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List of Certificates of Suitability (CEPs) for Excipients issued by EDQM. Original Data: EDQM Database

CEP/COS

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01 BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN (5)

02 NANJING WELL PHARMACEUTICAL GROUP CO., LTD. Nanjing CN (1)

03 ANHUI SUNHERE PHARMACEUTICAL EXCIPIENTS CO., LTD. Huainan CN (1)

04 ASAHI GELATINE INDUSTRIAL CO., LTD. Himeji JP (1)

05 AVESTA PHARMA PVT. LTD. Mumbai IN (1)

06 Ambrogio Pagani SpA Bergamo IT (2)

07 BASF SE Ludwigshafen DE (5)

08 BHOPAL GLUES & CHEMICALS PRIVATE LIMITED Bhopal IN (1)

09 CARGILL S.R.L. DIVISIONE AMIDI DERIVATI SPECIALITA Castelmassa IT (1)

10 CARTINO GELATIN COMPANY LIMITED Muang Samut Prakarn TH (1)

11 CNSG ANHUI HONG SIFANG CO., LTD. Hefei City CN (1)

12 CRODA EUROPE LIMITED Leek GB (1)

13 Chemtura Corporation Middlebury US (4)

14 DISHMAN NETHERLANDS B.V. Veenendaal NL (1)

15 Delft Gelatin BV Delft NL (1)

16 EMERY OLEOCHEMICALS CANADA LTD. Toronto CA (2)

17 EMERY OLEOCHEMICALS LLC Cincinnati US (1)

18 GANSU AMINBIO HALAL GELATIN CO., LTD. Lanzhou City CN (1)

19 GELCO GELATINAS DO BRASIL LTDA Pedreira BR (1)

20 GELITA AG Eberbach DE (3)

21 GELITA Group Eberbach DE (7)

22 GELNEX INDUSTRIA E COMERCIO LTDA Nazario BR (1)

23 GELTECH CO., LTD. Busan KR (1)

24 HALAVET GIDA SANAYI VE TICARET A.Ş. Istanbul TR (2)

25 HUANGSHAN BONSUN PHARMACEUTICALS CO., LTD. Shexian CN (1)

26 INTERNATIONAL FLAVORS & FRAGANCES INC. New York US (1)

27 IOI OLEO GMBH Witten DE (1)

28 International Specialty Products Wayne US (1)

29 JH NANHANG LIFE SCIENCES CO., LTD. Quzhou CN (1)

30 JIAOZUO ZHONGWEI SPECIAL PRODUCTS PHARMACEUTICAL CO., LTD. Jiaozuo CN (2)

31 JRS Pharma GmbH & Co. KG. Rosenberg DE (3)

32 Jellice Co., Ltd. Tagajo JP (1)

33 KLK EMMERICH GMBH Emmerich DE (1)

34 KOLB DISTRIBUTION LTD. Hedingen CH (1)

35 LOTTE FINE CHEMICAL CO., LTD. Incheon KR (2)

36 Lapi Gelatine SpA Empoli (Fi) IT (1)

37 Leiner Pak Gelatine Ltd Lahore PK (1)

38 M/S India Gelatine and Chemicals Ltd Mumbai IN (1)

39 M/S Narmada Gelatines Limited Jabalpur, M.P. IN (1)

40 Mallinckrodt Inc St Louis US (1)

41 Mingtai Chemical Co., Ltd. Taoyuan Hsien TW (1)

42 NEOCHIM S.A. Feluy BE (1)

43 NITTA GELATIN INDIA LTD. Cochin IN (3)

44 NTP GELATINE PRIVATE LIMITED Muridke PK (2)

45 Nippi Incorporated Shizuoka JP (1)

46 Nitta Gelatin Inc. Naniwa-Ku JP (9)

47 OLEOCHIMICA ITALIA S.R.L. Calderara Di Reno IT (1)

48 Oleon NV Ertvelde BE (1)

49 PB Gelatins Vilvoorde BE (4)

50 PB Leiner USA Davenport US (1)

