Formulations Product List

Form-25 Licenses for Domestic and Export

S.No. Product name Therapeutic Use
1 Apixaban tablets 2.5 mg Anti-coagulant (heart disease)
2 Apixaban tablets 5 mg Anti-coagulant (heart disease)
3 Atenolol Tablets IP 50 mg Blood Pressure
4 Atenolol Tablets IP 100 mg Blood Pressure
5 Atorvastatin Calcium Tablets 10 mg Cholesterol
6 Atorvastatin Calcium Tablets 20 mg Blood Pressure
7 Atorvastatin Calcium Tablets 40 mg Cholesterol
8 Atorvastatin Calcium Tablets 80 mg Cholesterol
9 Divalproex Sodium Extended-Release Tablets IP 500 mg Epilepsy
10 Empagliflozin tablets 10 mg Diabetes
11 Empagliflozin tablets 25 mg Diabetes
12 Esomeprazole Delayed Release Tablets IP 20 mg Acidity
13 Esomeprazole Delayed Release Tablets IP 40 mg Acidity
14 Hydroxychloroquine sulphate tablets 300 mg Rheumatoid arthritis
15 Hydroxychloroquine sulphate tablets 400 mg Rheumatoid arthritis
16 Hydroxychloroquine sulphate tablets IP 200 mg Rheumatoid arthritis
17 Linagliptin and Metformin Hydrochloride Tablets 2.5 mg and 500 mg Diabetes
18 Linagliptin and Metformin Hydrochloride Tablets 2.5 mg and 850 mg Diabetes
19 Linagliptin and Metformin Hydrochloride Tablets 2.5 mg and 1000 mg Diabetes
20 Linagliptin tablets 5 mg Diabetes
21 Metoprolol Succinate Extended-Release Tablets IP 25 mg Blood Pressure and Heart
22 Metoprolol Succinate Extended-Release Tablets IP 50 mg Blood Pressure and Heart
23 Metoprolol Succinate Extended-Release Tablets IP 100 mg Blood Pressure and Heart
24 Metoprolol Succinate Extended-Release Tablets IP 200 mg Blood Pressure and Heart
25 Pentoxifylline Extended-Release Tablets USP 400 mg Leg Pain due to poor blood flow
26 Pravastatin Tablets IP 10 mg Cholesterol
27 Pravastatin Tablets IP 20 mg Cholesterol
28 Pravastatin Tablets IP 40 mg Cholesterol
29 Procyclidine Hydrochloride tablets IP 2.5 mg Parkinson’s
30 Procyclidine Hydrochloride tablets IP 5 mg Parkinson’s
31 Propranolol Hydrochloride Extended-Release Capsules IP 80 mg Blood Pressure
32 Ritonavir tablets IP 100 mg Viral Infection (Part of Covid treatment)
33 Ritonavir tablets USP 100 mg Viral Infection (Part of Covid treatment)
34 Sitagliptin and Metformin Hydrochloride tablets 50 mg and 500 mg Diabetes
35 Sitagliptin and Metformin Hydrochloride tablets 50 mg and 850 mg Diabetes
36 Sitagliptin and Metformin Hydrochloride tablets 50 mg and 1000 mg Diabetes
37 Sitagliptin Tablets 25 mg Diabetes
38 Sitagliptin Tablets 50 mg Diabetes
39 Sitagliptin Tablets 100 mg Diabetes
40 Sitagliptin tablets USP 100 mg Diabetes
41 Telmisartan 20 mg + Amlodipine 2.5 mg + Hydrochlorothiazide 6.25 mg tablets Blood Pressure
42 Telmisartan 20 mg + Amlodipine 2.5 mg + Hydrochlorothiazide 12.5 mg tablets Blood Pressure
43 Telmisartan 40 mg + Amlodipine 5 mg + Hydrochlorothiazide 12.5 mg tablets Blood Pressure
44 Telmisartan 80 mg + Amlodipine 10 mg + Hydrochlorothiazide 25 mg tablets Blood Pressure
45 Telmisartan and Amlodipine tablets IP 40 mg/5 mg Blood Pressure
46 Telmisartan and Amlodipine tablets 40 mg/10 mg Blood Pressure
47 Telmisartan and Amlodipine tablets 80 mg/5 mg Blood Pressure
48 Telmisartan and Amlodipine tablets IP 80 mg/10 mg Blood Pressure
49 Telmisartan and Hydrochlorothiazide tablets 40 mg/ 12.5 mg Blood Pressure
50 Telmisartan and Hydrochlorothiazide tablets 80 mg/ 12.5mg Blood Pressure
51 Telmisartan and Hydrochlorothiazide tablets 80 mg/ 25 mg Blood Pressure
52 Telmisartan tablets 20 mg Blood Pressure
53 Telmisartan tablets IP 40 mg Blood Pressure
54 Telmisartan tablets IP 80 mg Blood Pressure
55 Tenofovir Disoproxil Fumarate, Lamivudine and Efavirenz tablets IP 300 mg, 300 mg, 600 mg Virus Infection
56 Tolvaptan Tablets 15 mg Kidney Disease
57 Tolvaptan Tablets 30 mg Kidney Disease
58 Ursodeoxycholic acid tablets 150 mg Liver Disease
59 Ursodeoxycholic acid tablets 300 mg Liver Disease

CRO List

S.No Product Name
(RLD used for Development)
Markets Available for Out-licensing Development Status Development Status for India Market
USA EU Canada China ROW Others
PRODUCTS READY FOR TECHNOLOGY TRANSFER
1 Esomeprazole Magnesium Delayed Release
Tablets 20 and 40 mg (Nexium® from EU)
Development completed and ready for exhibit batches Form-25 available for launching in India
2 Tenofovir Alafenamide Fumarate
Tablets 25 mg (VEMLIDY® from USA)
Development completed and ready for exhibit batches Approved in India less than 4-years ago and considered as new drug.
3 Ursodeoxycholic acid tablets 150, 250, 300,
and 500 mg (Urso Falk® from USA and /Urso Forte® from EU)
Development completed and ready for exhibit batches Form-25 for 300 mg tablets is approved and can be launched in India.
