Notice2025-23826

Hard Empty Capsules From India: Final Affirmative Determination of Sales at Less Than Fair Value

Primary source

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Published
December 29, 2025

Issuing agencies

Commerce DepartmentInternational Trade Administration

Abstract

The U.S. Department of Commerce (Commerce) determines that imports of hard empty capsules (capsules) from India are being, or are likely to be, sold in the United States at less than fair value (LTFV), as provided in section 735 of the Tariff Act of 1930, as amended (the Act), for the period of investigation (POI) October 1, 2023, to September 30, 2024.

Full Text

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<title>Federal Register, Volume 90 Issue 245 (Monday, December 29, 2025)</title>
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[Federal Register Volume 90, Number 245 (Monday, December 29, 2025)]
[Notices]
[Pages 60613-60616]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23826]


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DEPARTMENT OF COMMERCE

International Trade Administration

[A-533-934]


Hard Empty Capsules From India: Final Affirmative Determination 
of Sales at Less Than Fair Value

AGENCY: Enforcement and Compliance, International Trade Administration, 
Department of Commerce.

SUMMARY: The U.S. Department of Commerce (Commerce) determines that 
imports of hard empty capsules (capsules) from India are being, or are 
likely to be, sold in the United States at

[[Page 60614]]

less than fair value (LTFV), as provided in section 735 of the Tariff 
Act of 1930, as amended (the Act), for the period of investigation 
(POI) October 1, 2023, to September 30, 2024.

DATES: Applicable December 29, 2025.

FOR FURTHER INFORMATION CONTACT: Joseph Molokwu or Luke Caruso, AD/CVD 
Operations, Office IV, Enforcement and Compliance, International Trade 
Administration, U.S. Department of Commerce, 1401 Constitution Avenue 
NW, Washington, DC 20230; telephone: (202) 482-8043 or (202) 482-2081, 
respectively.

SUPPLEMENTARY INFORMATION:

Background

    On May 29, 2025, Commerce published in the Federal Register its 
preliminary affirmative determination in the LTFV investigation of 
capsules from India, in which it also postponed the final determination 
until October 14, 2025.\1\ On September 5, 2025, Commerce issued a 
post-preliminary analysis memorandum in which it made certain changes 
to its differential pricing analysis.\2\ We invited interested parties 
to comment on the Preliminary Determination and changes to the 
differential pricing analysis.\3\
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    \1\ See Hard Empty Capsules from India: Preliminary Affirmative 
Determination of Sales at Less Than Fair Value, Postponement of 
Final Determination and Extension of Provisional Measures, 90 FR 
22699 (May 29, 2025) (Preliminary Determination), and accompanying 
Preliminary Decision Memorandum (PDM).
    \2\ See Memorandum, ``Post-Preliminary Analysis for the 
Affirmative Determination in the Less-Than-Fair-Value Investigation 
of Hard Empty Capsules from India,'' dated September 5, 2025 (Post-
Preliminary Analysis).
    \3\ See Memorandum, ``Notification of Deadlines for the 
Submission of Case and Rebuttal Briefs,'' dated September 15, 2025.
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    Due to the lapse in appropriations and Federal Government shutdown, 
on November 14, 2025, Commerce tolled all deadlines in administrative 
proceedings by 47 days.\4\ Additionally, due to a backlog of documents 
that were electronically filed via Enforcement and Compliance's 
Antidumping and Countervailing Duty Centralized Electronic Service 
System (ACCESS) during the Federal Government shutdown, on November 24, 
2025, Commerce tolled all deadlines in administrative proceedings by an 
additional 21 days.\5\ Accordingly, the deadline for this final results 
determination is now December 18, 2025.
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    \4\ See Memorandum, ``Deadlines Affected by the Shutdown of the 
Federal Government,'' dated November 14, 2025.
    \5\ See Memorandum, ``Tolling of all Case Deadlines,'' dated 
November 24, 2025.
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    A summary of the events that occurred since Commerce published the 
Preliminary Determination, as well as a full discussion of the issues 
raised by parties for this final determination, may be found in the 
Issues and Decision Memorandum.\6\ The Issues and Decision Memorandum 
is a public document and is on file electronically via Enforcement and 
Compliance's Antidumping and Countervailing Duty Centralized Electronic 
Service System (ACCESS). ACCESS is available to registered users at 
<a href="https://access.trade.gov">https://access.trade.gov</a>. In addition, a complete version of the Issues 
and Decision Memorandum can be accessed directly at <a href="https://access.trade.gov/public/FRNoticesListLayout.aspx">https://access.trade.gov/public/FRNoticesListLayout.aspx</a>.
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    \6\ See Memorandum, ``Issues and Decision Memorandum for the 
Final Affirmative Determination in the Less-Than-Fair-Value 
Investigation of Hard Empty Capsules from India,'' dated 
concurrently with, and hereby adopted by, this notice (Issues and 
Decision Memorandum).
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Scope of the Investigation

