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., 1009 Slater Rd., suite 210–B, Durham, NC 27703 | 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., 1009 Slater Rd., suite 210–B, Durham, NC 27703. |
| 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.