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Stocks are generally categorized according to their market capitalization and price value by the mar

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

ket players. Accordingly, we hear terms like large cap stocks, medium cap stocks and small cap stock

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

Examples of combination products may in

s. Shares with very small market cap (up to $100 million) and a maximum price value of up to $ 3 are

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

called penny stocks in the market jargon. These are usually cited as the opposite of blue chip share

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

s, which often carry a premium tag. Penny stocks are usually traded over the counter (OTC) by the br

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

Combination pro

kers because they are unable to list on exchanges due to their stringent norms.

For one thing, big

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

exchanges like the New York Stock Exchange (NYSE) and NASDAQ prefer top-of-the - line companies for

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

isting. More so because they too are keen to feed on reputation of the companies they trade in just

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

as the latter want to cash in on huge turnover volumes of these exchanges. Second, they also strictl

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

enforce compliance of their norms by the listed companies, meaning that those who fail to do so are

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

automatically de-listed. Such exchanges tend to evaluate performance record and caliber of top mana

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

Following aspects would a

gement of the company applying to list with them.

In contrast, penny stocks are mainly unlisted and

dd to the challenges in developing combination products:

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

traded outside exchanges. In other words, they are nondescript stocks with listless trading. Penny s

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

tocks mostly change hands between brokers, without getting much notice from common investors. This i

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

because this category of stocks is supposed to be risky due to lack of key information on the conce

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

rned companies, their promoters and management. Perhaps this is the reason why these stocks are so o

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

Professional from academic institutions, pharmaceutical industries, health care indust

ten targeted by investment scammers.

Nevertheless, penny stocks can also turn in unexpectedly big r

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

eturns if they rise on the fundamentals of the concerned company rather than any market manipulation

.

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

This is because most of the penny stocks are generally quite undervalued due to lack of market supp

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

Companies that provide selfless information through particip

ort. So, anyone who can lay his hands on the right penny stocks might reap unexpected gains some day

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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