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


TITLE 21
READY-
TO-GO CMC SERIES

GENERIC DRUG DEVELOPMENT - CMC KNOWHOW

Contents of a Ready-To-Go Dossier

RTG DRUG PRODUCT FORM Strength (mg) USD EURO
1 Alendronate Sodium US & EU Tablets 5 - 10 mg
B
B
2 Alendronate Sodium Tablets 40 / 80mg
B
B
3 Aluminium Magnesium Suspension -
A
A
4 Amitriphyline HCl Tablets 10 mg
A
A
5 Azithromycin US & EU Suspension 200 mg
B
B
6 Azithromycin Capsules 250
B
B
7 Azithromycin Tablets 500 & 600
B
B
8 Atenolol + Chlorthalidone (Soon) Tablets 100-50/25
B
B
9 Atenolol US / EU Tablets 50 /100 mg
B
B
10 Amoxicillin Capsules 250 & 500
B
B
11 Bisoprolol Fumerate / HCTZ=ZIAC Tablets 5, 10, 25 + 6.25 mg
C
C
12 Bromhexine Hydrochloride Tablets + Syrup 8mg
B
B
13 Bromocriptine Mesylate Tablets 2.5mg
B
B
14 Bupropion US & EU Tablets 75/100 mg
B
B
15 Buspirone HCl US & EU Tablets 5 mg /10 mg
B
B
16 Carbamazepine = Geigy US & EU Tablets 200mg
B
B
17 Carbamazepine = Geigy ChewTabs ChewTabs 100 mg
C
C
18 Carbamazepine (Extended Release) Geigy TEGRATOL 400 mg XR™ ER Coated Tab 400 mg
C
C
19 Carbidopa/Levodopa US & EU Tablets 10/100 mg
B
B
20 Carbidopa/Levodopa US & EU Tablets 25/100 mg
B
B
[List 1] [List 2] [List 3] [List 4] [List 5]

NOTE : EULA and IAGIM Rules / Regulations apply to Ready-To-Go CMC Series
Updated 2006

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

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.
* 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)

Review Date: 2007




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