SecProbe.io

October 18, 2011
 Mr. Elliot Maza Chief Executive Officer Biozone Pharmaceuticals, Inc. 550 Sylvan Avenue Suite 101 Englewood Cliffs, NJ 07632
Re: Biozone Pharmaceuticals, Inc.
Registration Statement on Form S-1 Filed September 21, 2011
  File No. 333-176951

Dear Mr. Maza:

We have reviewed your registration statem ent and have the following comments.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.
 Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe  our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
 After reviewing any amendment to your re gistration statement and the information you
provide in response to these comments, we may have additional comments.
 Registration Statement on Form S-1

 General

1. Since you are a reporting company subject to th e requirements of the Securities Exchange
Act of 1934, you should respond to the comments  in this letter that apply to the
disclosure included in your Form 10-K or  Form 10-Q within ten business days by
providing the requested information or by advising us when you will provide the requested response.  A few examples of disclosu re that is required to  be included in your
registration statement and your Form 10-K or Form 10-Q include Business section, Risk
Factors, Director and Offi cer disclosure, Beneficial Ownership Table, MD&A and
Financial Statements and the notes thereto.  Please review the re quirements of Forms 10-
K and 10-Q for a detailed list of the require d disclosure as compared to Form S-1.

Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 2

 2. Please note that where we provide examples to illustrate what we mean by our comments,
they are examples and not complete lists. If our comments are appli cable to portions of
the filing that we have not cited as examples, please make the appropriate changes in
accordance with our comments.
3. We note your disclosure in footnote 1 to the registration fee table that pursuant to Rule
416, the shares of Common stock offered hereby also include an indeterminate number of
additional shares of Common stock as may fr om time to time become issuable by reason
of anti-dilution provisions, stock splits, stock dividends, recapitalizati ons or other similar
transactions.  Rule 416(a) involves the regist ration of additional securities “being offered
or issued to prevent dilution resulting from  stock splits, stock dividends or similar
transactions.”  Please revise to remove the shares that may be issuable by reason of “anti-
dilution provisions” as they are not covered by Rule 416.

4. Please define the terms FDA and cGMP in the first instance that you use each
abbreviation.
5. Please define the terms iontophoresis and pegylat ed in the first inst ance that you use each
term.
Prospectus Summary, page 3

6. Please expand your Prospectus Summary to id entify and describe your marketed products
and the product candidates in your pipeline. For the product candidate s in your pipeline,
please clearly state that these product candi dates have not been approved by regulatory
authorities, may never be approved, and descri be each product candidate ’s progress in the
approval process.
7. Please expand your disclosure throughout to  clearly disclose the products that you
manufacture and the products that ar e manufactured by third parties.

8. Please expand your description of BioZone Technology to briefly to explain how you
developed your technology platfo rm and intellectual pr operty.  To the extent that this was
developed in-house, pl ease so indicate.

Special Note Regarding Forwar d Looking Statements, page 6

9. You state on page 6 that this prospectus c ontains forward-looking statements within the
meaning of Section 21E of th e Securities Exchange Act of 1934.  Please note that issuers
of penny stock are excluded from relyi ng upon the safe harbor for forward-looking
statements pursuant to Section 21E(b)(1)(iii) .  Please remove this reference from your
disclosure.

Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 3

 Risk Factors, page 6

10. In the introductory paragraph to the Risk Factors section, you stat e that “[t]here are
numerous and varied risks, known and unknown, that may prevent us from achieving our
goals.  If any of these risks actually occur, our business, fi nancial condition or results of
operations may be materially adversely affected.”  As th e risk factors section should
contain a complete discussion of  the material risks to your bu siness, it is inappropriate to
reference risks that are not disclosed in your  risk factors section.  Please revise the
introductory paragraph accordingly.
11. Please add a risk factor addre ssing your lack of profitable ope rations in recent periods.
Please discuss in this risk factor whether you expect your financial lo sses to continue in
the future.
12. Please add a risk factor describing the risk to  your company of relyi ng on third parties to
manufacture your products.
“We have negative working capital and have sustained operating losses . . .,” page 6

13. Please expand this risk factor to estimate th e amount of time you will be  able to continue
operations with your current level of working capital.

