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China wants to modernize its factories and get into the making of items, which do no

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

t produce a lot of pollution. They are looking for cleaner type industries such as

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

electronics and high-tech industry sub-sectors. What does this mean for the United S

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

tates of America? Well, it means the exporting of more jobs and more outsourcing.

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

It means that American companies will be able to utilize China's new manufacturing c

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

apabilities to make more high tech products and they will be able to save lots of mo

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ney because they will not bear the burden of over regulation, incessant lawsuits and

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

hard to deal with unions in the United States of America. Is it right for American c

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

orporations to outsource these manufacturing capabilities to China?

Really if the U

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

nited States wants to compete in the global market it will have to lower the prices

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

of the products it produces to compete with other countries. So, American corporati

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ons have a choice they can go and business or they can use China's manufacturing cap

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

abilities to compete and stay in business and still make a profit.

I ask a simple q

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

uestion for those who are upset with outsourcing. If you were out to you and it was

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

your company what would you do? Would you throw everything you had worked for away a

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

nd go out of business? Or would you migrate the manufacturing of your product to Chi

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

na to make it for 30% of what it cost you to make it in America today?

Let's face i

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

t 60% of all manufacturing costs are incurred due to over regulation, high labor cos

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ts and excessive lawsuits. What if you can cut all that out all at once? Make sens

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e to me from a business standpoint and there you have it. Consider all this in 2006

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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