4 Ursodeoxycholic acid capsules 250, 300,
and 450 mg (Actigall® from USA/Ursofalk® from Europe)
Development completed and ready for exhibit batches It is not approved in India and considered as new drug.
4 Pentoxifylline ER Tablets USP 400 mg
(RLD is from AA Pharma Inc. Canada)
× Development completed and ready for exhibit batches Form-25 available for launching in India.
6 Guanfacine hydrochloride ER Tablets 1 mg, 2 mg, 3 mg
and 4 mg (INTUNIV® from USA/EU/Canada)
× × Development completed and ready for exhibit batches It is not approved in India and considered as new drug.
7 Doxylamine succinate 10 mg and Pyridoxine
HCl 10 mg DR tablets (Diclectin® from Canada)
× Development completed and ready for exhibit batches Approved in India. Indivar need to apply for Form-25 for marketing.
8 Fingolimod Capsules 0.5 mg
(Gilenya® from USA)
× Development completed and ready for exhibit batches Approved in India. Indivar need to apply for Form-25 for marketing.
9 Procyclidine Tablets BP 2.5, 5, 15, 30 mg (Kemadrin® from EU) Development completed and ready for exhibit batches Form-25 available for launching in India
10 Lansoprazole Orally Disintegrating
Tablets 15, 30 mg (TAKEPRON OD® from Japan and PREVACID® from EU)
Development completed and ready for exhibit batches It is not approved in India and considered as new drug.
11 Naftidrofuryl Capsules BP 100 mg
(PRAXILINE® from EU and Taiwan)
Development completed and ready for exhibit batches It is not approved in India and considered as new drug.
12 Linagliptin Tablets 5 mg
(TRADJENTA® from USA).
Development completed and ready for exhibit batches Form-25 available for launching in India.
13 Sacubitril/ Valsartan tablets 24 mg/ 26 mg, 49 mg/
51 mg, 97 mg/ 103 mg (ENTRESTO® from USA).
Development completed and ready for exhibit batches Form-25 available for launching in India.
14 Empagliflozin tablets 10 mg, 25 mg (JARDIANCE® from USA). Development completed and ready for exhibit batches Form-25 available for launching in India.
15 Rosuvastatin Calcium tablets 5 mg, 10 mg,
20 mg, 40 mg (CRESTOR® from USA)
Development in progress and tech-transfer can be done in Sep-2022. Form-25 available for launching in India.
16 Apixaban tablets 2.5 and 5 mg (ELIQUIS® from USA). Development completed and ready for exhibit batches Form-25 available for launching in India.
17 Sitagliptin tablets USP 25 mg, 50 mg, 100 mg (JANUVIA® from USA). Development completed and ready for exhibit batches Form-25 available for launching in India.
18 Sitagliptin and Metformin Hydrochloride tablets 50 mg/ 500 mg & 50 mg/ 1000 mg (JANUMET® from USA). Development completed and ready for exhibit batches Form-25 available for launching in India.
19 Tolvaptan Tablets 7.5, 15, 30, 45, 60, and 90 mg (Samsca®/Jinarc®/Jynarque® from EU/USA). Development completed and ready for exhibit batches Form-25 available for launching in India.
20 Linagliptin/Metformin HCl Tablets 2.5/500, 2.5/850, and 2.5/1000 mg (TRADJENTA DUO® from USA). Development completed and ready for exhibit batches. Form-25 available for launching in India.
21 Empagliflozin/Metformin HCl Tablets 5/500 mg, 12.5/500, 5/1000, and 12.5/1000 mg (SYNJARDY® from USA). Development completed and ready for exhibit batches Form-25 available for launching in India.
22 Telmisartan/Amlodipine tablets 40 mg/5 mg, 40/10, 80/5, 80/10 mg (TWYNTA® from EU). × Development completed and ready for exhibit batches Form-25 available for launching in India.
23 Telmisartan tablets 40 and 80 mg (MICARDIS HCT® from EU). Development completed and ready for exhibit batches. Form-25 available for launching in India.
24 Naltrexone HCl 8 mg and Bupropion Hydrochloride 90 mg ER Tablets (Contrave® Extended-Release Tablets from USA and EU) Development completed and ready tech-transfer and exhibit batches It is not approved in India and considered as new drug.
25 Propranolol HCl ER Capsules USP 60, 80, 120, and 160 mg (INDERAL® LA from USA) Development completed and ready tech-transfer and exhibit batches. Form-25 available for 80 mg strength for launching in India.
26 Metoprolol Succinate ER Tablets USP 25 mg, 50 mg, 100 mg and 200 mg (TOPROL XL® from USA) Development completed and ready for exhibit batches. Form-25 available for all strengths for launching in India.
PRODUCTS UNDER DEVELOPMENT
27 Telmisartan/Hydrochlorothiazide tablets 40/12.5, 80/12.5, and 80 mg/25 mg (MICARDIS HCT® from EU). Development is in progress Form-25 available for launching in India.
28 Paroxetine ER Tablets USP 12.5 mg, 25 mg and 37.5 mg (Paxil CR® from USA/Seroxat CR® from EU) Development is in progress. Approved in India. Indivar need to apply for Form-25 for marketing.
29 Tolterodine Tartrate SR Capsules 2 mg and 4 mg (Detrol LA® from USA) Development is in progress. It is not approved in India and considered as new drug.
30 Divalproex sodium ER Tablets 500 mg (DEPAKINE CHRONO® from EU) Development is in progress. Form-25 available for launching in India.
31 Quetiapine Extended-Release Tablets 50, 200, 300, and 400 mg (Seroquel XR® from USA) Development is in progress. Approved in India. Indivar need to apply for Form-25 for marketing.
32 Aspirin /Extended-Release Dipyridamole Capsules 25 mg/200 mg (AGGRENOX® from EU) Development is in progress. Approved in India. Indivar need to apply for Form-25 for marketing.
33 Olanzapine Oro-dispersible Tablets 2.5 mg, 5 mg, 7.5 mg, 10 mg (CATALANT® /ZYPREXA VOLETAB® from EU and China) Development is in progress. Approved in India. Indivar need to apply for Form-25 for marketing.