51 PIONEER JELLICE INDIA PRIVATE LIMITED Cuddalore IN (1)

52 PMC BIOGENIX, INC. Memphis US (2)

53 QINGHAI GELATIN COMPANY LIMITED Xining CN (1)

54 RAMA INDUSTRIES LTD. Mumbai IN (1)

55 RANQ REMEDIES PVT. LTD. Kurkumbh IN (1)

56 ROUSSELOT Son NL (13)

57 Raymon Patel Gelatine PVT. Ltd. Mumbai IN (1)

58 Roquette Frères Lestrem FR (6)

59 S.P. QUIMICA, S.A. Riudoms ES (1)

60 SASOL GERMANY GMBH Marl DE (1)

61 SEPPIC S.A. Paris Cedex 07 FR (1)

62 SHANDONG HENGXIN BIOTECH CO., LTD. Binzhou City CN (1)

63 SICHUAN RAYBO BIOTECHNOLOGY CO., LTD. Sanxingdui Town CN (2)

64 SIGACHI INDUSTRIES LIMITED Hyderabad IN (1)

65 SO.G.I.S Industria Chimica SpA Sospiro IT (2)

66 SONAC VUREN B.V. Vuren NL (1)

67 STAR-TECH & JRS SPECIALTY PRODUCTS CO., LTD. Chongqing CN (2)

68 STERLING BIOTECH LIMITED Vadodara IN (1)

69 SYN-TECH CHEM. & PHARM. CO., LTD. Tainan City TW (1)

70 Spiga Nord S.p.A. Genova IT (2)

71 TESSENDERLO GROUP N.V. Vilvoorde BE (1)

72 THE DOW CHEMICAL COMPANY Michigan US (1)

73 THE DOW CHEMICAL COMPANY Midland US (2)

74 UNION DERIVAN, S.A. Barcelona ES (2)

75 Uniqema GmbH & Co. KG Emmerich DE (1)

76 Uniqema Gouda NL (1)

77 VANTAGE OLEOCHEMICALS, INC. Chicago US (1)

78 Weishardt Holding Graulhet FR (1)

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01 Betadex (1)

02 Cellulose, microcrystalline (4)

03 Copovidone, K-value: 25.2-30.8 (1)

04 Crospovidone (1)

05 Crospovidone, Type A and B (6)

06 Gelatin (3)

07 Gelatin, Acid Bone Gelatin (1)

08 Gelatin, Acid Hide Gelatin (1)

09 Gelatin, Acid Hide gelatin (1)

10 Gelatin, Acid bone gelatin (5)

11 Gelatin, Acid hide gelatin (1)

12 Gelatin, Alkaline Hide Gelatin (2)

13 Gelatin, Alkaline hide gelatin (2)

14 Gelatin, Alkaline hide process (2)

15 Gelatin, Alkaline pretreated acid hide gelatin (1)

16 Gelatin, Heat / pressure process - Gel strength - 70 Bloom (1)

17 Gelatin, Limed Bone Gelatin (11)

18 Gelatin, Limed Hide Gelatin (GLF/s) (1)

19 Gelatin, Limed Hide Gelatin - Sodium Hydroxide Hide Gelatin - Lime + Soda Hide Gelatin (1)

20 Gelatin, Limed bone gelatin (25)

21 Gelatin, Limed bone gelatin (Chinese origin) (1)

22 Gelatin, Limed bone gelatin (European origin) (1)

23 Gelatin, Limed bone gelatin - Very short limed bone gelatin (1)

24 Gelatin, Limed bone gelatin India, Argentina, New Zealand and Australia origin (1)

25 Gelatin, Limed hide gelatin (European origin) (2)

26 Gelatin, Limed hide gelatin (Third countries origin) (1)

27 Gelatin, Partial alkaline hydrolysis (Type B) (1)

28 Gelatin, Partial alkaline hydrolysis (Type B), bloom values: 80 g, 90 g, 100 g, 120 g, 150 g, 170 g, 190 g, 220 g, 250 g (1)

