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Company profile for Sun Pharmaceutical Industries Limited

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SUN PHARMACEUTICAL INDUSTRIES LIMITED
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About the Company
We were pioneers among Indian pharmaceutical companies to see tremendous value in investing in research & development (R&D). Our early investments in R&D, beginning three decades ago, enabled us to make technology our key differentiator and develop a basket of robust products for diverse markets across the world. Our core strength lies in our ability to excel in developing generics and technologically complex products through ...
We were pioneers among Indian pharmaceutical companies to see tremendous value in investing in research & development (R&D). Our early investments in R&D, beginning three decades ago, enabled us to make technology our key differentiator and develop a basket of robust products for diverse markets across the world. Our core strength lies in our ability to excel in developing generics and technologically complex products through focused teams in formulations, process chemistry and analytical development. We have the capability to deliver quality products within established timelines, at low costs and without compromising on quality.
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Sun Pharmaceutical Industries Limited
Indianew1 Flag
Country
Country
INDIA
Address
Address
Sun House, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063
Telephone
Telephone
+91-22-4324 4324, +91 22 6696 9696
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ListLIST
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USDMF

Found

Application Number
19427
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Issue/Submission Date
2006-05-16
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Gemcitabine hydrochloride
Issue/Submission Date
2015-07-28
Japanese DMF

Found

Application Number
221MF10018
Status
 
Filing Details
GEMCITABINE HYDROCHLORIDE at SUN HO...
Issue/Submission Date
2009-01-28
Written Confirmation

Found

Application Number
Indian CDSCO WC-0159
Status
Valid - 2022-07-25
Filing Details
Gemcitabine Hydrochloride (USP/EP/B...
Issue/Submission Date
2019-12-02
Application Number
19427
221MF10018
Indian CDSCO WC-0159
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2022-07-25
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride
GEMCITABINE HYDROCHLORIDE at SUN HO...
Gemcitabine Hydrochloride (USP/EP/B...
Issue/Submission Date
2006-05-16
2015-07-28
2009-01-28
2019-12-02
See all info for this product

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USDMF

Found

Application Number
19648
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
OXALIPLATIN USP
Issue/Submission Date
2006-08-04
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Oxaliplatin
Issue/Submission Date
2019-11-08
Japanese DMF

Found

Application Number
225MF10220
Status
 
Filing Details
OXALIPLATIN at SUN HOUSE, Plot No. ...
Issue/Submission Date
2013-12-03
Written Confirmation

Found

Application Number
Indian CDSCO WC-0159
Status
Valid - 2022-07-25
Filing Details
Oxaliplatin (USP/EP/BP)
Issue/Submission Date
2019-12-02
Application Number
19648
225MF10220
Indian CDSCO WC-0159
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2022-07-25
Filing Details
OXALIPLATIN USP
Oxaliplatin
OXALIPLATIN at SUN HOUSE, Plot No. ...
Oxaliplatin (USP/EP/BP)
Issue/Submission Date
2006-08-04
2019-11-08
2013-12-03
2019-12-02
See all info for this product

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USDMF

Caution

Application Number
16431
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MESALAMINE USP (5-AMINO SALICYLIC A...
Issue/Submission Date
2003-02-17
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Mesalazine Site II
Issue/Submission Date
2016-12-12
Japanese DMF

Found

Application Number
219MF10100
Status
 
Filing Details
Mesalazine (production only) at SUN...
Issue/Submission Date
2007-03-14
Written Confirmation

Found

Application Number
Indian CDSCO WC-0159
Status
Valid - 2022-07-25
Filing Details
Mesalamine/Mesalazine (USP/EP/BP)
Issue/Submission Date
2019-12-02
Application Number
16431
219MF10100
Indian CDSCO WC-0159
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2022-07-25
Filing Details
MESALAMINE USP (5-AMINO SALICYLIC A...
Mesalazine Site II
Mesalazine (production only) at SUN...
Mesalamine/Mesalazine (USP/EP/BP)
Issue/Submission Date
2003-02-17
2016-12-12
2007-03-14
2019-12-02
See all info for this product

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USDMF

Found

Application Number
16174
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FLUVOXAMINE MALEATE USP
Issue/Submission Date
2002-09-24
CEP/COS

Close

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Found

Application Number
221MF10042
Status
 
Filing Details
FLUVOXAMINE MALEATE at SUN HOUSE, P...
Issue/Submission Date
2009-02-23
Written Confirmation

Found

Application Number
Indian CDSCO WC-0159
Status
Valid - 2022-07-25
Filing Details
Fluvoxamine Maleate (BP/USP)
Issue/Submission Date
2019-12-02
Application Number
16174
221MF10042
Indian CDSCO WC-0159
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2022-07-25
Filing Details
FLUVOXAMINE MALEATE USP
FLUVOXAMINE MALEATE at SUN HOUSE, P...
Fluvoxamine Maleate (BP/USP)
Issue/Submission Date
2002-09-24
2009-02-23
2019-12-02
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USDMF

Found

Application Number
15612
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
METFORMIN HYDROCHLORIDE USP
Issue/Submission Date
2001-08-25
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Metformin Hydrochloride Xylene proc...
Issue/Submission Date
2016-10-05
Japanese DMF

Close

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Found

Application Number
Indian CDSCO WC-0159
Status
Valid - 2022-07-25
Filing Details
Metformin Hydrochloride (USP/EP/BP)
Issue/Submission Date
2019-12-02
Application Number
15612
Indian CDSCO WC-0159
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2022-07-25
Filing Details
METFORMIN HYDROCHLORIDE USP
Metformin Hydrochloride Xylene proc...
Metformin Hydrochloride (USP/EP/BP)
Issue/Submission Date
2001-08-25
2016-10-05
2019-12-02
See all info for this product

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USDMF

Found

Application Number
15995
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
METOPROLOL TARTRATE USP
Issue/Submission Date
2002-05-18
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Metoprolol tartrate Site II
Issue/Submission Date
2020-05-29
Japanese DMF

Close

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Found

Application Number
Indian CDSCO WC-243
Status
Valid - 2022-09-10
Filing Details
Metoprolol Tartrate (EP/BP/USP)
Issue/Submission Date
2019-09-11
Application Number
15995
Indian CDSCO WC-243
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2022-09-10
Filing Details
METOPROLOL TARTRATE USP
Metoprolol tartrate Site II
Metoprolol Tartrate (EP/BP/USP)
Issue/Submission Date
2002-05-18
2020-05-29
2019-09-11
See all info for this product

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USDMF

Found

Application Number
16113
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MIRTAZAPINE USP [HEMIHYDRATE]
Issue/Submission Date
2002-08-22
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Mirtazapine
Issue/Submission Date
2018-04-05
Japanese DMF

Close

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Found

Application Number
Indian CDSCO WC-0168
Status
Valid - 2022-07-14
Filing Details
Mirtazapine (EP/BP/USP)
Issue/Submission Date
2019-07-15
Application Number
16113
Indian CDSCO WC-0168
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2022-07-14
Filing Details
MIRTAZAPINE USP [HEMIHYDRATE]
Mirtazapine
Mirtazapine (EP/BP/USP)
Issue/Submission Date
2002-08-22
2018-04-05
2019-07-15
See all info for this product

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USDMF

Found

Application Number
16562
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ONDANSETRON HYDROCHLORIDE USP
Issue/Submission Date
2003-04-23
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Ondansetron hydrochloride dihydrate
Issue/Submission Date
2015-07-28
Japanese DMF

Close

Application Number
Status
 
Filing Details
Issue/Su