    The products covered by this investigation are capsules from India. 
For a complete description of the scope of this investigation, see 
Appendix I.

Scope Comments

    In the Preliminary Scope Memorandum, we set aside a period of time 
for parties to raise issues regarding product coverage (i.e., scope) in 
scope-specific case briefs or other written comments.\7\ We received 
scope case and rebuttal briefs from multiple interested parties. For a 
summary of the product coverage comments and rebuttal responses 
submitted to the record for this final determination, and accompanying 
discussion and analysis of all comments timely received, see the Final 
Scope Memorandum.\8\ In the Final Scope Memorandum, Commerce determined 
that it is modifying the scope language as it appeared in the 
Initiation Notice.\9\ See Appendix I.
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    \7\ See Memorandum, ``Less-Than-Fair-Value and Countervailing 
Duty Investigations of Hard Empty Capsules from Brazil, the People's 
Republic of China, India, and the Socialist Republic of Vietnam: 
Scope Comments Decision Memorandum for the Preliminary 
Determination,'' dated March 24, 2025 (Preliminary Scope 
Memorandum).
    \8\ See Memorandum, ``Less-Than-Fair-Value and Countervailing 
Duty Investigations of Hard Empty Capsules from Brazil, the People's 
Republic of China, India, and the Socialist Republic of Vietnam: 
Final Scope Decision Memorandum,'' dated concurrently with this 
notice (Final Scope Memorandum).
    \9\ See Hard Empty Capsules From Brazil, the People's Republic 
of China, India, and the Socialist Republic of Vietnam: Initiation 
of Less-Than-Fair-Value Investigations, 89 FR 91684 (November 20, 
2024) (Initiation Notice).
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Verification

    Commerce conducted verification of the information relied upon in 
making its final determination in this investigation, in accordance 
with section 782(i) of the Act. Specifically, we conducted on-site 
verifications of the sales and cost information submitted by ACG 
Associated Capsules Private Limited (ACG India) and HealthCaps India 
Limited (HIL).\10\ We used standard verification procedures, including 
an examination of relevant sales and accounting records, and original 
source documents provided by ACG India and HIL.
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    \10\ See Memoranda, ``Verification of the Sales and Cost 
Responses of ACG Associated Capsules Private Limited in the Less 
Than Fair Value Investigation of Hard Empty Capsules from India,'' 
dated September 15, 2025, ``Verification of the Constructed Export 
Price Sales of ACG Associated Capsules Private Limited's U.S. 
Affiliate ACG North America LLC in the Less Than Fair Value 
Investigation of Hard Empty Capsules from India,'' dated September 
15, 2025, and ``Verification of the Sales and Cost Responses of 
HealthCaps India Limited in the Less Than Fair Value Investigation 
of Hard Empty Capsules from India,'' dated September 15, 2025.
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Analysis of Comments Received

    All issues raised in the case briefs submitted by interested 
parties in this investigation are addressed in the Issues and Decision 
Memorandum. A list of the issues addressed in the Issues and Decision 
Memorandum is attached to this notice as Appendix II.