34 Efavirenz/lamivudine/Tenofovir Disoproxil Fumarate Tablets 600/300/300 mg (SYMFI® from USA). Development is in progress. Form-25 available for launching in india.
35 Edoxaban Tosylate tablets 15 mg, 30 mg, 60 mg (SAVAYSA®/ LIXIANA® from USA and EU). Development is in progress. It is not Approved in India and considered as new drug.
36 Telmisartan/Amlodipine/ Hydrochlorothiazide tablets 80 mg/ 10 mg/25mg (MICARDIS TRIO® from JAPAN). Development is in progress. Form-25 available for launching in india.
Telmisartan/Amlodipine/Hydrochlorothiazide tablets 40 mg/5 mg/12.5 mg (MICARDIS TRIO® from JAPAN).
Telmisartan/Amlodipine/ Hydrochlorothiazide tablets 20 mg/2.5 mg/12.5 mg (MICARDIS TRIO® from JAPAN).
Telmisartan/Amlodipine/ Hydrochlorothiazide tablets 20 mg/2.5 mg/6.5 mg (MICARDIS TRIO® from JAPAN).
37 Montelukast sodium chewable tablet 4 and 5 mg (SINGULAIR® from USA) Development is in progress. Form-25 available for launching in india.
38 Montelukast sodium tablet 10 mg (SINGULAIR® from USA) Development is in progress. Form-25 available for launching in india.
39 Amlodipine besylate and Atorvastatin calcium tablets 2.5/10, 2.5/20, 2.5/40, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, 10/80 mg (CADUET® from USA) Development is in progress. Form-25 available for launching in india.

Form-29 List

S.NO. NAME OF PRODUCT CDSCO Approval date/ status Valid till
1 Mesalamine DR Tablets USP 1.2 g 18/Dec/2020
2 Pentosan Polysulfate Sodium Capsules 100 mg 18/Dec/2020
3 Atorvastatin Calcium Tablets 10 mg, 20 mg, 40 mg and 80 mg 21/Feb/2021
4 Methazolamide Tablets USP 25 mg and 50 mg Unapproved 21/Feb/2021
5 Naltrexone HCl 8 mg and Bupropion Hydrochloride 90 mg ER Tablets Unapproved 21/Feb/2021
6 Propranolol HCl ER Capsules USP 80 mg 21/Feb/2021
7 Metoprolol Succinate ER Tablets USP 25 mg, 50 mg, 100 mg and 200 mg 8/Apr/2021
8 Albendazole Tablets 400 mg 18/Apr/2021
9 Propranolol HCl ER Capsules USP 60 mg, 120 mg and 160 mg Unapproved 18/Apr/2021
10 Aspirin SR Capsules 162.5 mg Unapproved 29/May/2021
11 Paroxetine ER Tablets USP 12.5 mg, 25 mg and 37.5 mg Unapproved Unapproved
12 Tolterodine Tartrate SR Capsules 2 mg and 4 mg Unapproved 29/May/2021
13 Tenofovir Alafenamide Tablets 25 mg Unapproved 21/May/2021
14 Ursodeoxycholic acid tablets 150 mg 12/Apr/2001 21/May/2021
15 Ursodeoxycholic acid tablets 300 mg 12/Apr/2001 21/May/2021
16 Pregabalin ER Tablets 82.5 mg, 165 mg and 330 mg Unapproved 29/May/2021
17 29/May/2021 10/Feb/2011 10/Jun/2021
18 Divalproex sodium ER Tablets 500 mg 1/Aug/2004 13/Jun/2021
19 Sodium valproate CR Tablets 750 mg 24/Jan/2008 13/Jun/2021
20 Sodium valproate CR Tablets 1000 mg 24/Jan/2008 13/Jun/2021
21 Enrofloxacin Tablets 15 mg, 50 mg and 150 mg Unapproved 6/Jul/2021
22 Pentoxifylline ER Tablets USP 400 mg 1/Mar/1990 18/Jul/2021
23 18/Jul/2021 26/Jun/2000 18/Jul/2021
24 Irbesartan Tablets 150 mg 26/Jun/2000 18/Jul/2021
25 Guanfacine hydrochloride ER Tablets 1 mg, 2 mg, 3 mg and 4 mg Unapproved 1/Aug/2021
26 Doxylamine succinate 10 mg and Pyridoxine HCl 10 mg DR tablets Unapproved 17/Aug/2021
27 Amlodipine & valsartan USP Tablets 5 mg/80 mg 21/Feb/2007 20/Aug/2021
28 Amlodipine & valsartan USP Tablets 5 mg/160 mg 21/Feb/2007 20/Aug/2021
29 Ivabradine Tablets 5 mg 3/Jul/2008 20/Aug/2021
30 Ivabradine Tablets 7.5 mg 3/Jul/2008 20/Aug/2021
31 Quetiapine Extended Release Tablets 50 mg 10/Apr/2007 10/Apr/2007
32 Quetiapine Extended Release Tablets 200 mg 1/Aug/2006 20/Aug/2021
33 Quetiapine Extended Release Tablets 300 mg 1/Aug/2006 20/Aug/2021
34 Quetiapine Extended Release Tablets 400 mg 5/Mar/2007 20/Aug/2021
35 Sevelamer Carbonate Tablets 800 mg 28/Apr/2008 20/Aug/2021
36 Sirolimus Tablets 1 mg 31/Dec/2002 20/Aug/2021
37 Fingolimod Capsules 0.5 mg Unapproved 20/Aug/2021
38 Aspirin /Extended Release Dipyridamole Capsules 25 mg/200 mg 27/Feb/2003 30/Aug/2021
39 Duloxetine Delayed Release Capsules USP 20 mg, 30 mg, 60 mg 2/Mar/2005 30/Aug/2021
40 Gefitinib Tablets 250 mg 18/Dec/2009
41 Cholestyramine for oral suspension 4 g/sachet 30/Mar/2006
