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21 CFR 510.600: Names, addresses, and drug labeler codes of sponsors of approved applications.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
  4. PART 510—NEW ANIMAL DRUGS
  5. Subpart G—Sponsors of Approved Applications

(a) Section 512(i) of the act requires publication of names and addresses of sponsors of approved applications for new animal drugs.

(b) In this section each name and address is identified by a numerical drug labeler code. The labeler codes identify the sponsors of the new animal drug applications associated with the regulations published pursuant to section 512(i) of the act. The codes appear in the appropriate regulations and serve as a reference to the names and addresses listed in this section. The drug labeler code is established pursuant to section 510 of the act.

(c) The names, addresses, and drug labeler codes of sponsors of approved new animal drug applications are as follows:

(1) Alphabetical Listing of Sponsors

Firm name and address Drug labeler code

A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527 057699

Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 07065 016729

ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 012286

Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112 017762

Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788 011788

Ajenat Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Suite 210, Largo, FL 33777 082983

Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031 059399

Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210 069334

American Regent, Inc., Animal Health Division, Shirley, NY 11967 010797

Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801 060865

Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808 086121

Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043 086073

AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754 086053

Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009 051072

Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France 086009

B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756 067188

Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807 099207

Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland 061133

Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 000010

Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France 013744

Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland 061651

Cronus Pharma Specialities India Private Ltd., Plot No.9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India 069043

Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom 043264

Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 017033

Diamond Animal Health, Inc., 2538 SE 43rd St., Des Moines, IA 50327 053701

Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, FRANCE 086189

ECO LLC, 506 Carnegie Centre, Suite 400, Princeton, NJ 08540 066916

Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46221 058198

Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928 017135

Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, Dublin 1, Ireland 086101

First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 058829

Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747 025463

Genus plc, 1525 River Road, Deforest, WI 53532 086205

GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702 042976

Happy Jack, Inc., Snow Hill, NC 28580 023851

Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964 063075

Hikma Pharmaceuticals USA, Inc., 2 Esterbrook Ln., Cherry Hill, NJ 08003 086194

HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652 042791

Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria 016592

IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 000115

Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 07065 000061

Ishihara Sangyo Kaisha, Ltd., 3-15, Edobori 1-chome, Nishi-ku, Osaka 550-0002, Japan 064642

Ivaoes Animal Health, 1200 NW 78th, Suite 200-D, Doral, FL 33126 086064

Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104 086149

Kinetic Technologies, LLC, 1700 Albany Pl SE, Orange City, IA 51041 051031

Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 061690

Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 054925

Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432 086039

Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186 015914

Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478 051079

Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505 063286

Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120 049968

Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 059051

Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751 086119

Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom 055529

Orion Corp., Orionintie 1, 02200 Espoo, Finland 052483

Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia 068504

Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 055246

Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970 050057

Pharmacosmos, Inc., 120 Headquarters Plz., Morristown, NJ 07960 042552

Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway 015331

Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 069254

Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 066104

Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India 065085

Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil 060728

Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126-2910 017800

Qbiotics Group Ltd., Level 14, 15 Lakes Street, Cairns, Queensland, QLD4870, Australia 086132

Qilu Animal Health Products Co., Ltd., No. 10688, Wenliang Road, Dongjia Town, Licheng District Jinan, Shandong, 250100, China 086163

Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 076475

Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060 086134

Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001 067949

Sergeant's Pet Care Products LLC, 10077 S. 134th St., Omaha, NE 68138 021091

Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 058005

Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151 017153

Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752 037990

Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248 050378

Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532 051672

Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503 052923

TriviumVet, Unit 3A, Cleaboy Business Park, Old Kilmeaden Road, Waterford, Waterford, X91 H5FE, Ireland 086169

Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901 086106

VetDC, Inc., 320 E. Vine Dr., suite 218, Fort Collins, CO 80524 086072

Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5 059320

Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137 017030

Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161 051311

Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin 2, Dublin, D02HX82, Ireland 066679

Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616 086113

Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550 053923

Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 054771

ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 086117

(2) Numerical Listing of Sponsors

Drug labeler code Firm name and address

000010 Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096.

000061 Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 07065

000115 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.

010797 American Regent, Inc., Animal Health Division, Shirley, NY 11967.

011788 Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788.

012286 ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115.

012578 Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

013744 Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France.

015331 Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway.

015914 Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186.

016592 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria.

016729 Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 07065.

017030 Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137.

017033 Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211.

017135 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928.

017153 Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151.

017762 Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112.

017800 Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126-2910.

021091 Sergeant's Pet Care Products LLC, 10077 S. 134th St., Omaha, NE 68138

023851 Happy Jack, Inc., Snow Hill, NC 28580.

025463 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747.

037990 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.

042552 Pharmacosmos, Inc., 120 Headquarters Plz., Morristown, NJ 07960.

042791 HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652.

042976 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702.

043264 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom.

049968 Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120.

050057 Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970.

050378 Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.

051031 Kinetic Technologies, LLC, 1700 Albany Pl SE, Orange City, IA 51041.

051072 Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009.

051079 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478.

051311 Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161.

051672 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532.

052483 Orion Corp., Orionintie 1, 02200 Espoo, Finland.

052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503.

053701 Diamond Animal Health, Inc., 2538 SE 43rd St., Des Moines, IA 50327.

053923 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550.

054771 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.

054925 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861.

055246 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.

055529 Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom.

057699 A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527.

058005 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215.

058198 Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46221

058829 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123.

059051 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.

059320 Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5.

059399 Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031.

060728 Planalquimica Industrial Ltda., Rua das Magnolias nr. Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Alto, Brazil.

060865 Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801.

061133 Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland.

061651 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland.

061690 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601.

062794 Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478.

063075 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964.

063286 Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505.

064642 Ishihara Sangyo Kaisha, Ltd., 3-15, Edobori 1-chome, Nishi-ku, Osaka 550-0002, Japan.

064950 Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109.

065085 Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India.

066104 Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666.

066679 Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin 2, Dublin, D02HX82, Ireland.

066916 ECO LLC, 506 Carnegie Centre, Suite 400, Princeton, NJ 08540

067188 B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756.

067949 Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001.

068504 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia.

069043 Cronus Pharma Specialities India Private Ltd., Plot No.9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India.

069254 Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.

069334 Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210.

076475 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349.

082983 Ajenat Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Suite 210, Largo, FL 33777

086009 Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France.

086039 Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432.

086053 AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754.

086064 Ivaoes Animal Health, 1200 NW 78th, Suite 200-D, Doral, FL 33126.

086072 VetDC, Inc., 320 E Vine Dr., suite 218, Fort Collins, CO 80524.

086073 Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043.

086101 Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, Dublin 1, Ireland.

086106 Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901.

086113 Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.

086117 ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534.

086119 Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751.

086121 Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808.

086132 Qbiotics Group Ltd., Level 14, 15 Lakes Street, Cairns, Queensland, QLD4870, Australia.

086134 Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060.

086149 Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104.

086163 Qilu Animal Health Products Co., Ltd., No. 10688, Wenliang Road, Dongjia Town, Licheng District Jinan, Shandong, 250100, China

086169 TriviumVet, Unit 3A, Cleaboy Business Park, Old Kilmeaden Road, Waterford, Waterford, X91 H5FE, Ireland.

086189 Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, FRANCE.

086194 Hikma Pharmaceuticals USA, Inc., 2 Esterbrook Ln., Cherry Hill, NJ 08003

086205 Genus plc, 1525 River Road, Deforest, WI 53532

099207 Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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