locumusa.com - Ready To Go Handbook Series, complete documentation Chemistry

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 : 2018/19