Changes Since the Preliminary Determination

    We made certain changes to the dumping margin calculations for ACG 
India and HIL since the Preliminary Determination and Post-Preliminary 
Analysis. In addition, Commerce has relied on adverse facts available 
under sections 776(a) of the Act for ACG India. For a discussion of 
these changes, see the Issues and Decision Memorandum.

All-Others Rate

    Section 735(c)(5)(A) of the Act provides that Commerce shall 
determine an estimated all-others rate for all exporters and producers 
not individually examined. This rate shall be an amount equal to the 
weighted average of the estimated weighted-average dumping margins 
established for exporters and producers individually investigated, 
excluding any zero and de minimis dumping margins, and any margins 
determined entirely under section 776 of the Act.
    Commerce calculated individual estimated weighted-average dumping 
margins for ACG India and HIL that are not zero, de minimis, or based 
entirely on facts otherwise available. Publicly-ranged total U.S. sales 
values are not available for each of the companies examined in this 
investigation.

[[Page 60615]]

Therefore, Commerce calculated the estimated weighted-average dumping 
margin for all-other producers and exporters using a simple average of 
the estimated weighted-average dumping margins calculated for the 
examined respondents.\11\
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    \11\ With two respondents under examination, Commerce normally 
calculates: (A) a weighted-average of the estimated weighted-average 
dumping margins calculated for the examined respondents; (B) a 
simple average of the estimated weighted-average dumping margins 
calculated for the examined respondents; and (C) a weighted-average 
of the estimated weighted-average dumping margins calculated for the 
examined respondents using each company's publicly-ranged U.S. sales 
values for the merchandise under consideration. Commerce then 
compares (B) and (C) to (A) and selects the rate closest to (A) as 
the most appropriate rate for all other producers and exporters. 
See, e.g., Ball Bearings and Parts Thereof from France, Germany, 
Italy, Japan, and the United Kingdom: Final Results of Antidumping 
Duty Administrative Reviews, Final Results of Changed-Circumstances 
Review, and Revocation of an Order in Part, 75 FR 53661, 53662 
(September 1, 2010), and accompanying Issues and Decision Memorandum 
at Comment 1. Publicly-ranged total U.S. sales values are not 
available for each of the companies examined in this investigation. 
Accordingly, we cannot calculate an estimated weighted-average 
dumping margin based on a weighted-average to consider applying to 
the non-examined respondents in this investigation. Instead, we have 
determined to calculate the simple average of the estimated 
weighted-average dumping margins calculated for the examined 
companies to the companies not selected for individual examination 
in this investigation. For a complete analysis of the data, see 
Memorandum, ``Final Determination All-Others Rate Calculation,'' 
dated concurrently with this notice.
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Final Determination

    Commerce determines that the following estimated weighted-average 
dumping margins exist:
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    \12\ In the Preliminary Determination, Commerce preliminarily 
determined that these companies are a single entity. See Preliminary 
Determination PDM at 4-5; see also Memorandum, ``Preliminary 
Affiliation and Collapsing Analysis Memorandum,'' dated April 21, 
2025. No parties commented on this determination; thus, we continue 
to treat these companies as a single entity for purposes of this 
final determination.

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                                                                                              Cash deposit rate
                                                                      Estimated weighted-       (adjusted for
                        Exporter or producer                            average dumping      subsidy offset(s))
                                                                        margin (percent)          (percent)
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ACG Associated Capsules Private Limited; ACG Universal Capsules                      26.69                 19.71
 Private Limited; and Custom Capsules Private Limited \12\.........
HealthCaps India Limited...........................................                  10.66                  3.68
All Others.........................................................                  18.68                 11.70
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Disclosure

    Commerce intends to disclose the calculations and analysis 
performed in connection with this final determination to interested 
parties within five days of any public announcement or, if there is no 
public announcement, within five days of the date of publication of 
this notice in the Federal Register, in accordance with 19 CFR 
351.224(b).