42 Olanzapine Tablets 2.5 mg, 5 mg, 7.5 mg, 10 mg 27/Jan/2000 14/Oct/2021
43 Olanzapine Tablets 15 mg 18/Jan/2002 14/Oct/2021
44 14/Oct/2021 23/Jul/1999
45 Olanzapine ODTs 10 mg & 5 mg Unapproved 4/Dec/2021
46 Ursodeoxycholic acid Capsules 250 mg, 300 mg and 450 mg Ursodeoxycholic acid Tablets 250 mg and 500 mg Unapproved 4/Dec/2021
47 Sirolimus Tablets 0.5 mg Unapproved 4/Dec/2021
48 BAR502 (CAS#1612191-86-2) Tablets 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, 300 mg Unapproved 4/Jan/2022
49 Aspirin DR Tablets 25 mg, 75 mg, 81 mg, 100 mg Unapproved 4/Jan/2022
50 Indapamide Tablets BP 2.5 mg 1/Nov/1978 4/Jan/2022
51 Lisinopril Tablets BP 5, 10, 20 mg 1/Nov/1991 4/Jan/2022
52 Risedronate sodium tablets USP 35 mg 8/Oct/2007 4/Jan/2022
53 Risedronate sodium tablets USP 150 mg 16/Sep/2008 4/Jan/2022
54 Procyclidine Tablets BP 2.5 , 5mg IP2010 4/Jan/2022
55 Procyclidine Tablets BP 15, 30 mg Unapproved 4/Jan/2022
56 Candesartan Cilexetil Tablets USP 8, 16 mg 31/Aug/2000 4/Jan/2022
57 Pravastatin Tablets BP 10, 20, 40 mg 20/Dec/2000 4/Jan/2022
58 Esomeprazole mg DR Tablets 20, 40 mg 6/Apr/2011 4/Jan/2022
59 Atenolol Tablets 50, 100 mg 1/Sep/1985 4/Jan/2022
60 Imipramine Tablets 10, 25 mg IP2010 4/Jan/2022
61 Clomipramine Tablets 10, 25, 50 mg 1/Feb/1992 24/Jan/2022
62 Doxepin Capsules BP 10, 25, 50 mg 1/Sep/1972 24/Jan/2022
63 Ibuprofen SR Capsules 300, 400 mg 1/Mar/1990 24/Jan/2022
64 Omeprazole DR Capsules USP 20 mg 1/Apr/1991 24/Jan/2022
65 Clonazepam Tablets BP 0.25 mg 5/Jul/2001 24/Jan/2022
66 Clonazepam Tablets BP 0.5, 1, 2 mg 25/Jan/1995 24/Jan/2022
67 Azithromycin Tablets BP 250 mg 6/Mar/2013 24/Jan/2022
68 Paroxetine Tablets BP 10, 20, 30, 40 mg 4/Oct/2000 24/Jan/2022
69 Candesartan Cilexetil Tablets USP 4 mg 31/Aug/2000 24/Jan/2022
70 Citalopram Tablets 30 mg Unapproved 24/Jan/2022
71 Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP 2.5 mg / 0.025 mg 1/Jun/1969 24/Jan/2022
72 Indapamide Tablets BP 1.25 mg Unapproved 24/Jan/2022
73 Lamotrigine Tablets BP 25mg 14/May/1998 24/Jan/2022
74 Lamotrigine Tablets BP 100 mg 21/Jan/2000 24/Jan/2022
75 Lansoprazole Orally Disintegrating Tablets 15, 30 mg Unapproved 24/Jan/2022
76 Lisinopril Tablets BP 40 mg Unapproved 24/Jan/2022
77 Naftidrofuryl Capsules BP 100 mg Unapproved 24/Jan/2022
78 Omeprazole DR capsules USP 40 mg Unapproved 19/Feb/2022
79 Atenolol Tablets BP 25 mg Unapproved 19/Feb/2022
80 Imipramine Tablets BP 50 mg, 75 mg Unapproved 19/Feb/2022
81 Risedronate Sodium Tablets USP 5, 30, 75 mg Unapproved 19/Feb/2022
82 Acarbose Tablets USP 50 mg, 100 mg 6/Mar/1997 19/Feb/2022
83 Eltrombopag Olamine Tablets 25 mg, 50 mg 19/Oct/2010 19/Feb/2022
84 Bisoprolol Fumarate Tablets USP 2.5 mg 19/Jan/2001 22/May/2022
85 Bisoprolol Fumarate Tablets USP 5 mg and 10 mg 27/Feb/1992 22/May/2022
86 Mirtazapine Tablets USP 15 mg, 30 mg and 45 mg 13/Feb/2001 22/May/2022
87 Mycophenolate Mofetil Tablets USP 500 mg 7/Feb/1999 22/May/2022
88 Oxcarbazepine Tablets USP 150 mg, 300 mg and 600 mg 14/Jan/2002 22/May/2022
89 Imatinib Tablets IP 100 mg 26/Feb/2005 6/Jun/2022
90 Imatinib Tablets IP 400 mg 5/Apr/2010 6/Jun/2022
91 Erlotinib Tablets IP 25 mg, 100 mg, 150 mg 21/Jul/2005 6/Jun/2022
92 Gefitinib Tablets 250 mg 18/Dec/2009 6/Jun/2022
93 Canagliflozin Tablets 100 mg, 300 mg 17/Nov/2014 6/Jun/2022
94 Linagliptin Tablets 5 mg 23/Jan/2012 6/Jun/2022
95 Vildagliptin Tablets 50 mg, 100 mg 18/Jan/2008 6/Jun/2022
96 Tadalafil Tablets USP 2.5 mg, 5 mg 27/Feb/2013 23/Jul/2022
97 Tadalafil Tablets USP 10 mg and 20 mg 11/Sep/2003 23/Jul/2022
98 Sapropterin Dihydrochloride Tablets 100 mg Unapproved 23/Jul/2022
99 Desloratadine Syrup 0.5 mg/ml Unapproved 23/Jul/2022
100 Dapoxetine hydrochloride tablets 30 mg and 60 mg 15/Nov/2010 23/Jul/2022
101 Abiraterone acetate tablets 250 mg 16/Dec/2011 23/Jul/2022
102 Lopinavir/Ritonavir USP Tablets 100/25 mg 8/Sep/2008 23/Jul/2022
103 Lopinavir/Ritonavir USP Tablets 200/50 mg 8/Jun/2006 23/Jul/2022
