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	<title>PILMAN &#187; cGMP</title>
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		<title>A New Facet of ‘Data Integrity’ With Novel Therapy… And Much Beyond</title>
		<link>http://www.tapanray.in/a-new-facet-of-data-integrity-with-novel-therapy-and-much-beyond/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=a-new-facet-of-data-integrity-with-novel-therapy-and-much-beyond</link>
		<comments>http://www.tapanray.in/a-new-facet-of-data-integrity-with-novel-therapy-and-much-beyond/#comments</comments>
		<pubDate>Mon, 30 Sep 2019 00:00:52 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[AveXis]]></category>
		<category><![CDATA[cancer]]></category>
		<category><![CDATA[cGMP]]></category>
		<category><![CDATA[cherry-picking]]></category>
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		<guid isPermaLink="false">http://www.tapanray.in/?p=9728</guid>
		<description><![CDATA[The peril of breach of data integrity involving a top Indian pharma player, jolted many, probably for the first time, on September 17, 2008. On that day, the USFDA, reportedly, issued two ‘Warning Letters’ and an ‘Import Alert’. These were related to &#8230; <a href="http://www.tapanray.in/a-new-facet-of-data-integrity-with-novel-therapy-and-much-beyond/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<item>
		<title>Even Smaller Countries Now Question Indian Drug Quality Standard</title>
		<link>http://www.tapanray.in/even-smaller-countries-now-question-indian-drug-quality-standard/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=even-smaller-countries-now-question-indian-drug-quality-standard</link>
		<comments>http://www.tapanray.in/even-smaller-countries-now-question-indian-drug-quality-standard/#comments</comments>
		<pubDate>Sun, 04 Dec 2016 23:42:26 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[bans]]></category>
		<category><![CDATA[CDSCO]]></category>
		<category><![CDATA[cGMP]]></category>
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		<category><![CDATA[Ray]]></category>
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		<category><![CDATA[smaller]]></category>
		<category><![CDATA[Standard]]></category>
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		<category><![CDATA[Tapan Ray]]></category>
		<category><![CDATA[USFDA]]></category>
		<category><![CDATA[Vietnam]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=8001</guid>
		<description><![CDATA[India has over 135 US-FDA approved pharmaceutical manufacturing units, at present. This number is very significant ranking second behind the United States, and was driving the growth of generic drug exports in the top pharma market of the world. Riding &#8230; <a href="http://www.tapanray.in/even-smaller-countries-now-question-indian-drug-quality-standard/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>PE Investment In Pharma: The Changing Need Of Due Diligence</title>
		<link>http://www.tapanray.in/pe-investment-in-pharma-the-changing-need-of-due-diligence/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=pe-investment-in-pharma-the-changing-need-of-due-diligence</link>
		<comments>http://www.tapanray.in/pe-investment-in-pharma-the-changing-need-of-due-diligence/#comments</comments>
		<pubDate>Mon, 02 May 2016 00:00:19 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[Business]]></category>
		<category><![CDATA[cGMP]]></category>
		<category><![CDATA[companies]]></category>
		<category><![CDATA[DCGI]]></category>
		<category><![CDATA[Directors]]></category>
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		<category><![CDATA[due diligence]]></category>
		<category><![CDATA[equity]]></category>
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		<category><![CDATA[generic]]></category>
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		<category><![CDATA[manufacturing]]></category>
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		<category><![CDATA[PE]]></category>
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		<category><![CDATA[Tapan Ray]]></category>
		<category><![CDATA[UCPMP]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=7621</guid>
		<description><![CDATA[From an international perspective, a Bain &#38; Company report of April 2016 highlighted setting a new healthcare M&#38;A record in the year 2015. During this year the total deal value was over 2.5 times higher than the average annual deal value &#8230; <a href="http://www.tapanray.in/pe-investment-in-pharma-the-changing-need-of-due-diligence/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>“Make in India…Sell Anywhere in The World”: An Indian Pharma Perspective</title>
		<link>http://www.tapanray.in/make-in-indiasell-anywhere-in-the-world-an-indian-pharma-perspective/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=make-in-indiasell-anywhere-in-the-world-an-indian-pharma-perspective</link>
