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ANI Pharmaceuticals, Inc.

210 Main Street West

Baudette, Minnesota 56623

January 6, 2023

Division of Corporation Finance

Office of Life Sciences

United States Securities and Exchange Commission

100 F Street, N.E.

Washington, D.C. 20549

 Re: ANI Pharmaceuticals, Inc.

Form 10-K for Fiscal Year
Ended December 31, 2021

Filed March 15, 2022

Form 8-K furnished August
8, 2022

File No. 001-31812

Ladies and Gentlemen:

Set forth below are the responses
of ANI Pharmaceuticals, Inc. (the “Company,” “ANI,” “we,” “us” or “our”) to
comments received from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission
(the “Commission”) by letter, dated December 12, 2022. For your convenience, each response is prefaced by the exact text of
the Staff’s corresponding comment in bold, italicized text.

Form 8-K Furnished November 9, 2022

Table 3: Adjusted non-GAAP EBITDA Calculation
and US GAAP to Non-GAAP

Reconciliation, page Table 3

 1. We note your non-GAAP adjustment for In-process research and development in the three months ended
September 30, 2022. We believe the adjustment is inconsistent with Question 100.01 of the Non-GAAP Financial Measures Compliance and Disclosure
Interpretation. Please confirm to us you will no longer include the adjustment in any non-GAAP financial measure presented in accordance
with Item 10(e) of Regulation S-K or Regulation G.

RESPONSE: We acknowledge your comment
and in our future Form 8-K filings, earnings releases and other presentations that include non-GAAP financial measures, for all periods
presented, we will no longer adjust for in-process research and development expense in the calculation of our Adjusted Non-GAAP EBITDA,
Non-GAAP Research and Development Expense, and Adjusted Non-GAAP Diluted Earnings per Share. We will recast prior period information to
conform to current year presentation. In addition, we will provide a footnote to the non-GAAP reconciliation tables addressing the change
as compared to previously furnished information; please refer to our response to question 3 below for draft language.

    1

Correspondence dated December 5, 2022

Non-GAAP
Financial Measures, page 6

 2. You state in response to comment 1 that in connection with the November 2021 acquisition of Novitium
Pharma LLC you acquired a fourth pharmaceutical manufacturing plant. During the integration of Novitium you determined that three manufacturing
plants would support your manufacturing capacity needs and you thus decided to close the Canada plant and move the majority of production
being undertaken in Canada to the remaining U.S. based manufacturing plants. As the operations appear to be continuing, although at a
different manufacturing facility, it is unclear why it is appropriate to include a non-GAAP adjustment for the Canada operations. Please
confirm you will revise your presentation in the future, or clarify to us further why you believe revenues and expenses relating to products
previously manufactured at the Canada facility will not continue at the new manufacturing facility.

RESPONSE: We appreciate the
opportunity to further clarify our position regarding our non-GAAP adjustment of Canadian operations. While 13 of the products
historically manufactured in Canada have been moved to other manufacturing facilities, the revenues and corresponding cost of goods
sold for those products have not been subject to adjustment in our presentation of non-GAAP financial measures. We have
only adjusted for aspects of running the Canada operations that will not recur once the closure of the Canada facility is
complete (expected to be March 31, 2023). The below details are intended to clarify this point.

ANI’s principal business is the
manufacture, marketing, and sale of pharmaceutical products in its own label to direct wholesale and retail customers (sales of
 ‘ANI Labeled Product’). For the nine months ended September 30, 2022, $202.9 million, or 91.3%, of our total net
revenues of $222.2 million were derived from sales of ANI Labeled Product. We also derive revenues from contract development and
manufacturing activities (‘CDMO’), where ANI manufactures pharmaceutical products on behalf of other pharmaceutical companies (‘CDMO
Product’). During the same nine-month period we generated $12.1 million, or 5.4%, of our total revenues from CDMO
activities.

Our Canada manufacturing facility has historically
performed two core activities: a) the manufacture of ANI Labeled Product on behalf of ANI parent company and b) the manufacture of CDMO
Product for third party customers. During the nine months ended September 30, 2022, third party sales of CDMO Product generated from Canada
operations was $2.7 million of the $12.1 million contract manufacturing revenues reported. Revenues related to third party sales of ANI
Labeled Product are not recorded by the Canada operations. Instead, they are accounted for as intercompany sales to the U.S. parent
company and eliminated in our consolidated results. Subsequent third-party sales of ANI labeled inventory manufactured by Canada is recognized
by the U.S parent company and presented as Generic pharmaceutical product revenue in our GAAP financial statements and disclosures (see
page 47 of MD&A in our third quarter Form 10-Q as filed on November 8, 2022).

