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 29595 |
| 2. Name or corporate name of registrant | PIRAMAL HEALTHCARE UK LIMITED |
| 3. Permanent or legal address of registrant | PIRAMAL HEALTHCARE UK LIMITED, WHALTON ROAD, MORPETH, NORTHUMBERLAND, NE61 3YA, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
PIRAMAL HEALTHCARE UK LIMITED , WHALTON ROAD, MORPETH, NORTHUMBERLAND, NE61 3YA, UNITED KINGDOM PIRAMAL HEALTHCARE UK LIMITED, EARLS ROAD, GRANGEMOUTH, FK3 8XG, 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 | 03/05/2024 |
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
PIRAMAL HEALTHCARE UK LIMITED , WHALTON ROAD, MORPETH, NORTHUMBERLAND, NE61 3YA, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Micronisation | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
.HPLC column purification (of misoprostol) | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
.Dispersing of Misoprostol pure with Hypromellose, milling. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
.Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
.Drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation and optional recrystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying, sieving | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
.HPLC column purification | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Milled | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates
Special Requirements Other: Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility and manufacturing controls have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. | |
| A.2 Manufacture of Crude Active Substance
Special Requirements Other: Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility and manufacturing controls have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation Special Requirements Other: Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility and manufacturing controls have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Milling Special Requirements Other: Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility and manufacturing controls have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. | |
| E.2 Primary Packaging
Special Requirements Other: Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility, manufacturing controls and packaging have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. | |
| E.3 Secondary Packaging
Special Requirements Other: Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility, manufacturing controls and packaging have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing
Special Requirements Other: Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility, manufacturing controls, packaging and QC testing facilities have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| BEXAGLIFLOZIN (1000018985) | CARBOGEN AMCIS AG, HAUPTSTRASSE 171, BUBENDORF, CH-4416, SWITZERLAND PIRAMAL DIGWAL, SURVEY NOS. 7-70, 70/1 AND 70/2, DIGWAL VILLAGE, KOHIR MANDAL, KOHIR CROSS ROAD, SANGAREDDY DISTRICT, TELANGANA, IN-502 321, INDIA |
||
| BENZBROMARONE (1000003448) | IPCA LABORATORIES LIMITED, PLOT NOS. 4722, 4723, 4731 AND 4732, GIDC ESTATE, ANKLESHWAR DISTRICT, BHARUCH, IN-393002, INDIA |
||
| EPLERENONE (1000001060) | AURISCO PHARMACEUTICAL CO. LIMITED, BADU INDUSTRIAL PARK ZONE, TIANTAI, ZHEJIANG PROVINCE, CN 317200, CHINA |
||
| WARFARIN SODIUM CLATHRATE (2000006248) | ALEMBIC LIMITED, PLOT NO. 842-843, VILLAGE- KARAKHADI, TALUK- PADRA, VADODARA, GUJARAT, IN-391 450, INDIA APOTEX PHARMACHEM INC, 34-36 SPALDING DRIVE, BRANTFORD ON, N3T 6B8, CANADA |
||
| TETRACYCLINE HYDROCHLORIDE (2000007377) | NINGXIA QIYUAN PHARMACEUTICAL COMPANY LIMITED, NO 1 QIYUAN STEET, WANGYUAN INDUSTRIAL AREA, YINCHUAN, NINGXIA, CN-750101, CHINA |
||
| DICLOFENAC SODIUM (2000007774) | AMOLI ORGANICS PRIVATE LIMITED, PLOT NO 322/4, 40 SHED AREA, GIDC, VAPI, GUJARAT, IN-396 195, INDIA |
||
| NORETHISTERONE (1000009666) | INDUSTRIAS QUIMICAS FALCON DE MEXICO, SA DE CV, KM 4.5 CARRETERA FEDERAL CUERNAVACA-CUAUTLA, JIUTEPEC, MORELOS, 62578, MEXICO |
||
| PREDNISOLONE (1000009794) | TIANJIN TIANYAO PHARMACEUTICALS CO LIMITED, 19 XINYE 9TH STREET, WEST AREA OF TEDA, TIANJIN, CN-300 462, CHINA |
||
| ETHINYLESTRADIOL (3000004575) | INDUSTRIAS QUIMICAS FALCON DE MEXICO, SA DE CV, KM 4.5 CARRETERA FEDERAL CUERNAVACA-CUAUTLA, JIUTEPEC, MORELOS, 62578, MEXICO |
||
| OBETICHOLIC ACID (1000018845) | PHARMACIA AND UPJOHN COMPANY LLC, 7000 PORTAGE ROAD, KALAMAZOO, 49001, UNITED STATES PHARMAZELL SCHWEIZ GMBH, ORISTALSTRASSE 65, LIESTAL, CH-4410, SWITZERLAND |
||
| BEMPEDOIC ACID (1000017714) | CORDEN PHARMA COLORADO INC., 2075 NORTH 55TH STREET, BOULDER, 80301, UNITED STATES NEULAND LABORATORIES LIMITED, UNIT 2, PLOT NO. 92-94 AND 257-259, IDA, PASHAMYLARAM, PASHAMYLARAM VILLAGE, PATANCHERU MANDAL, SANGAREDDY, TELANGANA, IN-502319, INDIA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| SPIRONOLACTONE (1000009436) | |||
| MISOPROSTOL:HYPROMELLOSE 1:100 DISPERSION (4000014458) | |||
| CANRENOATE POTASSIUM (4000007373) | |||
| PARECOXIB SODIUM (2000005830) | |||
| MISOPROSTOL (1000009076) | |||
| FOSTEMSAVIR (1000018194) | |||
PIRAMAL HEALTHCARE UK LIMITED, EARLS ROAD, GRANGEMOUTH, FK3 8XG, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallization step | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying in vacuum oven | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| CLOPROSTENOL SODIUM (2000020722) | |||