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Sr No Therapeutic Category Product Spec EDMF/CTD Written Confirmation IDL PMDA USDMF
1 ANTIMALARIAL Quinine Anhydrous (Base) IN HOUSE
2 Amodiaquine Base USP ✔
3 Amodiaquine Hydrochloride USP ✔
4 Chloroquine Phosphate IP/EP/BP/USP ✔ ✔
5 Piperaquine Phosphate IH TM ✔ ✔
6 Dihydroartemisinin (DHAM) INT PH ✔
7 Lumefantrine INT PH ✔ ✔
8 Artemether INT PH ✔ ✔ ✔
9 Alpha Beta Arteether (á – ß Arteether) IP ✔
10 Artesunate INT PH ✔ ✔
11 Quinine Dihydrochloride BP/IP ✔ ✔
12 Quinine Hydrochloride EP/BP ✔ ✔
13 Quinine Bi Sulphate BP ✔ ✔
14 Quinine Sulphate IP/EP/BP/USP ✔ ✔
15 Other Alkoloids Cinchonidine IH TM
16 Cinchonine IH TM
17 AUTOIMMUNE Hydroxychloroquine Sulphate IP/BP/EP/USP ✔ ✔
18 ANTIVIRAL Acyclovir (Aciclovir) IP/BP/EP/USP ✔ ✔
19 ANTI ARRHYTHMIAS Quinidine Base IH
20 Quinidine Sulphate EP/BP/USP ✔
21 NSAID (Non Sterodal Anti inflamatory drug) Mefenamic Acid IP/EP/BP/USP ✔ ✔
22 Nimesulide EP/BP ✔ ✔ ✔
23 ANTIBACTERIAL Moxifloxacin Anhydrous (Base IH House
24 Moxifloxacin Hydrochloride EP/BP/IP/USP ✔ ✔
25 Levofloxacin Hemihydrate IP/USP ✔ ✔
26 Ofloxacin IP/EP/BP/USP ✔ ✔
27 ANTISPASMODIC Hyoscyamine Sulfate EP/BP/USP ✔ ✔
28 Hyoscyamine Hydro Bromide EP/BP
29 Hyoscine Methyl Bromide (Methscopolamine Bromide) EP/BP/USP ✔ ✔
30 Hyoscine Hydro Bromide USP/EP/BP ✔ ✔ ✔
31 Hyoscine (Scopolamine) Butyl Bromide IP/EP/BP ✔ ✔ ✔ ✔
32 MUSCLE RELAXANT Thiocolchicoside IP/BP/EP ✔ ✔
33 ANTI GOUT Colchicine IP/EP/BP/USP ✔ ✔ ✔ ✔
34 CARDIAC DRUG Digoxin EP/BP/IP/USP ✔ ✔ ✔ ✔
35 ANTI-INFLAMMATORY ANALGESICS Diacerein IP/EP/BP ✔
36 ERECTILE DYSFUNCTION & MYDRIATIC AGENT Yohimbine Extract 8% IH
37 Yohimbine Extract 2% IH
38 Yohimbine Hydrochloride EP/BP/USP ✔ ✔ ✔
39 VASODILATOR Vincamine Pallets IH
40 Vincamine EP/IH
41 Vinpocetine EP/BP/USP ✔ ✔
42 LAXATIVE Senna Extract
43 Calcium Sennoside 9 0%
44 Calcium Sennoside 6 0% (UV)
45 Calcium Sennoside 45% (HPLC)
46 Calcium Sennoside 15%-25 & 40% JP/IH ✔ ✔
47 ANTIHYPERTENSION Rauwolfia Extract IH
48 Reserpine IP/EP/BP/USP ✔ ✔ ✔
49 VITAMINS Vitamin B2 5 Phosphate EP/BP ✔
50 Folic Acid IP/EP/BP/USP ✔
51 Hydroxocobalamin Acetate EP/BP ✔
52 Mecobalamin (Methylcobalamin) JP/IP/USP ✔ ✔ ✔ ✔
53 ANTIHISTAMINES / DECONGESTANTS Phenylephrine Hydrochloride IP/EP/BP/USP ✔ ✔
54 Phenylpropanolamine Hydrochloride EP/BP/USP ✔
55 Cetirizine Dihydrochloride (Cetirizine Hydrochloride) IP/EP/BP/USP ✔ ✔
56 Levocetirizine Dihydrochloride (Levocetirizine Hydrochloride) IP/USP ✔ ✔
57 ANTI ANGINAL AGENT Nicorandil JP/IP/EP/BP ✔ ✔ ✔ ✔
58 ANTIFUNGAL Bifonazole EP/BP ✔ ✔
59 ANTICHOLINERGICS Cimetropium Bromide IH House
60 Homatropine Methyl Bromide EP/BP/USP ✔
61 ANTINEUROPATHIC Pregabalin IP/EP/BP ✔
62 ANTI-CANCER INTERMEDIATES Camptothecin IH
63 10-De Acetyl Baccatin II (10-DAB) 9 8% IH
64 OTHER INTERMIDIATES Scopine Hydrochloride
65 Methyl 2, 2 – Dithienylglycolate
66 4-Chlorobenzhydril Piperazine (CBHP) IH
67 Cetirizine Base IH
68 Hydroxynovaldiamine (HNDA)
69 4,7 DCQ (Di Chloroquinoline) IH
70 PRODUCT UNDER VALIDATION Losartan Potassium
71 PRODUCTS UNDER DEVELOPMENT Ketamine Hydrochloride (Anesthetic) EP/BP
72 7-Ethyl-10 – Hydroxy Camptothecin
73 COQ-10 (Ubidecarenone)
74 Ipratropium Bromide
75 Tiotropium Bromide Monohydrate
76 Hyoscine (Scopolamine) Base
77 Gancyclovir (Ganciclovir)
78 Valacyclovir (Valaciclovir)
79 Primaquine Phosphate
80 Pyrimethamine
81 Sulfadoxine
82 Alpha Lipoic Acid
83 Sodium Hyaluronate (Hyaluronic Acid)

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