    2

From an operational perspective, at the
onset of 2022, ANI had excess manufacturing capacity in its manufacturing network of four manufacturing facilities. This excess
capacity created the opportunity for us to close one facility, which was determined to be our Canada operations. Importantly,
each of our facilities has available capacity to absorb more volume, and thus the transfer of Canada manufacturing to one of the
remaining three facilities will not result in any incremental costs or headcount at the receiving facilities in functions that are
being adjusted for in our non-GAAP measures. While direct manufacturing labor expense utilized to produce ANI Labeled product is
being transferred from Canada to other facilities, we have not adjusted out expenses related to direct manufacturing of ANI
Labeled Product that will be on-going post Canada closure. This detail is further discussed below.

The following details the approximate size and
capacity of our four manufacturing facilities:

    Manufacturing Site
    Square Footage
    Annual Solid Dose

 Capacity

    Main Street, Baudette, MN
      130,000
    2.5 billion doses

    Containment facility, Baudette, MN
      47,000
    2.5 billion doses

    East Windsor, NJ
      120,000
    3.0 billion doses

    Canada operations
      101,000
    1.0 billion doses

Canada was producing approximately 120 million
doses per year, a volume that is readily absorbed into the Main Street and East Windsor facilities.

During the nine-month period ended September 30,
2022:

 - ANI sold approximately 109 product families of ANI Labeled Product.

 - Of this amount, 16 product families were manufactured in Canada. Of this amount, we have moved production
to our other manufacturing facilities for thirteen and the remaining three products families have been discontinued.

 - ANI sold approximately 30 product families of CDMO Product of which eight were manufactured in Canada.
ANI has discontinued its contracts and will no longer manufacture these products on behalf of CDMO customers post closure of our Canada
operations.

 - ANI had approximately 600 employees of which approximately 128 were employees of our Canada
                                                          operation. After the closure of Canada, all but one employee will be terminated with no increase in headcount at our remaining
                                                          facilities in functions that are being adjusted for in our non-GAAP financial measures. For completeness: the one employee retained by ANI was repurposed into a pre-existing U.S. opening for an IT systems implementation.

    3

More specifically, we are only adjusting for
what we believe to be the non-recurring portion of Canada operations. The following is a summary of statement of operations line
items for Canada operations and their treatment for purposes of our reported non-GAAP financial measures beginning with our second
quarter 2022 financial statements:

    P&L Line Item
    Non-recurring?

    Adjusted in Non-GAAP Measure?

    Third Party CDMO Revenue and Costs of Sales (‘COS’)
    Yes; CDMO contracts have been cancelled and manufacturing will cease; third party revenues and related COS will not recur post Canada closure
    Yes

    ANI Labeled Product Revenue and COS recorded by Parent company
    No; revenue streams and related direct costs to manufacture will continue for 13 of 16 product families. Labor, overhead and input costs will move from Canada to U.S. and thus are recurring.
    No

    SG&A
    Yes; all Canada based activities will cease and Canada employees will be terminated with no increase in expense or headcount at the remaining facilities
    Yes

    Research & Development
    Yes;
    Canada only performed R&D for its CDMO customers therefore all Canada based activities will cease and Canada employees will be
    terminated with no  increase in expense or headcount at the remaining facilities
    Yes

The Canada closure remains on track to be
completed by the originally disclosed date of March 31, 2023. In fact, as of the date of this response, all manufacturing activities
are complete.

Lastly, ANI does not have a history of undertaking
significant restructurings. The June 2022 announcement of the closure of the Canada operations is the first action in the Company’s
history as a public company to warrant presentation on the face of our GAAP Statement of Operations as a restructuring. Given the materiality
of the annual losses being generated at the Oakville facility relative to our overall company profitability metrics commonly utilized
to communicate with the analyst and investor community ($7 - $8 million of annualized savings announced on June 2, 2022, as compared to
projected full year 2022 adjusted non-GAAP EBITDA of $54 - $60 million at the time) and the unique (for ANI) nature of the action, we
believe that the presentation of our non-GAAP measures as a supplement to our GAAP financial results further enhances the disclosures
contained in our Form 10-Q and highlights the impact of the actions being undertaken of our results of operations.

