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 49594 |
| 2. Name or corporate name of registrant | ACI GROUP LTD |
| 3. Permanent or legal address of registrant | ACI GROUP LTD, MOOR HALL, THE MOOR, COOKHAM, MAIDENHEAD, SL6 9QH, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
MOVIANTO UK LIMITED, UNIT 1, BEDFORD LINK LOGISTICS PARK, BELL FARM WAY, KEMPSTON, BEDFORD, MK43 9SS, UNITED KINGDOM ACI GROUP LTD, MOOR HALL, THE MOOR, COOKHAM, MAIDENHEAD, SL6 9QH, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
|
| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 13/05/2024 |
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
MOVIANTO UK LIMITED, UNIT 1, BEDFORD LINK LOGISTICS PARK, BELL FARM WAY, KEMPSTON, BEDFORD, MK43 9SS, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| AMOBARBITAL SODIUM (4000006304) | |||
| PARACETAMOL (1000009609) | |||
| PSEUDOEPHEDRINE HYDROCHLORIDE (2000007829) | |||
| BENZOCAINE (1000009160) | |||
| DOMIPHEN BROMIDE (2000007748) | |||
| HYDROCORTISONE ACETATE (2000007338) | |||
| SECOBARBITAL SODIUM (4000007161) | |||
ACI GROUP LTD, MOOR HALL, THE MOOR, COOKHAM, MAIDENHEAD, SL6 9QH, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| CHLORPHENIRAMINE MALEATE (2000008095) | SUPRIYA LIFE SCIENCE LMITED, A-5/2 LOTE PARSHURAM INDUSTRIAL AREA, MIDC, TALUKA KHED, RATNAGIRI, MAHARASHTRA, IN-415 722, INDIA |
||
| PSEUDOEPHEDRINE HYDROCHLORIDE (2000007829) | MALLADI DRUGS AND PHARMACEUTICALS LIMITED, UNIT 3, 7B AND 7C, SIPCOT INDUSTRIAL COMPLEX, RANIPET, RANIPET, TAMIL NADU, IN-632403, INDIA |
||
| PARACETAMOL (1000009609) | ANQIU LUAN PHARMACEUTICAL, 35 WEIXU NORTH ROAD, ANQIU CITY, SHANDONG PROVINCE, CN-262 100, CHINA |
||
| BENZOCAINE (1000009160) | CHANGZHOU SUNLIGHT PHARMACEUTICAL CO., LIMITED., 216 YUNNAN WEST ROAD, BENNIU TOWN, XINBEI DISTRICT, CHANGZHOU CITY, JIANGSU PROVINCE, CN 213134, CHINA |
||
| CYCLIZINE HYDROCHLORIDE (2000007923) | SRIKEM LABORATORIES PVT, LIMITED, PLOT NO. 17/42 MIDC, TALOJA, PANVEL, NAVI MUMBAI, MAHARASHTRA, IN-410 208, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| CHLORPHENIRAMINE MALEATE (2000008095) | |||
| HYDROCORTISONE ACETATE (2000007338) | |||
| PSEUDOEPHEDRINE HYDROCHLORIDE (2000007829) | |||
| SECOBARBITAL SODIUM (4000007161) | |||
| QUININE HYDROCHLORIDE (2000007815) | |||
| AMOBARBITAL SODIUM (4000006304) | |||
| CHLORAL HYDRATE (1000005193) | |||
| PARACETAMOL (1000009609) | |||
| BENZOCAINE (1000009160) | |||
| BARBITAL SODIUM (2000008438) | |||
| DOMIPHEN BROMIDE (2000007748) | |||
| QUININE SULPHATE (2000007814) | |||
| GLYCERYL TRINITRATE (1000001637) | |||
| CYCLIZINE HYDROCHLORIDE (2000007923) | |||
| BISMUTH SUBSALICYLATE (2000008291) | |||