104 Efavirenz/lamivudine/Tenofovir Disoproxil Fumarate Tablets 600/300/300 mg 23/Jul/2008 23/Jul/2022
105 Sacubitril/ Valsartan tablets 24 mg/ 26 mg, 49 mg/ 51 mg, 97 mg/ 103 mg Unapproved 25/Aug/2022
106 Empagliflozin tablets 10 mg, 25 mg 7/May/2015 25/Aug/2022
107 Rosuvastatin Calcium tablets 5 mg, 10 mg, 20 mg, 40 mg 8/Nov/2008 25/Aug/2022
108 Apixaban tablets 2.5 mg 3/Aug/2012 25/Aug/2022
109 Apixaban tablets 5 mg 16/May/2014 25/Aug/2022
110 Sitagliptin tablets USP 25 mg, 50 mg, 100 mg 31/Oct/2007 25/Aug/2022
111 Sitagliptin and Metformin Hydrochloride tablets 50 mg/ 500 mg & 50 mg/ 1000 mg 24/Apr/2008 25/Aug/2022
112 Dasatinib tablets 100 mg 10/Jul/2009 25/Aug/2022
113 Pazopanib tablets 200 mg 19/Oct/2010 25/Aug/2022
114 Sunitinib Malate Capsules 50 mg 11/Apr/2007 25/Aug/2022
115 Acetaminophen Extended Release tablets USP 650 mg 1996 25/Aug/2022
116 Obeticholic acid Tablets 5 mg & 10 mg Unapproved 10/Sep/2022
117 Fingolimod Capsules 0.25 mg Unapproved 10/Sep/2022
118 Capecitabine tablets USP 150 mg & 500 mg 12/Oct/2000 10/Sep/2022
119 12/Oct/2000 Unapproved 2/Oct/2022
120 Elagolix Tablets 150 mg Unapproved 2/Oct/2022
121 Elagolix Tablets 200 mg Unapproved 2/Oct/2022
122 Tolvaptan Tablets 15 mg 6/Sep/2012 2/Oct/2022
123 Tolvaptan Tablets 30 mg 6/Sep/2012 2/Oct/2022
124 Tenofovir Disoproxil Fumarate/ Emtricitabine/ Efavirenz tablets 300 mg/ 200 mg/ 600 mg 1/Aug/2006 2/Oct/2022
125 Abiraterone acetate tablets 500 mg Unapproved 14/Oct/2022
126 Edoxaban tosylate tablets 15 mg, 30 mg, 60 mg Unapproved 28/Oct/2022
127 Linagliptin/ Metformin HCl Tablets 2.5/500 mg, Linagliptin/ Metformin HCl Tablets 2.5/850 mg, Linagliptin/ Metformin HCl Tablets 2.5/1000 mg Unapproved 7/Nov/2022
128 Empagliflozin/ Metformin HCl Tablets 5/500 mg, Empagliflozin/ Metformin HCl Tablets 5/1000 mg, Empagliflozin/ Metformin HCl Tablets 12.5/500 mg Empagliflozin/ Metformin HCl Tablets 12.5/1000 mg Unapproved 7/Nov/2022
129 Sitagliptin and Metformin Hydrochloride tablets 50 mg/ 850 mg 2/Aug/2010 7/Nov/2022
130 Telmisartan/Amlodipine tablets 40 mg/5 mg 30/Aug/2006 22/Nov/2022
131 Telmisartan/Amlodipine tablets 80 mg/5 mg 30/Mar/2009 22/Nov/2022
132 Telmisartan/Amlodipine tablets 40 mg/10 mg 22/May/2008 22/Nov/2022
133 Telmisartan/Amlodipine tablets 80 mg/10 mg 31/May/2011 22/Nov/2022
134 Telmisartan/Hydrochlorothiazide tablets 80 mg/25 mg 14/May/2003 22/Nov/2022
135 Telmisartan/Hydrochlorothiazide tablets 40 mg/12.5 mg 29/Aug/2003 22/Nov/2022
136 Telmisartan/Hydrochlorothiazide tablets 80 mg/12.5 mg 29/Aug/2003 22/Nov/2022
137 Telmisartan tablets 40 mg 25/Nov/2002 11/Feb/2023
138 Telmisartan tablets 80 mg 25/Nov/2002 11/Feb/2023
139 Raltegravir tablets 400 mg 27/Jan/2010 11/Feb/2023
140 Atenolol tablets 50 mg , 100 mg Sep 1985 1/Mar/2023
141 Dolutegravir, Lamivudine and TDF tablets 50/300/300 mg Unapproved 1/Mar/2023
142 Efavirenz, Lamivudine and TDF tablets 400/300/300 mg Unapproved 1/Mar/2023
143 Carvedilol tablets USP 12.5, 25 mg 16/Oct/1998 23/Mar/2023
144 Carvedilol tablets USP 3.125, 6.25 mg 10/Mar/1999 23/Mar/2023
145 Edaravone Injection 1.5 mg/mL 27/Jul/2007 23/Mar/2023
146 Ciprofloxacin tablets 250 mg, 500 mg, 750 mg may 1989 7/Apr/2023
147 Hydroxychloroquine sulphate tablets 300 mg 9/Aug/2014 16/Apr/2023
148 Hydroxychloroquine sulphate tablets 400 mg 31/Jan/2008 16/Apr/2023
149 Hydroxychloroquine sulphate tablets 200 mg 26/Jun/2016 16/Apr/2023
150 Dexamethasone tablets 4 mg 2/Nov/2004 16/Apr/2023
151 Dexamethasone tablets 8 mg 2/Nov/2004 16/Apr/2023
152 Ketorolac Tromethamine tablets 10 mg 21/Apr/1992 16/Apr/2023
153 Fluvoxamine maleate tablets 50 mg 21/Feb/2000 16/Apr/2023
154 Fluvoxamine maleate tablets 100 mg 21/Feb/2000 16/Apr/2023
155 Everolimus tablets 2.5 mg 21/Mar/2013 17/May/2023
156 Everolimus tablets 5 mg 16/May/2009 17/May/2023
157 Everolimus tablets 10 mg 16/May/2009 17/May/2023
158 Nilotinib Capsules 150 mg 29/Sep/2010 17/May/2023
159 Nilotinib Capsules 200 mg 14/Jul/2010 17/May/2023
160 Ticagrelor tablets 90 mg 3/May/2012 26/May/2023
161 Tolvaptan tablets 7.5 mg Unapproved 26/May/2023
