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

§ 510.600 Names, addresses, and drug labeler codes of 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 Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 057561
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112 017762
Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788 011788
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
Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777 062250
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
Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 068330
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., Sy No-99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, 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
Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, FRANCE 086189
ECO LLC, 344 Nassau St., Princeton, NJ 08540 066916
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 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 Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109 064950
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
Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538-7084 063604
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, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155 086064
Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104 086149
Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509 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., 776 Mountain Blvd., Watchung, NJ 07069 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 Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 066794
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
Provetica LLC, 8735 Rosehill Rd., Suite 300, Lenexa, KS 66215 086097
Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126-2910 017800
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia 086132
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, Inc., 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
Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062 027053
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
Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901 086106
United-AH II LLC, 322 S Main St., Sheridan, IN 46069 051233
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
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, Inc., 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.
027053 Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062.
037990 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.
042552 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069.
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, 961 Beasley St., suite 270, Lexington, KY 40509.
051072 Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009.
051079 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478.
051233 United-AH II LLC, 322 S Main St., Sheridan, IN 46069.
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.
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.
057561 Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503.
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., 2500 Innovation Way, Greenfield, IN 46140.
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.
062250 Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777.
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.
063604 Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538-7084.
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.
066794 Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017.
066916 ECO LLC, 344 Nassau St., 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.
068330 Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767.
068504 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia.
069043 Cronus Pharma Specialities India Private Ltd., Sy No-99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, 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.
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, 4300 SW 73rd Ave., suite 110, Miami, FL 33155.
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.
086097 Provetica LLC, 8735 Rosehill Rd., Suite 300, Lenexa, KS 66215.
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., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, 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.
086189 Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, FRANCE.
099207 Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
[40 FR 13807, Mar. 27, 1975]
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.