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 20782 |
| 2. Name or corporate name of registrant | ALMAC PHARMA SERVICES LIMITED |
| 3. Permanent or legal address of registrant | ALMAC PHARMA SERVICES LIMITED, ALMAC HOUSE, 20 SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, NORTHERN IRELAND, BT63 5QD, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
ALMAC PHARMA SERVICES LIMITED, SEAGOE INDUSTRIAL ESTATE, PORTADOWN, CRAIGAVON, NORTHERN IRELAND, BT63 5UA, 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 | 18/10/2024 |
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
ALMAC PHARMA SERVICES LIMITED, SEAGOE INDUSTRIAL ESTATE, PORTADOWN, CRAIGAVON, NORTHERN IRELAND, BT63 5UA, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| LINACLOTIDE (1000017589) | CORDEN PHARMA COLORADO, 2075 NORTH 55TH STREET, BOULDER, 80301, UNITED STATES POLYPEPTIDE LABORATORIES INC., 365 MAPLE AVENUE, TORRANCE, 90503, UNITED STATES |
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| FIDAXOMICIN (3000016807) | BIOCON LIMITED, BIOCON SPECIAL ECONOMIC ZONE, PLOT NO. 2, 3 & 4, PHASE IV, BOMMASANDRA-JIGANI LINK ROAD, BOMMASANDRA POST, BANGALORE, IN-560099, INDIA |
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| OMADACYCLINE TOSYLATE (2000019343) | CARBOGEN AMCIS AG, HAUPTSTRASSE 171, BUBENDORF, CH-4416, SWITZERLAND |
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| FEDRATINIB (1000019056) | CHANGZHOU SYNTHEALL PHARMACEUTICAL CO., LIMITED, NO. 589 NORTH YULONG ROAD, XINBEI DISTRICT, CHANGZHOU, CN-213127, CHINA |
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| SAPROPTERIN DIHYDROCHLORIDE (4000008948) | DOTTIKON EXCLUSIVE SYNTHESIS AG, HEMBRUNNSTRASSE 17, DOTTIKON, CH-5605, SWITZERLAND |
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| SODIUM HYDROGEN CARBONATE (3000010012) | AVANTOR PERFORMANCE MATERIALS, 7001 MARTIN LUTHER KING BOULEVARD, PARIS, 40361, UNITED STATES |
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| MIGALASTAT HYDROCHLORIDE (2000009471) | CARBOGEN AMCIS AG, HAUPTSTRASSE 171, BUBENDORF, CH-4416, SWITZERLAND |
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| MIGLUSTAT (1000000278) | LONZA AG, LONZASTRASSE, VISP, CH-3930, SWITZERLAND |
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| MACROGOL 3350 (2000012179) | THE DOW CHEMICAL COMPANY, ST CHARLES OPERATIONS, LOUISIANA HIGHWAY 3142, HAHNVILLE, 70057, UNITED STATES |
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| SODIUM CHLORIDE (1000009536) | AVANTOR PERFORMANCE MATERIALS, 7001 MARTIN LUTHER KING BOULEVARD, PARIS, 40361, UNITED STATES |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| FROVATRIPTAN SUCCINATE (2000006383) | |||