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TITLE 19 - HANDBOOK SERIES TITLE 21 - CMC Ready-To-Go Series


TITLE 21
READY-TO-GO CMC SERIES

KEY GENERIC DRUG DEVELOPMENT CMC KNOW-HOW

Contents of a Ready-To-Go Dossier

RTG DRUG PRODUCT FORM Strength USD eFile (Ab)
20B Carvedilol  3 / 6 / 12 / 25mg US/EU 
Tablets
3.125/25mg
D
1/3
21 Carbidopa/Levodopa  US/EU 
Tablets
25/250mg
B
1/3
22 Carbidopa/Levodopa   US/EU
ER Tablets
50/200mg
C
1/3
23 Cefaclor Oral Suspension US/EU
Suspension
125 /187 mg/5mL
B
1/3
24 Cefaclor Oral Suspension US/EU
Suspension
250/375 mg/5mL
B
1/3
25 Cefaclor Oral Suspension US/EU
Suspension
250 mg/5mL
B
1/3
26 Cefaclor US/EU 
Capsules
250/500mg
B
1/3
27 Cefalexin (= Keflex) US/EU
Capsules
250/500mg
B
1/3
28 Cefuroxime Sodium US/EU
Vials
750-1500mg
C
1/3
29 Clonazepam Tablets US/EU
Tablets USP
0.5/1.0/ 2.0mg
B
1/3
30 Clomiphene Citrate
Tablets USP
50mg
A
A
31 Clomipramine HCl
Capsules
25 / 50 / 75 mg
B
1/3
32 Cloramphenicol / Prednisolone
Cream
3.0 / 0.5%
A
1/3
33 Cimetidine Chew Tablets
ChewTabs
100 mg
B
1/3
34 Diclofenac Potassium US/EU 
Tablets
25 / 50 mg
B
1/3
35 Diclofenac K + Misoprostol 200mcg US/EU 
Tablets
25 / 50 mg
C
1/3
36 Diclofenac Sodium + Misoprostol 200mcg US/EU 
Tablets
50 / 75 mg
C
1/3
37 Diclofenac Sodium US/EU 
Tablets
50 / 75 mg
B
1/3
38 Diclofenac Sodium US/EU 
Tablets SR
100 mg
D
1/3
39 Diclofenac Sodium US/EU
Clear Gel
10 mg/g
B
1/3
40 Dorzolamide HCL Ophthalmic
Solution
2% 
B
1/3
41 Etodolac = Wyeth Lodine
Capsules IR
200/300mg
B
1/3
42 Etodolac = Wyeth Lodine™
Tablets IR
400/500 mg
B
1/3
43 Etodolac = WyethAyerst Lodine XL™ US & EU
Tablets ER
400/500/600mg
C
1/3
44 Enalapril Maleate
Tablets
20 mg
B
1/3
45 Etidronate Disodium
Tablets
 
B
1/3
46 Famotidine = Merck's Pepsid
Tablets
10 / 20 / 40 mg
B
1/3
47 Famotidine = Merck's Pepsid AC
ChewTabs
10mg
B
1/3
48 FelodipineUS & EU
Tablets
5/10mg
B
1/3
50 Felodipine Extended Release
US & EU
ER Tablets
2.5 / 5 / 10 mg
C
1/3
51 Fluocinolone acetate
Cream
0.25%
B
1/3
52 Fluoxamine maleate = Solway's Luvox™ US & EU
Tablets 
20,50 100mg
B
1/3
53 Flunisolide Hemihydrate solution
Nasal solution
1mg/5mL
B
1/3
54 Flunitazapam US & EU
Tablets
2 mg
B
1/3
55 Fluoxetine US & EU
Capsules
10 / 20 mg
B
1/3
56 Fluoxetine US & EU
Tablets DC
10 / 20 mg
B
1/3
57 Fusemide US & EU
Capsules
40 mg
B
1/3
58 Gabapentin (=Neurontin-Park Davis) US & EU
Capsules
100/200 mg
A
1/3
59A Gabapentin (=Neurontin-Park Davis) US & EU
Capsules
300/400 mg
B
1/3
[List 1] [List 2] [List 3] [List 4] [List 5]

NOTE : EULA and IAGIM Rules / Regulations apply to Ready-To-Go CMC Series

Title 21 Ready-To-Go Price Range - US Dollars $ value (Extended Benefit Plans)
A - $2999 - $3499 USD B - USD $2999 - $3999 C - USD $3999 - $4999
D - USD $4500 - $4999 E - USD $5000 - $6999 SP - USD $7000 - $7990
Abbreviated Title 21 e-files reduce file cost by 66% of full content print files


Title 21 Abbreviated e-Files (PDF Format - Low cost electronic preview)
REVIEW
Title 21 abbreviated e-file (pay about a 1/3) of the above price structures are available for developers who would prefer to review the outline summary commercial formula and outline abbreviated process before purchasing the complete print volume. The print cost then reduced by the abbreviated efile amount paid.

SINGLE DOSE & MULTIDOSE DOSE COSTING
* Single dose (lowest $ amount) and multidose (highest $ amount) For IAGIM extended benefit plans, the exact amounts are calculated per item and costs increase proportionally as the number of strengths increase. (CMC files are presented per product containing all the unit strengths and not per strength or part thereof)

IAGIM's Ready-To-Go CMC Drug Development Know-How Series may be downloaded as a current reference source.

Review period : 2016/17




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