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 123 |
| 2. Name or corporate name of registrant | DALES PHARMACEUTICALS LIMITED |
| 3. Permanent or legal address of registrant | DALES PHARMACEUTICALS LIMITED, SNAYGILL INDUSTRIAL ESTATE, KEIGHLEY ROAD, SKIPTON, BD23 2RW, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
DALES PHARMACEUTICALS LIMITED, SNAYGILL INDUSTRIAL ESTATE, KEIGHLEY ROAD, SKIPTON, BD23 2RW, 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 | 05/02/2014 |
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
DALES PHARMACEUTICALS LIMITED, SNAYGILL INDUSTRIAL ESTATE, KEIGHLEY ROAD, SKIPTON, BD23 2RW, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| MEFENAMIC ACID (1000000109) | DONGBANG FUTURE TECHNIQUE & LIFE CO.LTD, 904-5 SANGSIN-RI, HYANGNAM-MYUN, HWASUNG-CITY, KYUNGKI-DO, Data Not Available, SOUTH KOREA YUNG ZIP CHEMICAL INDUSTRY COMPANY LIMITED, 59 YU SHIH ROAD, YOUTH INDUSTRIAL DISTRICT, TACHIA, TW-43767, TAIWAN |
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| DEXAMPHETAMINE SULPHATE (2000007842) | CAMBREX CHARLES CITY INCORPORATED, 1205 ELEVENTH STREET, CHARLES CITY, 50616, UNITED STATES |
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| SODIUM FEREDETATE (4000007079) | SAI ADVANTIUM PHARMA LIMITED , UNIT IV PLOT NO 80-A, 80-B, 81-A & 82, KOLHARE INDUSTRIAL AREA, BIDAR, KARNATAKA, IN-585403, INDIA |
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| MIDAZOLAM (1000000928) | LAKE CHEMICALS PRIVATE LIMITED, 5TH FLOOR LAKSHMI NARAYAN COMPLEX, 10/1 PALACE ROAD, BENGALURU, KARNATAKA, IN-560052, INDIA CHEMAGIS LIMITED, PO BOX 3593, RAMAT HOVAV INDUSTRIAL AREA, BEER SHEVA, IL-84135, ISRAEL |
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| TEMAZEPAM (1000009363) | CENTAUR PHARMACEUTICALS PRIVATE LIMITED, CENTAUR HOUSE, NEAR GRAND HYATT, SHANTI NAGAR, VAKOLA, SANTACRUZ, MUMBAI, IN-400055, INDIA |
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| INOSITOL (1000008613) | TSUNO RICE FINE CHEMICALS COMPANY LIMITED , 2283 CHONOMACHI, KATSURAGI-CHO, ITO-GUN, WAKAYAMA, JP-649 7149, JAPAN |
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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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| ACETOMENAPHTHONE (2000014020) | MIDORI KAGAKU CO LIMITED, 2-27-8 MINAMI IKEBUKURO, TOSHIMA-KU, TOKYO, JP-171-0022, JAPAN |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| TRILOSTANE MICRONISED (3000017510) | |||