Home API Drug Master Files
List of Drug Master Files submitted to US FDA :
No.
API Commercialized Category US DMF No.
1.
Metformin HCL Anti diabetic 18150/14055
2.
Metformin HCL DC Grade 90% Anti diabetic 18887
3.
Metformin HCL DC Grade 95% Anti diabetic 18888
4.
Metformin HCL DC Grade 70% Anti diabetic 20573
5.
Tramadol Hydrochloride Analgesic 17970
6.
Sertraline Hydrochloride (Form I and Form II) Anti depressant 19931/19035
7.
Diphenhydramine Hydrochloride Anti histaminic 20572
8.
Diphenhydramine Citrate Anti histaminic 19986
9.
Promethazine Hydrochloride Anti histaminic 18173
10.
Mefenamic Acid Anti inflammatory 16491
11.
Glucosamine HCL Anti arthritic 19143
12.
Glucosamine Sulfate Potassium Chloride Anti arthritic 19639
13.
Glucosamine Sulfate Sodium Chloride Anti arthritic 19641
14.
Methoxsalen Pigmentation agent 20038
15.
Paroxetine Hydrochloride Hemihydrate Anti depressant 20248
16.
Carvedilol Phosphate Monohydrate Antihypertensive 23467
Products Under Upscale
Products Category
Carvedilol Antihypertensive
Clopidogrel Bisulphate Antithrombotic
Levetiracetam Antiepileptic
Gabapentin Antiepileptic, neuropathic pain
Risperidone Antisychotic
Pantoprazole Sodium Sesquihydrate Antiulcerative
Products Under Upscale
Products Category
Valsartan Antihypertensive
Telmisartan Antithrombotic
Losartan Potassium Antiepileptic
Valacyclovir Antiviral
Lercanidipin Antihypertensive
Duloxetine Antidepressant