29 Gelatin, Partial alkaline hydrolysis (type B) (1)

30 Gelatin, Type A Porkskin Gelatin (1)

31 Glucose monohydrate, for use in the manufacture of parenteral preparations (1)

32 Glycerine (1)

33 Glycerol (6)

34 Glycerol formal (1)

35 Glycerol, (EMERY® 905 glycerine, EMERY® 912 glycerine, EMERY® 913 glycerine, EMERY® 914 glycerine and EMERY® 916 glycerine) (1)

36 Glycerol, EMERY® 916 glycerine (1)

37 Glycerol, Kemstrene ® (1)

38 Glycerol, Product code: 1132200 (1)

39 Glycerol, Vegetable origin (1)

40 Hypromellose (1)

41 Hypromellose phthalate (1)

42 Hypromellose, 2208, 2906, 2910 (1)

43 Hypromellose, E50, 2910, 50 mPa.s (1)

44 Macrogol 15 hydroxystearate (1)

45 Macrogols, Type 3350 and 4000 (1)

46 Macrogols, Type 4000 (1)

47 Macrogols, Types 3350 and 4000 (1)

48 Mannitol (1)

49 Mannitol, For use in the manufacture of parenteral preparations (1)

50 Mannitol, Spray dried (1)

51 Methylcellulose (1)

52 Polysorbate 80 (2)

53 Polysorbate 80, Montanox 80 DF RPR D Montanox 80 DF PPI (1)

54 Povidone, 'Nominal K-value 12' and 'nominal K-value 17' (1)

55 Povidone, 'Nominal K-value 25' and 'nominal K-value 30' (1)

56 Povidone, 'Nominal K-value 90' (1)

57 Povidone, K-12, K-17, K-25, K-30 and K-90 (1)

58 Povidone, K15, K30, K90 (1)

59 Povidone, K25 (1)

60 Povidone, K25, K30 (1)

61 Povidone, K30 (1)

62 Povidone, K90 (1)

63 Sodium alginate (2)

64 Sodium stearyl fumarate (2)

65 Sorbitol (1)

66 Sorbitol, liquid (crystallising) (1)

67 Stearic acid (3)

68 Stearic acid, (Gouda and Emmerich Plants) (1)

69 Stearic acid, Chicago Plant (1)

70 Stearic acid, Code number 2216 (1)

71 Stearic acid, Dervacid 3157 and 3158 (1)

72 Stearic acid, Emersol® 6320, 6332 and 6349 (1)

73 Stearic acid, Hystrene® 5016 (1)

74 Stearic acid, Hystrene® 7018 (1)

75 Stearic acid, Hystrene® 9718 (1)

76 Stearic acid, Industrene® 7018 (1)

77 Stearic acid, Industrene® 8718 (1)

78 Triglycerides, medium-chain (2)

79 Wool Alcohols, Dusoran MD, Dusoran P (1)

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01 Belgium (6)

02 Brazil (1)

03 China (20)

04 France (8)

05 Germany (18)

06 India (13)

07 Italy (9)

08 Japan (12)

09 Netherlands (16)

10 Pakistan (3)

11 South Korea (3)

12 Spain (4)

13 Switzerland (1)

14 Taiwan (1)

15 Thailand (1)

16 Turkey (2)

17 U.S.A (23)

18 United Kingdom (1)

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01 Expired (5)

02 Valid (128)

03 Withdrawn by Holder (9)

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R1-CEP 2004-247 - Rev 00
Valid
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2010-05-05
330
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R1-CEP 2000-067 - Rev 03
Valid
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2012-04-10
330
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R1-CEP 2000-028 - Rev 02
Valid
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2012-04-12
330
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R1-CEP 2000-044 - Rev 04
Valid
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2012-04-12
330
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