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. ![]() |
CONTACT :| USA +1 561
865 6147
-| info @ Locum
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