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China's focus is to become the manufacturer to the world. Their rate of expansion is 15% or higher over the last few ye

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

ars and is maxing out many of the resources of the country and world. Commodity prices for metal, concrete and other na

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

Examples of combination products may in

tural resources have skyrocketed. Chinese power plants can not produce enough electricity to keep up with the industria

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

l production that is going on in their country.

What is their secret to such prolonged manufacturing growth? First and

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

most important, the government in Beijing decided many years ago that if China was going to be a world power. They wil

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

Combination pro

l need to manufacture goods. They saw it work in Japan and obviously, they knew it worked in the United States.

They k

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

new they had a technologically advanced workforce. Factories had been manufacturing electronic components since the 70

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

's and early 80's. Not only are the Chinese technologically advanced, they are a very hard working culture.

So to spee

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

d up up their progress, they put a plan in place to grow as fast as possible. In order to do that, they invited manufac

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

turers from Taiwan to establish plants in mainland China. Many manufacturing operations in China started with relativel

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

small sales and now produce $500 million to $ 1 billion in sales in less than 15 years. It's incredible! The Chinese

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

Following aspects would a

government has made their mission to be "The Manufacturer to the World". It's working. I wonder why the United States

dd to the challenges in developing combination products:

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

government does not place more value on our manufacturing expertise?

Second, the Chinese people work very hard, six d

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

ays a week, 10-14 hours per day. There is a tremendous amount of incentive for them to work hard. For many, the qualit

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

y of their lives and the lives of their family can increase many times over.

Third, the timing is perfect. Technologi

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

cal advancement in machine tools has made it easy for anyone to make products faster, cheaper, better. As more products

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

Professional from academic institutions, pharmaceutical industries, health care indust

are being made and being shipped worldwide, transportation costs are reduced. Products are being manufactured all ove

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

r the globe, sometimes in the most unlikely places creating a "virtual unlimited supply".

Manufacturing has become a co

.

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

re competency. Niches are being carved out in all corners of the globe. China has uncovered the secret to creating a

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

Companies that provide selfless information through particip

powerful economy and country. China has uncovered a big secret. But I don't think the US Government will ever find out

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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