TITLE 21
READY-TO-GO CMC SERIES

GENERIC DRUG DEVELOPMENT CMC KNOW-HOW LIST


Contents of a Ready-To-Go Dossier

RTG DRUG PRODUCT FORM Strength USD Sterling
80 Naproxen Sodium US/EU
DR Tablets
220 mg
C
C
81 Naproxen Sodium US/EU
DR Tablets
275 / 550mg
C
C
82 Norfloxacin USP
Tablets
400 mg
B
B
83 Ofloxacin (= TARAVID) US/EU
Tablets
100/200/400 mg
C
C
84 Oxolamine
Syrup
10 mg/mL
B
B
86 Paclitaxel Conc. for Injection (vials)
6mg/mL
30+100mg
F
F
86 Paracetamol - Alcohol Free + sugar free / + dye-free
Clear Syrup
Clear Liquid
A non-suspension preparation
80/120/125 mg
Strawberry Flavour
B
B
86 Paracetamol - Alcohol Free + sugar free / + dye-free
Clear Syrup
Clear Liquid
A non-suspension preparation
80/120/125 mg Fruit Flavour
B
B
87 Paracetamol Chewable Fruit Flavors
ChewTabs
160 mg
B
B
88 Pentoxifylline( = Hoechst 400 XL)
ER Tablets
400 mg
C
C
89 Penfluridol
Capsules
10 mg
B
B
90 Potassium Chloride 600+1200 mg
SR Tablets
10+20 mEq
D
D
91 Piroxicam US/EU
Capsules
20 mg
A
A
92 Quinidine Bisulphate Tetrahydrate
Tablets
250 mg
A
A
93 Ranitidine HCl
Tablets
150/300 mg
B
B
94 Simvastatin US/EU
Tablets
5 / 10mg
B
B
95 Simvastatin US/EU
Tablets
20 / 40 / 80mg
C
C
96 Scopolamine Butylbromide
Tablets
10 mg
A
A
97 Selegiline US/EU
Tablets
5 /10 mg
A
A
98 Sotalol ( = Betapace™/ Berlex)
Tablets
US/EU
80/120/160 240 mg
C
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 $
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.



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