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'Hapus' and 'alphonso' mangoes are grown mostly in the Rantagiri district of Maharashtra, a sta

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

te of India. They are called the kings of mangoes. The taste is pure, deliciously sweet and fib

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

Examples of combination products may in

ous yet very soft. The look is green-brownish-pinkish. The shape is a delight to the beholder a

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

d the size fits the palm.

The mango season begins in around April in this western state of Ind

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

ia when the price remains very high—about $10 a dozen. In June-July it falls to tolerable level

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

Combination pro

. Mango festivals are organized in Mumbai around this season where growers from different regio

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 of the state open their stalls of the priciest mangoes and sell at wholesale rates. Folks thr

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

ong such festivals and try for a good bargain. Here dozen rates are not so much adhered to. The

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

customers look for a 'peti', that is, a straw padded wooden case of rows of mangoes sealed tigh

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

ly that can be bought at bulk rates.

The newsroom of a local TV channel got the news that 'hap

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

s' mangoes are being exported to America after a long break of 18 years. That was big news. It

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

Following aspects would a

occupied the headline slots for whole of that day. It was newsworthy and also sentimental as it

dd to the challenges in developing combination products:

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

evoked a sense of pride among the local media personnel.

Two days later there was a shortage o

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

hard news and it was becoming very difficult to manage the mandatory three headlines for a bul

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

letin ten minutes and above. The chief reporter discovered something and rushed to the editor g

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

shing out, “Sir, 'hapus' mangoes in America! We’ve got our headline!”

“That was two days ago.

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

Professional from academic institutions, pharmaceutical industries, health care indust

e made full use of it. No way!”

“No Sir! The mangoes have reached America!”

“Are you crazy? Y

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

ou mean to say we make another headline that the mangoes have reached America now; and then we

.

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

o on making headlines how many American people have devoured how many mangoes on a daily basis!

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

Companies that provide selfless information through particip

Don’t get too patriotic, man! Now, get rid of that 'mangola' mania and hunt for some hard news!

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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