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Re: soccadoc post# 26503

Saturday, 09/15/2012 7:06:53 AM

Saturday, September 15, 2012 7:06:53 AM

Post# of 401059
So here is what we are given:
The Hong Kong-based Customer has informed us that it has been in business for more than five years and it has multiple FDA approved manufacturing sites outside of the United States.

From AP's website that Soccadoc provided it says:
"In 1983, APC acquired 60% of Loyal Advance Limited (“LAL”), a trading company which held several licenses to key top selling drugs which the Company viewed would assist it in increasing its penetration in the generic drug market. After the acquisition, LAL was transformed from a trading company into a pharmaceutical manufacturer. The Company continued to focus and grow its OEM manufacturing business and distribution of licensed products." (Check on the +5 Years)

"To meet its objectives, the Company has invested more than USD 10 million in developing a state-of-the-art production facility in Tai Po Industrial Estate, New Territories, Hong Kong. This new GMP plant was in full operation in April 2003 with advanced machineries and equipment from Germany." (Check on the multiple FDA approved manufacturing sites outside the US)

Now what I think makes this a rather likely candidate is what you point out Soccadoc...that "Their products Natsin, Naseco-F, Sinulax, Rhinobol Antihistamine Capsule, and the Nasalax Capsule are all BROMPHENIRAMINE BASED PRODUCTS."

~~~And this is what Jerry said about this a CC or two back: "If you go into a pharmacy around here and look for a brompheniramine product, you're probably not going to find it, because the reality is there just aren't really any on the market. And brompheniramine is a very effective antihistamine."

Excellent DD!! smile

What I am unsure of is given AP has several Branded products is the NDA with ELTP the same product they already have marketed in Hong Kong.....or will this be a completely new product??

I also got the impression that Elite would only be marketing this product in the US and not helping with manufacturing for the market outside the US??

See as follows:
On March 16, 2012, Elite Pharmaceuticals Inc. (“Elite”) executed a Development and License Agreement (“Agreement”) with a private Hong Kong-based company (the “Customer”) for Elite to develop for the Customer a branded prescription pharmaceutical product in the United States.
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