21 C.F.R. § 510.600
(c) The names, addresses, and drug labeler codes of sponsors of approved new animal drug applications are as follows:
| 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 |
| 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. |
Editorial Note:For Federal Register citations affecting § 510.600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.
[40 FR 13807, Mar. 27, 1975]