162 Tolvaptan tablets 45 mg Unapproved 18/Aug/2026
163 Tolvaptan tablets 60 mg Unapproved 26/May/2023
164 Tolvaptan tablets 90 mg Unapproved 26/May/2023
165 Dexamethasone tablets 2 mg Unapproved 26/May/2023
166 Dexamethasone tablets 6 mg Unapproved 26/May/2023
167 Metformin HCl tablets 500 mg , 850 mg IP 2010 26/May/2023
168 Ramipril capsules 1.25, 2.5, 5, 10 mg 2005 23/Jun/2023
169 Gabapentin capsules 300, 400 mg 3/Aug/1995 23/Jun/2023
170 Ibuprofen tablets 200 mg, 400mg, 600mg IP2010 4/Aug/2023
171 Telmisartan/Amlodipine/ Hydrochlorothaizide tablets 80 mg/ 10 mg/25mg 12/Oct/2010 23/Sep/2023
172 Telmisartan/Amlodipine/Hydrochlorothaizide tablets 40 mg/5 mg/12.5mg 12/Oct/2010 23/Sep/2023
173 Telmisartan/Amlodipine/ Hydrochlorothaizide tablets 20 mg/2.5 mg/12.5mg 12/Oct/2010 23/Sep/2023
174 Telmisartan/Amlodipine/ Hydrochlorothaizide tablets 20 mg/2.5 mg/6.25 mg 3/Jan/2013 23/Sep/2023
175 Rosuvastatin calcium tablets 5, 10, 20, 40 mg 8/Nov/2008 27/Oct/2023
176 Montelukast sodium chewable tablet 4, 5 mg 13/Feb/2002 27/Oct/2023
177 Montelukast sodium tablet 10 mg sep 2004 27/Oct/2023
178 Saxogliptin tablets 2.5 mg 26/Oct/2009 7/Dec/2023
179 Saxogliptin tablets 5 mg 26/Oct/2009 7/Dec/2023
180 Metformin (ER) and Saxagliptin tablets 1000 mg/ 2.5 mg 19/Sep/2011 7/Dec/2023
181 Metformin (ER) and Saxagliptin tablets 500 mg/ 5 mg 19/Sep/2011 7/Dec/2023
182 Rivaroxaban tablets 2.5 mg 13/Jul/2015 7/Dec/2023
183 Rivaroxaban tablets 10 mg 13/Feb/2010 7/Dec/2023
184 Rivaroxaban tablets 15 mg 2/Sep/2014 7/Dec/2023
185 Rivaroxaban tablets 20 mg 2/Sep/2014 7/Dec/2023
186 Dapagliflozin tablets 5 mg 25/Feb/2015 7/Dec/2023
187 Dapagliflozin tablets 10 mg 25/Feb/2015 7/Dec/2023
188 Acetaminophen and Ibuprofen tablets 250/125 mg Unapproved 4/Jan/2024
189 Orlistat capsules 60 mg 1/Jun/2009 5/Feb/2024
190 Orlistat capsules 120 mg 22/Aug/2007 5/Feb/2024
191 Sildenafil citrate orally disintegrating tablets 25 mg 8/Jan/2001 5/Feb/2024
192 Sildenafil citrate orally disintegrating tablets 50 mg 8/Jan/2001 5/Feb/2024
193 Nintedanib soft gelatin capsules 100 mg 11/Mar/2016 5/Feb/2024
194 Nintedanib soft gelatin capsules 150 mg 11/Mar/2016 5/Feb/2024
195 Procyclidine Hydrochloride tablets 10 mg Unapproved 18/Feb/2024
196 Ramipril capsules 15 mg Unapproved 18/Feb/2024
197 Vildagliptin tablets 50 mg 18/Jan/2008 18/Feb/2024
198 Vildagliptin tablets 100 mg 18/Jan/2008 18/Feb/2024
199 Vildagliptin tablets 100 mg 21/Jul/2008 18/Feb/2024
200 Vildagliptin and Metformin Hydrochloride tablets 50 mg/ 850 mg 21/Jul/2008 18/Feb/2024
201 Vildagliptin and Metformin Hydrochloride tablets 50 mg/ 1000 mg 21/Jul/2008 18/Feb/2024
202 Atorvastatin Calcium Tablets 10 mg, 20 mg, 40 mg 17/Sep/1999 8/Mar/2024
203 Atorvastatin Calcium Tablets 80 mg 25/Feb/2008 8/Mar/2024
204 Amlodipine besylate and Atorvastatin calcium tablets 2.5/10 mg 10/Feb/2004 8/Mar/2024
205 Amlodipine besylate and Atorvastatin calcium tablets 5/10 mg 11/Feb/2004 8/Mar/2024
206 Carbamazepine tablets 200 mg IP2010 8/Mar/2024
207 Dicyclomine tablets 20 mg IP2010 8/Mar/2024
208 Amlodipine besylate and Atorvastatin calcium tablets 2.5/20 mg Unapproved 25/Apr/2024
209 Amlodipine besylate and Atorvastatin calcium tablets 2.5/40 mg Unapproved 25/Apr/2024
210 Amlodipine besylate and Atorvastatin calcium tablets 5/20 mg Unapproved 25/Apr/2024
211 Amlodipine besylate and Atorvastatin calcium tablets 5/40 mg Unapproved 25/Apr/2024
212 Amlodipine besylate and Atorvastatin calcium tablets 5/80 mg Unapproved 25/Apr/2024
213 Amlodipine besylate and Atorvastatin calcium tablets 10/10 mg Unapproved 25/Apr/2024
214 Amlodipine besylate and Atorvastatin calcium tablets 10/20 mg Unapproved 25/Apr/2024
215 Amlodipine besylate and Atorvastatin calcium tablets 10/40 mg Unapproved 25/Apr/2024
216 Amlodipine besylate and Atorvastatin calcium tablets 10/80 mg Unapproved 25/Apr/2024
217 Pazopanib tablets 400 mg 19/Oct/2010 25/Apr/2024
218 Itopride Hydrochloride tablets 50 mg 9/May/2002 25/Apr/2024
219 Enzalutamide tablets 40 mg Unapproved 25/Apr/2024
