TITLE 21
READY-TO-GO CMC SERIES

GENERIC DRUG DEVELOPMENT CMC KNOW-HOW LIST

Contents of a Ready-To-Go Dossier

RTG DRUG PRODUCT FORM Strength USD EURO
60 Gemfibrosil US/EU
Tablets
450 mg/600 mg
C
C
61 Glibenclamide US/EU
Tablets
5 mg
A
A
62 Glipizide Extended Release
Tablets ER
10 mg
C
C
63 Ibuprofen US / EU
Tablets
200/400/600mg
C
C
64 Imodium
Caplet
2mg
A
A
65 Isosorbide Mononitrate US/EU
Tablets
20 / 40 mg
B
B
66 Ketorolac Tromethamine US/EU
Tablets
10 mg
B
B
67 Levodopa/ Benserazide HCl US/EU
Tablets
200 / 50 mg
C
C
68 Labetalol HCL (100; 200; 300mg)
Tablets
100/200/300mg
C
C
70 Lisinopril US / EU
Tablets
2.5/5.0/10mg
D
D
71 Lisinopril US / EU
Tablets
10/20/40mg
D
D
72 Loperamide US / EU
Tablets
2mg
A
A
73 Lovistatin = Ayerst
Tablets
10/20/40mg
B
B
74 Mesalamine (Enteric Coated)
EC Tablets
400mg
B
B
75 Metformin HCl = GLUCOPHAGE® BMS
Tablets
500/850mg
C
C
76 Miconazole / Hydrocortisone
Cream
2% + 1%
C
C
77 Miconazole Nitrate
Gel or Cream
2%
B
B
78 Nabumatone US & EU
Tablets
500/750mg
B
B
79 Naproxen DR (Enteric Coated) US/EU
Tablets DR
250/375/500mg
C
C
[List 1] [List 2] [List 3] [List 4] [List 5]


Title 21 - Ready-To-Go Price Range - US Dollars $
A - $2999 - $3499 USD B - USD $2999 - $3999 C - USD $3999 - $4999
D - USD $4500 - $4999 E - USD $5000 - $6999 SP - USD $7000 - $7990

DOWNLOAD The Ready-To-Go™ List - (PDF Format)
IAGIM's Ready-To-Go™ CMC Drug Development Know-How Series may be downloaded as a current reference source.

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