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 43457 |
| 2. Name or corporate name of registrant | SABAL HEALTH AND PHARMA LIMITED |
| 3. Permanent or legal address of registrant | SABAL HEALTH AND PHARMA LIMITED, SPA HOUSE, 69 SOUTHEND ROAD, HOCKLEY, SS5 4PZ, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
SABAL HEALTH AND PHARMA LIMITED, SPA HOUSE, 69 SOUTHEND ROAD, HOCKLEY, SS5 4PZ, 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 | 16/04/2024 |
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
SABAL HEALTH AND PHARMA LIMITED, SPA HOUSE, 69 SOUTHEND ROAD, HOCKLEY, SS5 4PZ, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| TAMOXIFEN CITRATE (2000007386) | EXCELLA GMBH & CO KG, NUERNBERGER STRASSE 12, FEUCHT, D-90537, GERMANY |
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| BACLOFEN (1000009324) | EXCELLA GMBH & CO KG, NUERNBERGER STRASSE 12, FEUCHT, D-90537, GERMANY |
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| DEXTROMETHORPHAN (1000003241) | DIVI'S LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, INDIA |
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| PHENYLEPHRINE (1000009891) | MALLADI DRUGS & PHARMACEUTICALS LIMITED, UNIT 3, 7B AND 7C, SIPCOT INDUSTRIAL COMPLEX, RANIPET, RANIPET, TAMIL NADU, IN-632403, INDIA |
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| GRISEOFULVIN (1000001953) | CHIFENG PHARMACEUTICAL COMPANY LIMITED, 84 YIDONG STREET, CHIFENG, HONGSHAN DISTRICT, INNER MONGOLIA, CN-024 001, CHINA |
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| METHOTREXATE DISODIUM (4000003566) | EXCELLA GMBH & CO KG, NUERNBERGER STRASSE 12, FEUCHT, D-90537, GERMANY |
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| CAFFEINE (1000007507) | SHANDONG XINHUA PHARMACEUTICAL CO LIMITED, 14 DONGYI ROAD, ZHANGDIAN DISTRICT, ZIBO, SHANDONG, CN-255005, CHINA |
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| CODEINE PHOSPHATE (2000007940) | PALLA PHARMA NORWAY AS, GRUVEVEIEN 1, KRAGERO, NO-3770, NORWAY |
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| DILTIAZEM HYDROCHLORIDE (2000007763) | LUSOCHIMICA S.P.A., VIA GIOTTO 9, LOMAGNA LC, I-23871, ITALY |
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| TERBUTALINE SULPHATE (2000007383) | LUSOCHIMICA S.P.A., VIA GIOTTO 9, LOMAGNA LC, I-23871, ITALY |
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| TRAMADOL (1000007320) | CHEMAGIS LIMITED, 3 HASHLOSHA STREET, TEL AVIV, IL-61090, ISRAEL |
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| IBUPROFEN LYSINE (2000011938) | SOLARA ACTIVE PHARMA SCIENCES LIMITED, RS NO. 33 & 34, MATHUR ROAD, PERIYAKALAPET, PUDUCHERRY, IN 605014, INDIA |
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| SALBUTAMOL (1000009712) | LUSOCHIMICA S.P.A., VIA GIOTTO 9, LOMAGNA LC, I-23871, ITALY |
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| IBUPROFEN (1000008918) | SOLARA ACTIVE PHARMA SCIENCES LIMITED, RS NO. 33 & 34, MATHUR ROAD, PERIYAKALAPET, PUDUCHERRY, IN 605014, INDIA |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| TAMOXIFEN CITRATE (2000007386) | |||
| BACLOFEN (1000009324) | |||
| DEXTROMETHORPHAN (1000003241) | |||
| PHENYLEPHRINE (1000009891) | |||
| GRISEOFULVIN (1000001953) | |||
| METHOTREXATE DISODIUM (4000003566) | |||
| CAFFEINE (1000007507) | |||
| CODEINE PHOSPHATE (2000007940) | |||
| DILTIAZEM HYDROCHLORIDE (2000007763) | |||
| TERBUTALINE SULPHATE (2000007383) | |||
| TRAMADOL (1000007320) | |||
| IBUPROFEN LYSINE (2000011938) | |||
| SALBUTAMOL (1000009712) | |||
| IBUPROFEN (1000008918) | |||