		<comments>http://www.tapanray.in/make-in-indiasell-anywhere-in-the-world-an-indian-pharma-perspective/#comments</comments>
		<pubDate>Mon, 29 Sep 2014 00:00:10 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[2014]]></category>
		<category><![CDATA[Africa]]></category>
		<category><![CDATA[alert]]></category>
		<category><![CDATA[anywhere]]></category>
		<category><![CDATA[branded]]></category>
		<category><![CDATA[Bureau]]></category>
		<category><![CDATA[CDSCO]]></category>
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		<category><![CDATA[data]]></category>
		<category><![CDATA[day]]></category>
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		<category><![CDATA[export]]></category>
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		<category><![CDATA[generic]]></category>
		<category><![CDATA[global. world]]></category>
		<category><![CDATA[Harvard]]></category>
		<category><![CDATA[import]]></category>
		<category><![CDATA[in]]></category>
		<category><![CDATA[independence]]></category>
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		<category><![CDATA[Indian]]></category>
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		<category><![CDATA[warning]]></category>
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		<guid isPermaLink="false">http://www.tapanray.in/?p=6039</guid>
		<description><![CDATA[In his Independent Day speech from the ramparts of the Red Fort on August 15, 2014, Indian Prime Minister Modi gave a clarion call to all investors of the world, “Come, make in India”, “Come, manufacture in India”, “Sell in &#8230; <a href="http://www.tapanray.in/make-in-indiasell-anywhere-in-the-world-an-indian-pharma-perspective/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Drugs From The Same Indian Plant: Safe For Europe, Unsafe For America, Why?</title>
		<link>http://www.tapanray.in/drugs-from-the-same-indian-plant-safe-for-europe-unsafe-for-america-why/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=drugs-from-the-same-indian-plant-safe-for-europe-unsafe-for-america-why</link>
		<comments>http://www.tapanray.in/drugs-from-the-same-indian-plant-safe-for-europe-unsafe-for-america-why/#comments</comments>
		<pubDate>Mon, 09 Jun 2014 00:00:37 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[America]]></category>
		<category><![CDATA[AstraZeneca]]></category>
		<category><![CDATA[cGMP]]></category>
		<category><![CDATA[commissioner]]></category>
		<category><![CDATA[conspiracy]]></category>
		<category><![CDATA[Diovan]]></category>
		<category><![CDATA[drugs]]></category>
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		<category><![CDATA[Europe]]></category>
		<category><![CDATA[Hamburg]]></category>
		<category><![CDATA[India]]></category>
		<category><![CDATA[Lipitor]]></category>
		<category><![CDATA[Margaret]]></category>
		<category><![CDATA[nexium]]></category>
		<category><![CDATA[Novartis]]></category>
		<category><![CDATA[Pfizer]]></category>
		<category><![CDATA[Pharmaceuticals]]></category>
		<category><![CDATA[plant]]></category>
		<category><![CDATA[Ranbaxy]]></category>
		<category><![CDATA[Ray]]></category>
		<category><![CDATA[regulators]]></category>
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		<category><![CDATA[Sun]]></category>
		<category><![CDATA[Tapan]]></category>
		<category><![CDATA[Theory]]></category>
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		<category><![CDATA[unsafe]]></category>
		<category><![CDATA[US]]></category>
		<category><![CDATA[USA]]></category>
		<category><![CDATA[USFDA]]></category>
		<category><![CDATA[why]]></category>
		<category><![CDATA[wockhardt]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=5493</guid>
		<description><![CDATA[Good number of stories on US-FDA banning several drug manufacturing facilities of major domestic players of India over serious quality related issues, have been doing the rounds since about a year and almost at a regular interval. The quagmire has &#8230; <a href="http://www.tapanray.in/drugs-from-the-same-indian-plant-safe-for-europe-unsafe-for-america-why/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>The Takeover Magician To Tango Again On A Bold New ‘Sunny’ Tune</title>
		<link>http://www.tapanray.in/the-takeover-magician-to-tango-again-on-a-bold-new-sunny-tune/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=the-takeover-magician-to-tango-again-on-a-bold-new-sunny-tune</link>
		<comments>http://www.tapanray.in/the-takeover-magician-to-tango-again-on-a-bold-new-sunny-tune/#comments</comments>
		<pubDate>Mon, 14 Apr 2014 00:00:39 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[AIOCD]]></category>
		<category><![CDATA[ANDA]]></category>