14. You state that you “cannot be sure how much [you] will need to spend in order to
develop new products and technologies in the future.”  Please estimate the amount of
funds you will need to complete devel opment of your product candidates upon which
your business is substantially dependent  and identify the product candidates.

15. You disclose that the report of your independent registered  public accounting firm on
your financial statements states that your ab ility to obtain profitability and necessary
equity or debt financing raise substantial doubt about your ability to continue as a going
concern. This risk appears to be distinct from the other risks discussed in this risk factor.
Please revise your disclosure to add a separate ly headed risk factor that discussed this
risk.  In addition, please expand your risk f actor to disclose that the auditor’s going
concern opinion may have a detrimental effect on your ability to obtain additional funding.
“We operate in a highly regulated industry. . . .,” page 6

16. This risk factor appears to disc uss a risk to the company that is substantially similar to the
risk discussed in the risk fact or on page 9 entitled, “If we fail to obtain or maintain the
necessary United States or wo rldwide regulatory approvals . . . .”  Please revise your
disclosure to either distinguish the risks and the headers thereof or combine these two
discussions.

Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 4

 17. You disclose that “The FDA inspected our manufacturing facilities in January 2011. The
inspection resulted in only minor observati ons on Form 483, which we quickly resolved
to FDA’s satisfaction.” Please disclose the date in which the FDA determined that the deficiencies were remedied and th e facility was in compliance.
 “Our future results of operations depend, to a si gnificant degree, upon our ability . . .,” page 7

18. You state that “[t]he development and comme rcialization process, particularly with
respect to innovative products, is both time consuming and costly and involves a high
degree of business risk.”  Pl ease expand this discussion to estimate the amount of time
and resources it takes to develop and commercialize a product candidate.

19. Please expand this risk factor to briefly describe your product pi peline in clinical
development.  Please indicate each product candidate’s progress in the development
process.
 “Lack of availability of, or significant increases  in the cost of raw materials . . .,” page 7

20. You state that previously unknown problem s with the raw materials or product
manufacturing processes could result in a voluntary or mandatory withdrawal of the
contaminated product.  To the extent you ha ve experienced problems with contaminated
products in the recent past, please revise to describe these problems.
 “Our future results of operations depend, to a significant degree . . .,” page 8

21. This risk factor appears to substantially dupl icate the risk factor with the same title on
page 7.  Please revise your disclosure to either distinguish the risks and the headers
thereof or combine these risk factors.
 “In order to achieve succe ssful sales of new product candidates . . .,” page 9

22. This risk factor duplicates the risk factor with  the same title on page 8.  Please revise your
disclosure to delete this risk factor.
 “Our product candidates may be subject to fu ture product liability claims. . . .,” page 10

23. Please expand your disclosure to quantify th e extent of your product liability insurance
coverage.
 “Our future collaborators may compete with  us or have interests . . .,” page 11

24. You state that “[l]arge pharm aceutical companies that [you] seek to collaborate with may
have internal programs or enter into collaborati ons with [your] competitors . . . .”  Please
update this risk factor to clar ify whether or not you are in negotiations for a collaboration

Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 5

 agreement. If you have entered into negotiati ons with any pharmaceutical companies for
collaboration agreements, please disclose  this in the Business section.
 “A dispute concerning the infringement  or misappropriation . . .,” page 12

25. If you have or have had any claims against you alleging infringement, please so disclose
in this risk factor.
“Confidentiality agreements with employees and others may not ad equately prevent . . .,” page
12

26. You indicate that you maintain confidentia lity and intellectua l property assignment
agreements with your employees and other persons with access to your proprietary
materials or processes.  Pleas e provide the Staff with a suppl emental copy of the standard
confidentiality agreement and the intellectual property as signment agreement you enter
into with your employees.  We may have further comment.
 “Our technology may become obsolete or lose its competitive advantage,” page 12

27. Please provide a detailed analysis to suppor t your assertion that  your technology has a
“competitive advantage.”

28. Please expand this risk factor to identif y your major competitors, the methods of
competition, and the main products of your competitors that will compete with your
products.
29. Please add a risk factor that discusses the risks to your business of the competition faced
by your marketed products.
“We rely on key executive officers and consultants . . .,” page 12

30. You state that you rely heavily on “certain ot her key executives,” ot her than those named
in this risk factor.  Please expand your di sclosure to name all key executives upon which
your business is dependent.
31. If any of your executives are working less than full time for your business, or have
business interests that conflict with  your business, please so disclose.

