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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 USD eFile (Ab)
59B

TRAMADOL HCl & ACETAMINOPHEN

Tablets
325 mg
+ 37.5 mg
D
1/3 of D
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


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 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.



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