
2008-10-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FLUCYTOSINE
Issue/Submission Date
2010-01-22
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Flucytosine
Issue/Submission Date
2018-02-19
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
FLUCYTOSINE
Flucytosine
Issue/Submission Date
2010-01-22
2018-02-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
HYDROXYZINE HYDROCHLORIDE
Issue/Submission Date
2010-07-22
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
HYDROXYZINE HYDROCHLORIDE
Issue/Submission Date
2010-07-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IRBESARTAN
Issue/Submission Date
2010-07-26
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
IRBESARTAN
Issue/Submission Date
2010-07-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ISONIAZID
Issue/Submission Date
2008-02-07
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Isoniazid
Issue/Submission Date
2019-01-08
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0088
Status
Valid - 2019-07-02
Filing Details
Isoniazid (BP/ EP/USP)
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-0088
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
ISONIAZID
Isoniazid
Isoniazid (BP/ EP/USP)
Issue/Submission Date
2008-02-07
2019-01-08
2016-07-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LOSARTAN POTASSIUM USP
Issue/Submission Date
2008-08-27
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LOSARTAN POTASSIUM USP
Issue/Submission Date
2008-08-27
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LUMEFANTRINE
Issue/Submission Date
2010-07-09
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0088
Status
Valid - 2019-07-02
Filing Details
 Lumefantrine
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-0088
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
LUMEFANTRINE
 Lumefantrine
Issue/Submission Date
2010-07-09
2016-07-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MECLIZINE HYDROCHLORIDE
Issue/Submission Date
2015-04-29
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MECLIZINE HYDROCHLORIDE
Issue/Submission Date
2015-04-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PYRAZINAMIDE USP
Issue/Submission Date
2001-07-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Pyrazinamide
Issue/Submission Date
2018-02-16
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0088
Status
Valid - 2019-07-02
Filing Details
Pyraziramide (BP/EP /USP)
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-0088
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
PYRAZINAMIDE USP
Pyrazinamide
Pyraziramide (BP/EP /USP)
Issue/Submission Date
2001-07-31
2018-02-16
2016-07-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
VALGANCICLOVIR HYDROCHLORIDE
Issue/Submission Date
2012-11-28
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
VALGANCICLOVIR HYDROCHLORIDE
Issue/Submission Date
2012-11-28
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
VALPROIC ACID
Issue/Submission Date
2008-09-12
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
VALPROIC ACID
Issue/Submission Date
2008-09-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ZOPICLONE E.P.
Issue/Submission Date
2001-06-22
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Zopiclone
Issue/Submission Date
2016-10-21
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0088
Status
Valid - 2019-07-02
Filing Details
Zopictone (BP/EP)
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-0088
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
ZOPICLONE E.P.
Zopiclone
Zopictone (BP/EP)
Issue/Submission Date
2001-06-22
2016-10-21
2016-07-19
Supporting Info

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