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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	eFile (Ab)
1	Alendronate Sodium US & EU	Tablets	5 - 10 mg	B	1/3 of cost
2	Alendronate Sodium	Tablets	40 / 80mg	B	1/3 of cost
3	Aluminium Magnesium	Suspension	-	A	1/3 of cost
4	Amitriphyline HCl	Tablets	10 mg	A	1/3 of cost
5	Azithromycin US & EU	Suspension	200 mg	B	1/3 of cost
6	Azithromycin	Capsules	250	B	1/3 of cost
7	Azithromycin	Tablets	500 & 600	B	1/3 of cost
8	Atenolol + Chlorthalidone (Soon)	Tablets	100-50/25	B	1/3 of cost
9	Atenolol US / EU	Tablets	50 /100 mg	B	1/3 of cost
10	Amoxicillin	Capsules	250 & 500	B	1/3 of cost
10	Ampicillin Na & Sulbactam Na	Injection	1g + 0.5g 2g + 1g	B	1/3 of cost
11	Bisoprolol Fumerate / HCTZ=ZIAC	Tablets	5, 10, 25 + 6.25 mg	C	1/3 of full cost
12	Bromhexine Hydrochloride	Tablets + Syrup	8mg	B	1/3 of cost
13	Bromocriptine Mesylate	Tablets	2.5mg	B	1/3 of cost
14	Bupropion US & EU	Tablets	75/100 mg	B	1/3 of cost
15	Buspirone HCl US & EU	Tablets	5 mg /10 mg	B	1/3 of cost
16	Carbamazepine = Geigy US & EU	Tablets	200mg	B	1/3 of cost
17	Carbamazepine = Geigy ChewTabs	ChewTabs	100 mg	C	1/3 of cost
18	Carbamazepine (Extended Release) Geigy TEGRATOL 400 mg XR™	ER Coated Tab	400 mg	C	1/3 of cost
19	Carbidopa/Levodopa US & EU	Tablets	10/100 mg	B	1/3 of cost
20	Carbidopa/Levodopa US & EU	Tablets	25/100 mg	B	1/3 of cost
[List 1] [List 2] [List 3] [List 4] [List 5]

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

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% 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 is available for developers who would prefer to review the abbreviated commercial formula and summary outline 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 : 2018/19