Our intent is that the above details will provide
the Staff further context and support for the Company's position that the amounts being adjusted in our non-GAAP measures are non-recurring
and that activities that are to be recurring are not being adjusted in our non-GAAP measures. In addition, that the adjustments presented
for Canada operations are directly attributable to the decision to close the facility, are incremental to our normalized operations and
based directly on amounts recorded in our GAAP financial statements. In order to further clarify these items for the users of our financial
statements and financial disclosures, we will edit the existing footnote to the non-GAAP reconciliation tables to read as follows:

“Impact of Canada operations includes CDMO revenues, cost of
sales relating to CDMO revenues, all selling, general and administrative expenses, and all research and development expenses recorded
in Canada in the period presented, exclusive of restructuring activities, stock-based compensation and depreciation and amortization,
which are included within their respective lines above. The adjustment of Canada operations represents revenues, cost of sales and expense
that will not recur after the completion of the closure of our Canada operations, expected to be complete by March 31, 2023. The adjustment
of Canada operations does not adjust for revenues, cost of sales, and expense that will recur at our other manufacturing facilities after
the transfer of certain manufacturing activities is complete.”

In addition, we will clarify in our “Restructuring” footnote
to our financial statements as well as in any applicable sections of MD&A that we have cancelled the CDMO contracts that were previously
being supplied from the Canada operations.

We appreciate the opportunity to further clarify our position regarding
our non-GAAP adjustment of Canadian operations and welcome further engagement with the Staff if there are further questions or clarifications
warranted.

    4

 3. We acknowledge your response to comment 2. Although you are no longer adjusting for Cortrophin pre-launch
charges and sales and marketing expenses, we continue to believe that the non-GAAP adjustments in prior periods are not appropriate since
these costs are normal costs incurred in your business to achieve FDA approval, regardless of whether or not regulatory approval is ultimately
obtained. Please confirm you will revise to eliminate these adjustments in future filings or tell us why these costs are different from
costs incurred by other companies in your industry to obtain regulatory approval.

RESPONSE:
To further clarify our previous response, the $13.5 million of Sales, General and Administrative pre-launch sales and marketing
expenses for Cortrophin that were adjusted in our non-GAAP results for the twelve months ended December 31, 2021, were related to establishing
our sales and marketing team and launch strategy and were not related to achieving FDA approval. Costs related to achieving FDA approval
for Cortrophin were recorded to the Research and Development expense and are fully recognized in both our GAAP and non-GAAP results in
2021.

Nonetheless, we acknowledge your comment and in
our future Form 8-K filings, earnings releases and other presentations that include non-GAAP financial measures, for all periods presented,
we will no longer adjust for pre-launch charges and sales and marketing expenses in the calculation of our Adjusted Non-GAAP EBITDA,
Non-GAAP SG&A Expense, and Adjusted Non-GAAP Diluted Earnings per Share. We will recast prior period information to conform to current
year presentation.

In addition, we will provide the following footnote
to the non-GAAP reconciliation tables addressing both this change and the change for IPR&D in response number 1 above:

“Beginning in the fourth quarter of 2022,
ANI will no longer exclude expenses for In-Process Research & Development or Cortrophin pre-launch charges and sales and marketing
expenses from its non-GAAP results. Historically, the company excluded these charges. These changes
are being made at the request of the U.S. Securities and Exchange Commission.
Prior periods have been recast to reflect these changes.

- For the period ended December 31, 2022, non-GAAP
financial measures have been recast to include $1.15 million of incremental R&D expense and a related reduction in full year Adjusted
non-GAAP Diluted Earnings per Share of $0.06 as compared to amount reported in our third quarter 2022 earnings release and associated
Form 8-K.

- For the period ended December 31, 2021, non-GAAP
results have been recast to include $780K of additional Purified Cortrophin Gel pre-launch charges and $13.4 million of Cortrophin related
SG&A expense, and a related reduction in full year Adjusted non-GAAP Diluted Earnings per Share of $0.86, resulting in a revised 2021
Adjusted non-GAAP Diluted Earnings per Share of $2.36.”

*       *       *       *       *

    5

Should you have any questions with respect to the
foregoing or if any additional supplemental information is required by the Staff, please contact Meredith W. Cook, SVP, General Counsel
and Corporate Secretary of ANI Pharmaceuticals, Inc. at 609-759-1810 ext. 1001.

    Sincerely,

    ANI Pharmaceuticals, Inc.

    By:
    /s/ Stephen P. Carey

    Name:
    Stephen P. Carey

    Title:
    Senior Vice President Finance and Chief Financial Officer