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CDRR-CGMP-5702
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JEWIM PHARMACEUTICAL (SHANDONG) CO.,LTD
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NO. 5, LEIGUSHI STREET, TAIAN HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE SHANDONG PROVINCE 271000, PEOPLES REPUBLIC OF CHINA
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SURESTEP PHARMACEUTICALS, INC.
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01 October 2025
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RENEWAL
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CDRR-CGMP-5704
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MANKIND PHARMA LIMITED
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VILLAGE KISHANPURA P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR 173025, HIMACHAL PRADESH, INDIA
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MEDETHIX, INC.
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09 May 2025
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RENEWAL
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CDRR-CGMP-5706
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EGIS GYOGYSZERGYAR ZRT.
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MATYAS KIRALY UTCA 65, KORMEND, 9900, HUNGARY
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DESPINA PHARMA INC.
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23 February 2027
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INITIAL
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CDRR-CGMP-5707
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EGIS GYOGYSZERGYAR ZRT.
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BOKENYFOLDI UT 118-120, BUDAPEST XVI, 1165, HUNGARY
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DESPINA PHARMA INC.
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06 December 2025
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INITIAL
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CDRR-CGMP-574
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KYUNG DONG PHARM CO., LTD.
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224-3, JEYAKDANJI-RO, YANGGAM-MYEON, HWASEONG-SI, GYEONGGI-DO, REPUBLIC OF KOREA
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KAUFMANN PHARMA INC.
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07 February 2025
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RENEWAL
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CDRR-CGMP-5751
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FRESENIUS KABI USA, LLC
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3159 STALEY ROAD, GRAND ISLAND, NY 14072 UNITED STATES OF AMERICA
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FRESENIUS KABI PHILIPPINES, INC.
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30 August 2026
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INITIAL
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CDRR-CGMP-5753
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STANTECH PHARMACEUTICALS PVT. LTD.
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D-186, MIDC RANJANGAON, TAL. SHIRUR, PUNE, INDIA 412 208
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MEDINOVA PHARMACEUTICAL INC.
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25 May 2026
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INITIAL
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CDRR-CGMP-5754
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LABORATORIOS LEON FARMA S.A.
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POLIGONO INDUSTRIAL NAVATEJERA, C/ LA VALLINA S/N, VILLAQUILAMBRE, 24193 LEON, SPAIN
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MEGA LIFESCIENCES LIMITED INC.
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15 January 2027
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INITIAL
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CDRR-CGMP-5755
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HEALTH BIOTECH LIMITED
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VILL. SANDOLI, NALAGARH ROAD, BADDI, HIMACHAL PRADESH, INDIA
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SAHAR INTERNATIONAL TRADING INC.
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13 June 2027
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INITIAL
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CDRR-CGMP-5756
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GMH ORGANICS UNIT-II
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PLOT NO. 01, VILL. KUNJHAL, JHARMAJRI, BADDI, DISTT. SOLAN (H.P.) – 173205, INDIA
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MEDINOVA PHARMACEUTICAL INC.
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10 February 2025
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INITIAL
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CDRR-CGMP-5757
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ALVOTECH HF.
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SAEMUNDARGOTU 15-19, REYKJAVIK, 102, ICELAND
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HYPHENS PHARMA PHILIPPINES, INC.
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13 January 2026
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INITIAL
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CDRR-CGMP-5758
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WASSERBURGER ARZNEIMITTELWERK GMBH
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HERDERSTRASSE 2, BURGERFELD, WASSERBURG A. INN, BAVARIA, 83512, GERMANY
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TAKEDA HEALTHCARE PHILIPPINES
INC.
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30 June 2025
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INITIAL
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CDRR-CGMP-5759
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EUROFINS BIOPHARMA PRODUCT TESTING COLUMBIA, INC.
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4780 DISCOVERY DRIVE, COLUMBIA, MO 65201, UNITED STATES OF AMERICA
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TAIHO PHARMA ASIA PACIFIC PTE. LTD. PHILIPPINE BRANCH
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12 August 2025
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INITIAL
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CDRR-CGMP-5760
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ABLE MEDICAL COMPANY LIMITED
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111 MOO 9, NONGSON, CHIANGYUEN, MAHASARAKHAM 44160,THAILAND
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EXA LIFE CARE PHARMA INC.
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09 July 2026
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INITIAL
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CDRR-CGMP-5761
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AAVIS PHARMACEUTICALS
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9488 JACKSON TRAIL ROAD, HOSCHTON, GA, USA
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AGLOBAL CARE, INC.
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09 April 2027
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INITIAL
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CDRR-CGMP-5762
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DEVA HOLDINGS A.S.
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ANKARA CADDESI, DUMLUPINAR MAH, NO:2, TR 41250 KARTEPE/KOCAELI/TURKIYE
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DEEL CORPORATION
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16 June 2025
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INITIAL
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CDRR-CGMP-5764
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LABORATORIOS PISA, S.A. DE C.V.
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CARRETERA SAN ISIDRO MAZATEPEC NO. 7000, EDIFICIO I, SANTA CRUZ DE LAS FLORES, C.P. 45640, TLAJOMULCO DE ZÚÑIGA, JALISCO, MEXICO
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EPIONE LIFECARE INC.
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07 February 2026
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INITIAL
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CDRR-CGMP-5765
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PENMIX LTD.
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33, GEORIMAK-GIL, JIKSAN-EUP, SEOBUK-GU, CHEONAN-SI, CHUNGCHEONGNAM-DO, REPUBLIC OF KOREA
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H & B PHARMA INTERNATIONAL INC.
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13 December 2026
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INITIAL
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CDRR-CGMP-5766
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GLOBELA LABORATORIES PRIVATE LIMITED
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PLOT NO. 5536 ROAD NUMBER 55, GIDC ESTATE SACHIN, SURAT, 394230, INDIA
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AMBICA INTERNATIONAL CORPORATION
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03 May 2025
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INITIAL
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CDRR-CGMP-5767
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LABORATORIOS PISA, S.A. DE C.V.
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CALLE 6 NO. 2924, COL. ZONA INDUSTRIAL, C.P. 44940. GUADALAJARA, JALISCO, MEXICO
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EPIONE LIFECARE INC.
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09 October 2026
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INITIAL
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