		<category><![CDATA[AstraZeneca]]></category>
		<category><![CDATA[AWACS]]></category>
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		<category><![CDATA[Diovan]]></category>
		<category><![CDATA[India]]></category>
		<category><![CDATA[IPM]]></category>
		<category><![CDATA[magic]]></category>
		<category><![CDATA[magician]]></category>
		<category><![CDATA[nexium]]></category>
		<category><![CDATA[Novartis]]></category>
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		<category><![CDATA[PIL]]></category>
		<category><![CDATA[Ranbaxy]]></category>
		<category><![CDATA[Ray]]></category>
		<category><![CDATA[Sankyo]]></category>
		<category><![CDATA[Shanghvi]]></category>
		<category><![CDATA[Sun]]></category>
		<category><![CDATA[sunny]]></category>
		<category><![CDATA[Supreme]]></category>
		<category><![CDATA[takeover]]></category>
		<category><![CDATA[Tapan]]></category>
		<category><![CDATA[US-FDA]]></category>
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		<category><![CDATA[wand]]></category>
		<category><![CDATA[wockhardt]]></category>
		<category><![CDATA[Zydus]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=5240</guid>
		<description><![CDATA[The consolidation process of the Indian pharmaceutical industry continues in its own pace. Most recently, the homegrown pharma takeover magician is all set to tango yet again with a bold ‘Sunny’ tune. The low profile creator of high value ‘Sun &#8230; <a href="http://www.tapanray.in/the-takeover-magician-to-tango-again-on-a-bold-new-sunny-tune/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		</item>
		<item>
		<title>Loss of Ranbaxy, Gain of Big Pharma…And Two Intriguing Coincidences</title>
		<link>http://www.tapanray.in/loss-of-ranbaxy-gain-of-big-pharmaand-two-intriguing-coincidences/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=loss-of-ranbaxy-gain-of-big-pharmaand-two-intriguing-coincidences</link>
		<comments>http://www.tapanray.in/loss-of-ranbaxy-gain-of-big-pharmaand-two-intriguing-coincidences/#comments</comments>
		<pubDate>Mon, 17 Mar 2014 00:00:17 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[Actos]]></category>
		<category><![CDATA[big]]></category>
		<category><![CDATA[CBI]]></category>
		<category><![CDATA[cGMP]]></category>
		<category><![CDATA[coincidences]]></category>
		<category><![CDATA[Court]]></category>
		<category><![CDATA[Diovan]]></category>
		<category><![CDATA[double]]></category>
		<category><![CDATA[gain]]></category>
		<category><![CDATA[Government]]></category>
		<category><![CDATA[Hypothesis]]></category>
		<category><![CDATA[India]]></category>
		<category><![CDATA[Lipitor]]></category>
		<category><![CDATA[loss]]></category>
		<category><![CDATA[Machiavellian]]></category>
		<category><![CDATA[murkier]]></category>
		<category><![CDATA[Mylan]]></category>
		<category><![CDATA[nexium]]></category>
		<category><![CDATA[pharmaceutical]]></category>
		<category><![CDATA[Ranbaxy]]></category>
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		<category><![CDATA[Sun]]></category>
		<category><![CDATA[Supreme]]></category>
		<category><![CDATA[Tapan]]></category>
		<category><![CDATA[two]]></category>
		<category><![CDATA[USFDA]]></category>
		<category><![CDATA[Whammy]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=5096</guid>
		<description><![CDATA[In March 2014, the largest pharma player of India by market capitalization, Sun Pharma, became the latest of the large Indian pharma exporters facing the US-FDA ‘Import Ban’ for drugs manufactured at its Gujarat-based plant. This news came as a &#8230; <a href="http://www.tapanray.in/loss-of-ranbaxy-gain-of-big-pharmaand-two-intriguing-coincidences/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Threats to Indian Generics: Failing in US Inspections is Just Half The Story</title>
		<link>http://www.tapanray.in/threats-to-indian-generics-failing-in-us-inspections-is-just-half-the-story/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=threats-to-indian-generics-failing-in-us-inspections-is-just-half-the-story</link>
		<comments>http://www.tapanray.in/threats-to-indian-generics-failing-in-us-inspections-is-just-half-the-story/#comments</comments>
		<pubDate>Wed, 26 Feb 2014 09:44:41 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[cGMP]]></category>
		<category><![CDATA[Cleveland]]></category>
		<category><![CDATA[clinic]]></category>
		<category><![CDATA[commissioner]]></category>
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		<category><![CDATA[failing]]></category>
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		<category><![CDATA[half]]></category>
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		<category><![CDATA[Lipitor]]></category>
		<category><![CDATA[Margaret]]></category>
		<category><![CDATA[Ohio]]></category>