220 Enzalutamide tablets 80 mg Unapproved 25/Apr/2024
221 Bosutinib tablets 100 mg Unapproved 25/Apr/2024
222 Palbociclib tablets 125 mg Unapproved 12/May/2024
223 Tofacitinib ER tablets 22 mg Unapproved 23/May/2024
224 Ursodeoxycholic acid tablets 100 mg Unapproved 23/May/2024
225 Ursodeoxycholic acid tablets 200 mg Unapproved 23/May/2024
226 Amlodipine tablet 5 mg 15/Jun/2024
227 Amlodipine tablet 10 mg 15/Jun/2024
228 Azithromycin tablets 250 mg 15/Jun/2024
229 Azithromycin tablets 500 mg 15/Jun/2024
230 Azithromycin tablets 500 mg 15/Jun/2024
231 Fexofenadine Hydrochloride tablets 180 mg 15/Jun/2024
232 Salbutamol tablets 4 mg 15/Jun/2024
233 Famotidine for oral suspension 40mg/ 5 mL 15/Jun/2024
234 Ursodeoxycholic acid tablets 300 mg 15/Jun/2024
235 Aceclofenac and Paracetamol tablets 100 mg/500 mg 15/Jun/2024
236 Fexofenadine Hydrochloride and Montelukast tablets 120mg/ 10 mg 15/Jun/2024
237 Glimepiride tablets 1 mg 15/Jun/2024
238 Glimepiride tablets 2 mg 15/Jun/2024
239 Glimepiride tablets 3 mg 15/Jun/2024
240 Glimepiride tablets 4 mg 15/Jun/2024
241 Glimepiride and Metformin Hydrochloride Sustained release tablet 1 mg/500 mg 15/Jun/2024
242 Glimepiride and Metformin Hydrochloride Sustained release tablet 2 mg/ 500 mg 15/Jun/2024
243 Glimepiride and Metformin Hydrochloride Sustained release tablet 1 mg/1000 mg 15/Jun/2024
244 Glimepiride and Metformin Hydrochloride Sustained release tablet 2 mg/ 1000 mg 15/Jun/2024
245 Pantoprazole Gastro Resistant tablets 40 mg 15/Jun/2024
246 Rebamipide tablets 100 mg 30/Jun/2024
247 Felodipine Extended Release tablets 5 mg 30/Jun/2024
248 Felodipine Extended Release tablets 10 mg 30/Jun/2024
249 Pantoprazole gastro resistant 40 mg and Domperidone prolonged release 30 mg capsules IP 30/Jun/2024
250 Pantoprazole gastro resistant 40 mg and Domperidone prolonged release 10 mg capsules 30/Jun/2024
251 Pantoprazole gastro resistant 20 mg and Domperidone prolonged release 30 mg capsules 30/Jun/2024
252 Omeprazole gastro resistant 20 mg and Domperidone sustained release 30 mg capsules 30/Jun/2024
253 Esomeprazole 20 mg and Domperidone sustained release 30 mg capsules 30/Jun/2024
254 Esomeprazole 40 mg and Domperidone sustained release 30 mg capsules 30/Jun/2024
255 Itraconazole capsules 100 mg 30/Jun/2024
256 Aceclofenac 100 mg and Paracetamol 325 mg tablets 30/Jun/2024
257 Amlodipine besylate tablet 2.5 mg 19/May/1993 29/Jul/2024
258 Levocetrizine dihydrochloride tablets 5 mg IP2010 29/Jul/2024
259 Montelukast sodium and levocetrizine dihydrochloride tabelts 10mg / 5 mg 31/Jan/2008 29/Jul/2024
260 Desloratidine tablets 5 mg 14/Jan/2002 29/Jul/2024
261 Montelukast sodium and Desloratidine tablets 10 mg and 5 mg 10/Nov/2008 29/Jul/2024
262 Ibuprofen and Glucosamine sulfate tablets 200mg + 500 mg 3/Nov/2009 29/Jul/2024
263 ibuprofen and chlorozoxazone tablets 400 mg + 500 mg 7/Apr/2010 29/Jul/2024
264 Ibuprofen and Paracetamol tablets 400 mg and 325 mg Oct 1984 29/Jul/2024
265 Aceclofenac tablets 100 mg 5/Apr/2007 29/Jul/2024
266 Gliclazide tablets 80 mg nov 1998 29/Jul/2024
267 Pioglitazone tablets 15 mg 17/Oct/2000 1/Aug/2024
268 Pioglitazone tablets 30 mg 17/Oct/2000 1/Aug/2024
269 Pioglitazone tablets 45 mg 17/Oct/2000 1/Aug/2024
270 Metformin HCl Sustained release tablets 500 mg 9/Nov/2001 1/Aug/2024
271 Metformin HCl Sustained release tablets 1000 mg 2002 1/Aug/2024
272 Glibenclamide/ Metfromin HCl SR tablets 2.5mg / 500 mg 20/Aug/2004 1/Aug/2024
273 Glibenclamide/ Metfromin HCl SR tablets 5mg / 500 mg 20/Aug/2004 1/Aug/2024
274 Glibenclamide/ Metfromin HCl SR tablets 5mg / 850 mg 15/Feb/2007 1/Aug/2024
275 Pioglitazone/ Metformin HCl SR tablets 15mg/ 1000 mg 23/Jan/2007 1/Aug/2024
276 Pioglitazone/ Metformin HCl SR tablets 30mg/ 1000 mg 23/Jan/2007 1/Aug/2024
277 Atorvastatin calcium and Metoprolol succinate Extended release tablets 10mg/ 25 mg 28/Jan/2008 1/Aug/2024
278 Atorvastatin calcium and Metoprolol succinate Extended release tablets 10mg/ 50 mg 28/Jan/2008 1/Aug/2024
