Medicines and Healthcare products Regulatory Agency
REGISTRATION OF MANUFACTURER, IMPORTER OR DISTRIBUTOR OF ACTIVE SUBSTANCES TO BE USED AS STARTING MATERIALS IN MEDICINAL PRODUCTS FOR HUMAN USE
| 1. Registration Number | UK API 15343 |
| 2. Name or corporate name of registrant | MALLINCKRODT CHEMICAL LIMITED |
| 3. Permanent or legal address of registrant | MALLINCKRODT CHEMICAL LIMITED, PERTH HOUSE, MILLENNIUM WAY, CHESTERFIELD, S41 8ND, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
MALLINCKRODT CHEMICAL LIMITED , PERTH HOUSE, MILLENNIUM WAY, CHESTERFIELD, S41 8ND, UNITED KINGDOM EXPEDITORS INTERNATIONAL (UK) LIMITED, UNIT 2, 62 MOSLEY ROAD, TRAFFORD PARK, MANCHESTER, M17 1NB, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
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| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 13/03/2024 |
This registration form is valid only when presented with all pages. The authenticity of this registration form may be verified in MHRA-GMDP.
The registration holder referred to in section 2 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in this registration form. Any changes that may have an impact on the quality or safety of the listed active substances must be notified immediately.
SCOPE OF REGISTRATION
MALLINCKRODT CHEMICAL LIMITED , PERTH HOUSE, MILLENNIUM WAY, CHESTERFIELD, S41 8ND, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| NALOXONE (1000000209) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| CODEINE PHOSPHATE (2000007940) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| COCAINE HYDROCHLORIDE (2000007943) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| BUPRENORPHINE (1000007171) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| FENTANYL (1000002290) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| PARACETAMOL (1000009609) | SPECGX LLC, RALEIGH PHARMACEUTICAL PLANT, 8801 CAPITAL BOULEVARD, RALEIGH, 27616, UNITED STATES |
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| METHYLPHENIDATE HYDROCHLORIDE (2000008305) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| ACETAMINOPHEN (3000006363) | SPECGX LLC, RALEIGH PHARMACEUTICAL PLANT, 8801 CAPITAL BOULEVARD, RALEIGH, 27616, UNITED STATES |
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| DIPHENOXYLATE HYDROCHLORIDE (2000007757) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| METHADONE (1000000638) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| FENTANYL CITRATE (2000007584) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| OXYMORPHONE (1000016087) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| NOSCAPINE (1000009663) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| NALTREXONE HYDROCHLORIDE (2000007614) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| SUFENTANIL CITRATE (2000006818) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| DEXTROAMPHETAMINE SULPHATE (2000009340) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| DEXTROAMPHETAMINE (3000005676) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| NALOXONE HYDROCHLORIDE (2000008238) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| METHYLPHENIDATE (1000009492) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| BUPRENORPHINE HYDROCHLORIDE (2000008277) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| NOSCAPINE HYDROCHLORIDE (2000008165) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| HYDROCODONE BITARTRATE (4000009774) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| OXYMORPHONE HYDROCHLORIDE (2000014978) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| METHADONE HYDROCHLORIDE (2000008337) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| NALMEFENE HYDROCHLORIDE (2000007444) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| MORPHINE SULPHATE (2000008246) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| NALBUPHINE HYDROCHLORIDE (2000008240) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| OXYCODONE HYDROCHLORIDE (2000006722) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| SUFENTANIL (1000008500) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| METHYLNALTREXONE BROMIDE (2000010193) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| NALTREXONE BASE ANHYDROUS (3000013154) | SPECGX LLC, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| PARACETAMOL (1000009609) | |||
| ACETAMINOPHEN (3000006363) | |||
EXPEDITORS INTERNATIONAL (UK) LIMITED, UNIT 2, 62 MOSLEY ROAD, TRAFFORD PARK, MANCHESTER, M17 1NB, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| PARACETAMOL COMPRESSIBLE 90% - COMPAP (2000014123) | |||
| PARACETAMOL (1000009609) | |||
| ACETAMINOPHEN (3000006363) | |||
| MAGNESIUM STEARATE - SODIUM LAURYL SULPHATE MIXTURE (1000004991) | |||
| IBUPROFEN (1000008918) | |||