		<category><![CDATA[Pharmaceuticals]]></category>
		<category><![CDATA[prescriptions]]></category>
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		<category><![CDATA[Wellbutrin XL]]></category>
		<category><![CDATA[wockhardt]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=5027</guid>
		<description><![CDATA[At a recent event of the American Enterprise Institute, Dr. Harry Lever, a senior cardiologist at the Cleveland Clinic in Ohio, reportedly expressed his concern based on his personal experience regarding inconsistent quality among Indian generics. As a result, he requires switching patients &#8230; <a href="http://www.tapanray.in/threats-to-indian-generics-failing-in-us-inspections-is-just-half-the-story/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		</item>
		<item>
		<title>Are We Taking Safe and Effective Medicines?</title>
		<link>http://www.tapanray.in/are-we-taking-safe-and-effective-medicines/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=are-we-taking-safe-and-effective-medicines</link>
		<comments>http://www.tapanray.in/are-we-taking-safe-and-effective-medicines/#comments</comments>
		<pubDate>Wed, 13 Nov 2013 06:49:42 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[abbott]]></category>
		<category><![CDATA[alkem]]></category>
		<category><![CDATA[cGMP]]></category>
		<category><![CDATA[controllers]]></category>
		<category><![CDATA[DCGI]]></category>
		<category><![CDATA[drugs]]></category>
		<category><![CDATA[effective]]></category>
		<category><![CDATA[Glenmark]]></category>
		<category><![CDATA[GuruFcure]]></category>
		<category><![CDATA[India]]></category>
		<category><![CDATA[intas]]></category>
		<category><![CDATA[Pharmaceuticals]]></category>
		<category><![CDATA[Ray]]></category>
		<category><![CDATA[safe]]></category>
		<category><![CDATA[State]]></category>
		<category><![CDATA[Tapan]]></category>
		<category><![CDATA[tardy]]></category>
		<category><![CDATA[unichem]]></category>
		<category><![CDATA[USFDA]]></category>
		<category><![CDATA[wockhardt]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=4258</guid>
		<description><![CDATA[The above headline is in no way intended to mean that this discussion is on spurious or counterfeit drugs. Today’s deliberation is on the licensed drugs, which are manufactured in India, for the patients of the country, by the manufacturers &#8230; <a href="http://www.tapanray.in/are-we-taking-safe-and-effective-medicines/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>USFDA &#8216;Import Bans&#8217;: The Malady Calls For Strong Bitter Pills</title>
		<link>http://www.tapanray.in/usfda-import-bans-the-malady-calls-for-strong-bitter-pills/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=usfda-import-bans-the-malady-calls-for-strong-bitter-pills</link>
		<comments>http://www.tapanray.in/usfda-import-bans-the-malady-calls-for-strong-bitter-pills/#comments</comments>
		<pubDate>Mon, 11 Nov 2013 00:00:42 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[483]]></category>
		<category><![CDATA[adulterated]]></category>
		<category><![CDATA[alert]]></category>
		<category><![CDATA[Ankleshwar]]></category>
		<category><![CDATA[Arcolab]]></category>
		<category><![CDATA[bans]]></category>
		<category><![CDATA[Bitter]]></category>
		<category><![CDATA[CDSCO]]></category>
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		<category><![CDATA[chikalthana]]></category>
		<category><![CDATA[consequences]]></category>
		<category><![CDATA[conspiracy]]></category>
		<category><![CDATA[data]]></category>
		<category><![CDATA[defend]]></category>
		<category><![CDATA[Dewas]]></category>
		<category><![CDATA[Diovan]]></category>
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		<category><![CDATA[export]]></category>
		<category><![CDATA[Form]]></category>
		<category><![CDATA[fraud]]></category>
		<category><![CDATA[fudging]]></category>
		<category><![CDATA[generic]]></category>
		<category><![CDATA[GMP]]></category>
		<category><![CDATA[import]]></category>
		<category><![CDATA[indefensible]]></category>
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		<category><![CDATA[Patent]]></category>
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		<category><![CDATA[warning]]></category>
		<category><![CDATA[wockhardt]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=4197</guid>
		<description><![CDATA[It is a matter of pride that Indian pharmaceutical industry is the second largest exporter of drugs and pharmaceuticals globally, generating revenue of around US$ 13 billion in 2012 with a growth of 30 percent (Source: Pharmexcil). Though sounds awkward, &#8230; <a href="http://www.tapanray.in/usfda-import-bans-the-malady-calls-for-strong-bitter-pills/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
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