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OPEC stands for Organization of Petroleum Exporting Countries, and it was founded in 196

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

0. The members of OPEC include Algeria, Angola, Indonesia, Iran, Iraq, Kuwait, Libya, Ni

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

Examples of combination products may in

eria, Qatar, Saudi Arabia, United Arab Emirates, and Venezuela. OPEC has three separate

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

ategories for membership which include founder, full and associate. How does a country b

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

come a member? OPEC statute stipulates that "any country with a substantial net export

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

Combination pro

f crude petroleum, which has fundamentally similar interests to those of member countrie

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

s, may become a Full Member of the Organization, if accepted by a majority of three-four

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

hs of Full Members, including the concurring votes of all Founder Members".

In both Mar

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

h and September OPEC holds its bi-annual conference where it determines policy and polic

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

implementation. The members operate under principle of unanimity Each member receives

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

one vote. During this time the organization reviews applications for membership. It also

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

Following aspects would a

approves the appointment of Governors, votes on a Chairman of the Board, and reviews al

dd to the challenges in developing combination products:

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

matter concerning the board such as budgetary matters.

Saudi Arabia has the largest cr

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

de oil reserve followed by Iran, Iraq, Kuwait, United Arab Emirates, while Saudi Arabia

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

is the largest crude producer within the organization. Cumulatively, OPEC countries prod

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

ce 43% of the world’s crude oil and 18% of the world’s natural gas. OPEC oil exports acc

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

Professional from academic institutions, pharmaceutical industries, health care indust

ount for 51% of the crude of the traded around the world. Consequently, OPEC plays a si

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

nificant role in determining the price of crude oil based on the amount of oil produced.

.

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

Decisions made by OPEC to either increase or decrease oil production can cause upheaval

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

Companies that provide selfless information through particip

n the market. These changes have a ripple effect which extends into all consumer markets

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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