Due to many inquiries about this project, we put the detailed info here.
The Production of Paclitaxel Injection
21CEC provide highest quality Paclitaxel API (>99.5% Paclitaxel, USP26 standard) with low price, we Provide scientific and technology advice for the step-to-step production. We also can do Contract manufacturing in Switzerland or help your company to build your own Oncology Injection production line. In another words, we do have the expertise and capability to take care of the whole production procedure of Paclitaxel Injection - from raw material to finished products.
Paclitaxel is called "A billion dollar molecule". All its producers
gain huge profits.
How to do it by
yourself?
(1) Oncology products Production facilities -
Oncology products usually are cytotoxic agents. hence its production line should be separated to the normal production line.
To build the Paclitaxel production facilities cost about USD $3-5 millions and 6-12 months.
The production line (depends on your capital availability) ranging from the State-of-Art automatic assembly line with "Isolator technology" made in Europe, to low price good quality machinery made in P. R. China.
Paclitaxzel Injection Manufacturing
Facilities:
Space: 1,000 sq
meters.
(Sterile Area: 700 sq
meters.
Support area: 300 sq
meters.)
Staff:
10
people.
Equipments: Combined Injection
Production Line, Air filter / sterile System etc. (GMP
standard)
Capability: 1 million vials / per
year
Investment: USD $3-5 million (in
developing countries).
Construction
period: 6-12
months
(2) We provide Paclitaxel Injection Step-by-step Production Technolog . We also can send Supervising engineer visit your factory at your beginning stage of production.
(3) Your company need to prepare the proper space (total 1,000 sq meters) with 700 sq meters sterilization zone (Class 100 – Class 1,000 to meets GMP standard) for the location of Oncology Injection Production Line facility.
(4) Your company shall arrange the proper analysis laboratory, equipments and staff for the quality control of Paclitaxel Injection. (The Analysis laboratory equipments may be shared with other products).
(5) Your company should take care of the environment and staff health issues according the regulations of Iran government.
(6) Your compoany shall apply and obtain the Manufacturer license for Paclitaxel Injection in your country.
(7) Validation and Stability Test -
You have to do Stability Test of the Paclitaxel Injection first (usually 3 batches of each strength - 30mg and 100mg vials are the most popular ones). It will takes 12-24 months to collect the stability data for applying the marketing license. Once the Stability data is ready, then you can apply for its marketing license in your country.
To build an Oncology Injection Production facility, totally you'll need to invest USD $5 million and 3 years period to start production and marketing.
A short-cut way
- Contract
Manufacturing:
However a quick and easy way to invest less and get profits fast is Contract manufacturing: Our Contract Manufacturing site is in Switzerland with the highest quality and low price.
Paclitaxel Injection requires high technology to ensure no quality/recall problems in future. For your interest we recommend you atart in this way.
- The Stability Test data for 30mg and 100mg is available from our Contract manufacturer._ to pay an Upfront fee EURO 0.6 million, you can get the registration dossier and 10 samples instantly. This will save you 12 months stability test time and you can start registration in your country straight away.
- Commercial Production in your own Brand name _ The cost is EURO 25./per 30mg vial (inclusive API, vial, label, package as finished product). Minimum order 16,000 vials (EURO 0.4 million). Usually you order twice a year to cover your annual sales.
You need to give the production notice 3 months in advance. The product will be ready for you in 60 days once we received your upfront payment.
This is the most cost effective way, you can be the first generic Paclitaxel Injection in your country to occupy its market , and the product high quality is secured.
- The Profits -
Paclitaxel Injection is the best seller , about 22% of all anti-cancer drugs sold in this world.
Your country market probably 50,000 - 100,000 vials per year. The lowest market price of 30mg generic Paclitaxel Injection is at least USD $99./per 30mg vial.
Your profit will be over USD $60./per vial. If you sold 40,000 vials per year, the profit will be USD $2.4 million per year.
Your total invest is EURO 0.8 million and your first year
profit will be USD $2.4 million. That's
why people call Paclitaxel "A bilion dollar molecule".
Start from here, you will gain high return and occupy the market instantly. Then you can prepare to build your own Oncology Injection Production line.
Please do not
hesitate to contact with me, if you would further this business, we are always
here for you.
K regards
Dr. C.
Bleasdale
CEO, 21CEC Head Office
E mail: 21cec@21cec.com
Tel. (+44) 7732
971 307