Suspension of Liquidation and Cash Deposit Requirements

    In accordance with section 735(c)(1)(B) of the Act, we instructed 
U.S. Customs and Border Protection (CBP) to suspend liquidation of all 
entries of subject merchandise, as described in Appendix I of this 
notice, which were entered, or withdrawn from warehouse, for 
consumption on or after May 29, 2025, the date of publication of the 
Preliminary Determination in the Federal Register. In accordance with 
section 733(d) of the Act, we instructed CBP to discontinue the 
suspension of liquidation of all entries of subject merchandise entered 
or withdrawn from warehouse, on or after November 25, 2025, but to 
continue the suspension of liquidation of all entries of subject 
merchandise on or before November 24, 2025.
    If the U.S. International Trade Commission (ITC) publishes an 
affirmative final injury determination, then Commerce will publish an 
antidumping duty order, reinstate the suspension of liquidation under 
section 736(a) of the Act, and require a cash deposit of estimated 
antidumping duties for entries of subject merchandise in the amounts 
indicated above, in accordance with section 736(a) of the Act. If the 
ITC determines that material injury, or threat of material injury, does 
not exist, then this proceeding will be terminated, the suspension of 
liquidation will be lifted, and all cash deposits for estimated 
antidumping duties will be refunded.
    To determine the cash deposit rate, Commerce normally adjusts the 
estimated weighted-average dumping margin by the amount of export 
subsidies countervailed in a companion countervailing duty (CVD) 
investigation, when CVD provisional measures are in effect. 
Accordingly, where Commerce made an affirmative determination for 
countervailable export subsidies, Commerce would offset the estimated 
weighted-average dumping margins by the appropriate export subsidy 
rate.\13\ Any such adjusted cash deposit rates may be found in the 
``Final Determination'' section above. If the U.S. International Trade 
Commission (ITC) makes a final affirmative determination of injury due 
to both dumping and subsidies, then the cash deposit rate will include 
the offsets for the export subsidies collected as part of the CVD final 
determination.
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    \13\ See Preliminary Determination PDM at 18.
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ITC Notification

    In accordance with section 735(d) of the Act, Commerce will notify 
ITC of its final affirmative determination of sales at LTFV. Because 
Commerce's final determination is affirmative, in accordance with 
section 735(b)(2) of the Act, the ITC will make its final determination 
as to whether the domestic industry in the United States is materially 
injured, or threatened with material injury, by reason of imports or 
sales (or the likelihood of sales) of capsules for importation from 
India no later than 45 days after this final determination. If the ITC 
determines that such injury does not exist, then this proceeding will 
be terminated, all cash deposits posted will be refunded, and 
suspension of liquidation will be lifted. If the ITC determines that 
such injury does exist, then Commerce will issue an antidumping duty 
order directing CBP to assess, upon further instruction by Commerce, 
antidumping duties on all imports of the subject merchandise entered, 
or withdrawn from warehouse, for consumption on or after the effective 
date of the suspension of liquidation, as discussed in the '' 
Suspension of Liquidation and Cash Deposit Requirements'' section 
above.

Administrative Protective Order (APO)

    This notice serves as the only reminder to parties subject to an 
APO of their responsibility concerning the disposition of proprietary 
information disclosed under the APO in accordance with 19 CFR 
351.305(a)(3). Timely written notification of the return or destruction 
of APO materials or conversion to judicial protective order is

[[Page 60616]]

hereby requested. Failure to comply with the regulations and terms of 
an APO is a sanctionable violation.

Notification to Interested Parties

    This final determination and notice are issued and published in 
accordance with sections 735(d) and 777(i) of the Act, and 19 CFR 
351.210(c).