32. Please disclose that all employment agreements have a term of three ye ars.  In addition, if
Mr. Fisher is a “certain othe r key executive” upon which your bus iness is reliant, please
disclose that you have also entered into an  employment agreement with Mr. Fisher.

33. You state that you are competing with for em ployees against companies that are more
established than you are, and have the ability to pay more  cash compensation than you

Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 6

 do.  To the extent that you have experien ced problems hiring employees in the recent
past, please describe these problems.
“We cannot assure you that our common stock will become listed . . .,” page 13

34. Please note that NYSE Euronext acquired  the American Stock Exchange in 2008.
Accordingly, please revise all references to the American St ock Exchange, in this risk
factor and on page 39, to re ference NYSE Amex Equities.

35. Please estimate when you will seek listing of your common stock on the NYSE Amex
Equities or Nasdaq. For example, if you believe  that it may be several years or more until
your seek listing, pl ease so disclose.

36. Please describe the initial lis ting standards of a register ed stock exchange that you
currently fail to meet.
37. You disclose “we would be subject to an SEC rule….” Please revise to clarify the
following:
 whether or not you are currently subject to the rule;
 which SEC rule you refer to in this risk factor that imposes requirements on broker-
dealers who sell securities governed by the rule; and
 describe the requirements in the rule.

“We will incur increased costs as a result of being an operating public company,” page 13

38. We note that you are currently an operating publ ic company, please revise this risk factor
to tailor the risks discussed to your specifi c business and operating history.  In addition,
to the best of your ability, please quantify th e legal, accounting, and other expenses that
you will incur as a result of being an operating public company over the next 12 months.
 “Our common stock may be subject to the ‘Pen ny Stock’ rules of the SEC . . .,” page 14

39. Please clearly state that your stoc k is currently a “Penny Stock.”

40. Please expand this risk factor to discuss th e effect on liquidity, specific legal remedies
available to investors of penny stocks, and how such remedies would affect your
business.
 “We have never paid nor do we expect in th e near future to pay dividends,” page 14

41. Please clearly state in this risk  factor that reader s should not rely on an investment in your
company if they require dividend income, a nd income to them would only come from
any rise in the market price of your st ock, which is uncertain  and unpredictable.

Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 7

 “We and our security holders are not subject to some reporting requirements . . .,” page 14

42. Please briefly describe the contents of pr oxy and information statements, as well as
Forms 3, 4 and 5 reporting Section 16 compliance, so that investors may understand their purposes.
 “Our business may require additional capital  for continued growth . . .,” page 14

43. We note your disclosure that your ability to execute your operating plan depends upon
your ability to obtain additional funding via the sale of equity and/or debt securities.
Please revise your risk factor to clarify th at you need this funding.  In addition, please
disclose whether you have approached any sources for additional funding, or have
entered into negotiations  for a transaction.

44. Please expand your disclosure to inform invest ors that the issuance of equity securities
will dilute your current investors’ interest  in the company and the issuance of debt
securities may provide such holders rights superior to existing shareholders and
conditions on the company and its business.
“If we fail to establish and maintain an effectiv e system of internal c ontrol, . . .,” page 15

45. Your disclosure in this risk f actor is not consistent with your  disclosure regarding internal
controls over financial reporting and disclosure controls and procedures contained in your
annual report and quarterly reports on Form s 10-K and 10-Q.  Please update this risk
factor to discuss the material weaknesses disc losed in those reports and the related risks
to your business.
 “We may fail to qualify for continued listi ng on the OTC Bulletin Board . . .,” page 15

46. If you have failed in the recent past to m eet a requirement to qualify for continued
quotation on the OTCBB, please ex pand this risk factor to so  disclose, and describe the
listing requirement you failed to meet.
 “Investor relati