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

NOTE : EULA and IAGIM Rules / Regulations apply to Ready-To-Go CMC Series
Updated Period : 2009 -2010

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% - 75% 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 to a full 1/4) of the above price structures are available for developers who would prefer to review the commercial formula and process before purchasing the complete full length print volume. The print cost then reduced by the abbreviated efile amount paid.

SINGLE DOSE & MULTIDOSE DOSE COSTING
* Single dose (lowest $ amount) and multi dose (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 : 2009 - 2010

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