    Dated: December 18, 2025.
Christopher Abbott,
Deputy Assistant Secretary for Policy and Negotiations, performing the 
non-exclusive functions and duties of the Assistant Secretary for 
Enforcement and Compliance.

Appendix I

Scope of the Investigation

    The merchandise subject to the scope of this investigation is 
hard empty capsules, which are comprised of two prefabricated, 
hollowed cylindrical sections (cap and body). The cap and body 
pieces each have one closed and rounded end and one open end, and 
are constructed with different or equal diameters at their open 
ends.
    Hard empty capsules are unfilled cylindrical shells composed of 
at least 80 percent by weight of a water soluble polymer that is 
considered non-toxic and appropriate for human or animal consumption 
by the United States Pharmacopeia--National Formulary (USP-NF), Food 
Chemical Codex (FCC), or equivalent standards. The most common 
polymer materials in hard empty capsules are gelatin derived from 
animal collagen (including, but not limited to, pig, cow, or fish 
collagen), hydroxypropyl methylcellulose (HPMC), and pullulan.
    Hard empty capsules may also contain water and additives, such 
as opacifiers, colorants, processing aids, controlled release 
agents, plasticizers, and preservatives. Hard empty capsules may 
also be imprinted or otherwise decorated with markings.
    Hard empty capsules are covered by the scope of these 
investigations regardless of polymer material, additives, 
transparency, opacity, color, imprinting, or other markings.
    Hard empty capsules are also covered by the scope of these 
investigations regardless of their size, weight, length, diameter, 
thickness, and filling capacity.
    Cap and body pieces of hard empty capsules are covered by the 
scope of these investigations regardless of whether they are 
imported together or separately, and regardless of whether they are 
imported in attached or detached form.
    Hard empty capsules covered by the scope of these investigations 
are those that disintegrate in water, simulated intestinal fluid, 
simulated gastric fluid, or other similar water-based (i.e., 
aqueous) fluids within 2 hours under tests specified in Chapter 701 
of the USP-NF, or equivalent disintegration tests.
    Hard empty capsules are classifiable under subheadings 
9602.00.1040 and 9602.00.5010 of the Harmonized Tariff Schedule of 
the United States (HTSUS). In addition, hard empty capsules may be 
imported under HTSUS subheading 1905.90.9090; gelatin hard empty 
capsules may be imported under HTSUS subheading 3503.00.5510; HPMC 
hard empty capsules may be imported under HTSUS subheading 
3923.90.0080; and pullulan hard empty capsules may be imported under 
HTSUS subheading 2106.90.9998. Although the HTSUS subheadings are 
provided for convenience and customs purposes, the written 
description of the merchandise covered by these investigations is 
dispositive.

Appendix II

List of Topics Discussed in the Issues and Decision Memorandum

I. Summary
II. Background
III. Changes Since the Preliminary Determination
IV. Discussion of the Issues
    Comment 1: Whether Commerce Should Correct Certain Errors in Its 
Calculation of ACG's Estimated Weighted-Average Dumping Margin
    Comment 2: Whether Commerce Should Apply Adverse Facts Available 
(AFA) in Calculating ACG's Final Estimated Weighted-Average Dumping 
Margin
    Comment 3: Whether Commerce Improperly Rejected ACG North 
America LLC (ACG NA)'s Minor Correction of the Reported U.S. Duty 
Expenses
    Comment 4: Whether Commerce Should Apply AFA in Calculating 
HIL's Inland Freight from Warehouse to Customer Expenses
    Comment 5: Whether Commerce Has a Statutory Basis to Depart from 
the Average-to-Average (A-to-A) Comparison Method
V. Recommendation

[FR Doc. 2025-23826 Filed 12-23-25; 8:45 am]
BILLING CODE 3510-DS-P


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Indexed from Federal Register on December 29, 2025.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.