279 Atorvastatin calcium and Ezetimibe tablets 10mg/ 10 mg 13/Aug/2004 1/Aug/2024
280 Atorvastatin calcium and Ezetimibe tablets 20mg/ 10 mg 13/Aug/2004 1/Aug/2024
281 Atorvastatin calcium and Ezetimibe tablets 40mg/ 10 mg 30/Jul/2007 1/Aug/2024
282 Atorvastatin calcium and Aspirin capsules 10mg/ 75 mg 18/Jan/2008 1/Aug/2024
283 Atorvastatin calcium and Aspirin capsules 10mg/ 150 mg 18/Jan/2008 1/Aug/2024
284 Mesalamine Delayed Release Tablets USP 1.2 g 27/Aug/2024
285 Tenofovir Alafenamide Tablets 25 mg Unapproved 27/Aug/2024
286 Paracetamol Fast Release Tablets 500 mg 27/Aug/2024
287 Rosuvastatin 5 mg and Clopidogrel 75 mg capsules 26/Aug/2024
288 Rosuvastatin 10 mg and Clopidogrel 75 mg capsules 26/Aug/2024
289 Rosuvastatin 20 mg and Clopidogrel 75 mg capsules 26/Aug/2024
290 Atorvastatin Calcium 10mg and Clopidogrel 75mg capsules 26/Aug/2024
291 Atorvastatin Calcium 20mg and Clopidogrel 75mg capsules 26/Aug/2024
292 Rupatadine tablets 10 mg 17/Sep/2024
293 Rupatadine 10 mg and Montelukast 10 mg tablets 17/Sep/2024
294 Levocetrizine Dihydrochloride Dispersible tablets 5 mg 17/Sep/2024
295 Levocetrizine Dihydrochloride Dispersible tablets 10 mg 17/Sep/2024
296 Rosuvastatin 5 mg and Aspirin tablets 75 mg 17/Sep/2024
297 Rosuvastatin 10 mg and Aspirin tablets 75 mg 17/Sep/2024
298 Rosuvastatin 10 mg and Aspirin tablets 150 mg 17/Sep/2024
299 Rosuvastatin 5 mg and Clopidogrel 75 mg film coated tablets 17/Sep/2024
300 Rosuvastatin 10 mg and Clopidogrel 75 mg film coated tablets 17/Sep/2024
301 Atorvastatin 5mg and Fenofibrate 145mg tablet 17/Sep/2024
302 Atorvastatin 5mg and Fenofibrate 160mg 17/Sep/2024
303 Atorvastatin 10mg and Fenofibrate 80mg tablet 17/Sep/2024
304 Atorvastatin 10mg and Fenofibrate 145mg tablet 17/Sep/2024
305 Atorvastatin 10 mg and Fenofibrate 160mg tablets 17/Sep/2024
306 Atorvastatin 10mg and Fenofibrate 200mg tablet 17/Sep/2024
307 Atorvastatin 20mg and Fenofibrate 160mg tablets 17/Sep/2024
308 Oxazepam tablets 10 mg 17/Sep/2024
309 Oxazepam tablets 15 mg 17/Sep/2024
310 Oxazepam tablets 30 mg 17/Sep/2024
311 Rosuvastatin 5 mg and Fenofibrate 67mg Tablets 17/Sep/2024
312 Rosuvastatin 5mg and Fenofibrate 145mg Tablet 17/Sep/2024
313 Rosuvastatin 5mg and Fenofibrate 160mg tablets 17/Sep/2024
314 Rosuvastatin 10mg and Fenofibrate 67.5 mg Tablet 17/Sep/2024
315 Rosuvastatin 10 mg and Fenofibrate 145 mg Tablets 17/Sep/2024
316 Rosuvastatin 10mg and Fenofibrate 160mg tablets 17/Sep/2024
317 Rosuvastatin 20mg and Fenofibrate 67.5mg Tablets 17/Sep/2024
318 Rosuvastatin 20mg and Fenofibrate 145mg Tablets 17/Sep/2024
319 Rosuvastatin 20 mg and Fenofibrate 160 mg tablets 17/Sep/2024
320 Guanfacine hydrochloride ER Tablets 1 mg, 2 mg, 3 mg and 4 mg 6/Dec/2024
321 Solifenacin Succinate 6mg and Tamsulosin Hydrochloride 0.4mg Modified Release Tablets 6/Dec/2024
322 Sirolimus tablets 2 mg 01.12.2003 6/Dec/2024
323 Sirolimus tablets 1 mg 6/Dec/2024
324 Sirolimus tablets 0.5 mg 6/Dec/2024
325 MSP008-22 tablets 100 mg 3/Jan/2025
326 MSP008-22 tablets 200 mg 3/Jan/2025
327 MSP008-22 tablets 400 mg 3/Jan/2025
328 MSP008-22 tablets 500 mg 3/Jan/2025
329 MSP008-22 tablets 600 mg 3/Jan/2025
330 MSP008-22 tablets 750 mg 3/Jan/2025
331 Ritonavir capsules 100 mg 3/Jan/2025
332 Ritonavir tablets 100 mg 3/Jan/2025
333 Bosutinib film coated tablets 400 mg Unapproved Unapproved
334 Brivaracetam tablets 100 mg Approved 14/Aug/2025
335 Pentoxifylline ER Tablets USP 400 mg 19/Sep/2025
336
337 Sitagliptin Tablets USP 100 mg Approved 18/Nov/2025
338 Sitagliptin Tablets USP 25 mg Approved 18/Nov/2025
339 Sitagliptin Tablets USP 50 mg Approved 18/Nov/2025
340 Dapagliflozin and Metformin HCl Extended release tablets 10/ 1000 mg Unapproved 6/Dec/2025
341 Ursodeoxycholic acid Capsules USP 250 mg Unapproved 15/Feb/2026
342 Ibuprofen tablets BP 400 mg Approved 8/Mar/2026
343 Naproxen and Esomeprazole Magnesium Delayed Release Tablets 500/20mg Unapproved 8/Mar/2026
344 Paracetamol tablets BP 500 mg Approved 8/Mar/2026

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