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List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Mallinckrodt Pharmaceuticals by EDQM. Original Data: EDQM Database

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01 Buprenorphine (1)

02 Buprenorphine hydrochloride (1)

03 Buprenorphine hydrochloride, Process II (1)

04 Calcium stearate, (Code numbers 2246, 2247, 2241) (1)

05 Codeine phosphate hemihydrate (1)

06 Desmopressin (1)

07 Dexamfetamine sulfate (1)

08 Fentanyl (1)

09 Fentanyl citrate (1)

10 Leuprorelin (1)

11 Magnesium stearate, (Code numbers 2256, 2255) (1)

12 Methylphenidate hydrochloride (1)

13 Methylphenidate hydrochloride, Process II, Non-fine (Code 0570) and Fine (Code 1335) (1)

14 Naloxone hydrochloride dihydrate, Code 1492 (1)

15 Naltrexone hydrochloride (1)

16 Oxycodone hydrochloride (1)

17 Paracetamol (1)

18 Sufentanil (1)

19 Sufentanil citrate (1)

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01 MALLINCKRODT, INC. Hazelwood US (1)

02 Mallinckrodt Inc St Louis US (3)

03 SPECGX LLC Webster Groves US (15)

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01 Ireland (7)

02 U.S.A (12)

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01 Expired (1)

02 Valid (17)

03 Withdrawn by Holder (1)

URL Supplier Web Content
SPECGX LLC Webster Grov...
Valid
R1-CEP 2013-098 - Rev 00
Chemical
2021-06-24
1180
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SPECGX LLC Webster Grov...
Valid
R1-CEP 2013-048 - Rev 00
Chemical
2021-05-04
1181
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SPECGX LLC Webster Grov...
Valid
R0-CEP 2023-107 - Rev 00
Chemical
2023-08-24
1181
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Mallinckrodt Inc St Lou...
Valid
R1-CEP 2000-177 - Rev 01
TSE
2006-11-15
882
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SPECGX LLC Webster Grov...
Valid
R1-CEP 1999-152 - Rev 04
Chemical
2018-10-04
74
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Mallinckrodt Inc St Lou...
Expired
R0-CEP 2000-060 - Rev 01
Chemical
2004-11-22
2008-01-31
712
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SPECGX LLC Webster Grov...
Valid
R0-CEP 2020-076 - Rev 00
Chemical
2021-07-26
2752
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SPECGX LLC Webster Grov...
Valid
CEP 2005-260 - Rev 03
Chemical
2024-02-14
1210
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SPECGX LLC Webster Grov...
Valid
CEP 2009-097 - Rev 02
Chemical
2024-01-30
1103
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MALLINCKRODT, INC. Haze...
Withdrawn by Holder
R1-CEP 2001-323 - Rev 02
Chemical
2012-07-20
2017-10-30
1442
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