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

Registrant Details
1. Registration NumberUK API 20416
2. Name or corporate name of registrantCRESCENT PHARMA LIMITED
3. Permanent or legal address of registrant CRESCENT PHARMA LIMITED, KEY HOUSE, SARUM HILL, BASINGSTOKE, RG21 8SR, UNITED KINGDOM
4. Address(es) of site(s) where registered activities take place

CRESCENT PHARMA LIMITED, CRESCENT HOUSE, CUNARD ROAD, LONDON, NW10 6PN, UNITED KINGDOM

5. National legal basis of registration
6. Name of responsible officer of the competent authority of the member state validating the registration Confidential
7. Date 18/07/2025

 

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

Name and address of the site

CRESCENT PHARMA LIMITED, CRESCENT HOUSE, CUNARD ROAD, LONDON, NW10 6PN, UNITED KINGDOM

2. IMPORTATION AND DISTRIBUTION OPERATIONS
AImportation
Active Substance 3rd Country Manufacturer 3rd Country Distributor
CARBOCISTEINE (1000006667)

PHARMAZELL GMBH, ROSENHEIMER STRASSE 43, RAUBLING, D-83064, GERMANY

PHARMAZELL GMBH, ROSENHEIMER STRASSE 43, RAUBLING, D-83064, GERMANY

AMANTADINE HYDROCHLORIDE (2000008533)

MOEHS IBRICA S.L., C/O MOEHS IBERICA SL, POLIGONO INDUSTRIAL CAN JARDI, RUBI (BARCELONA), E-08191, SPAIN

MOEHS IBRICA S.L., C/O MOEHS IBERICA SL, POLIGONO INDUSTRIAL CAN JARDI, RUBI (BARCELONA), E-08191, SPAIN

MEBEVERINE HYDROCHLORIDE (2000008414)

COHANCE LIFESCIENCES ? HYDERABAD KNOWLEDGE CITY, C/O COHANCE LIFE SCIENCES LIMITED, 202, 2ND FLOOR, B-WING, GALAXY BY AUROBINDO REALTY, SURVEY NO 83/1, HYDERABAD KNOWLEDGE CITY, TSIIC RAIDURG, PANMAKTHA, HITECH CITY ROAD, HYDERABAD, IN-500081, INDIA

COHANCE LIFESCIENCES ? HYDERABAD KNOWLEDGE CITY, C/O COHANCE LIFE SCIENCES LIMITED, 202, 2ND FLOOR, B-WING, GALAXY BY AUROBINDO REALTY, SURVEY NO 83/1, HYDERABAD KNOWLEDGE CITY, TSIIC RAIDURG, PANMAKTHA, HITECH CITY ROAD, HYDERABAD, IN-500081, INDIA

SODIUM ALGINATE (2000011136)

IFF N&H NORWAY AS, STEINHAUGVEGEN 1, VORMEDAL, NO-5545, NORWAY

IFF N&H NORWAY AS, STEINHAUGVEGEN 1, VORMEDAL, NO-5545, NORWAY

LACTULOSE SOLUTION (2000008519)

BIOFAC A/S COPENHAGEN DENMARK, ENGLANDSVEJ 350-356, KASTRUP, DK-2770, DENMARK

TRIFLUOPERAZINE HYDROCHLORIDE (2000008581)

TRIFARMA S.P.A., VIA GUIDO GUARINI MATTEUCCI, 1, MILAN, I-20162, ITALY

TRIFARMA S.P.A., VIA GUIDO GUARINI MATTEUCCI, 1, MILAN, I-20162, ITALY

SODIUM ALENDRONATE TRIHYDRATE (4000015069)

CADILA PHARMACEUTICALS LIMITED, PLOT NO. 294, GIDC INDUSTRIAL ESTATE, BHARUCH DISTRICT, ANKLESHWAR, GUJARAT, IN-393002, INDIA

CADILA PHARMACEUTICALS LIMITED, PLOT NO. 294, GIDC INDUSTRIAL ESTATE, BHARUCH DISTRICT, ANKLESHWAR, GUJARAT, IN-393002, INDIA

RANITIDINE (1000009740)

ORCHEV PHARMA PVT LIMITED, SHAPAR INDUSTRIAL AREA, N.H. 8-B, RAJKOT-GONDAL HIGHWAY, VERAVAL VILLAGE, RAJKOT DISTRICT, GUJARAT, IN 360024, INDIA

CALCIUM CARBONATE (2000008145)

SUDEEP PHARMA LIMITED, 129/1/A, G.I.D.C. ESTATE, NANDESARI, VADODARA, GUJARAT, IN 391340, INDIA

SUDEEP PHARMA LIMITED, 129/1/A, G.I.D.C. ESTATE, NANDESARI, VADODARA, GUJARAT, IN 391340, INDIA

FLUCLOXACILLIN SODIUM POWDER (4000013526)

FRESENIUS KABI IPSUM SRL, VIA SAN LEONARDO, 23, VILLADOSE (RO), I-45010, ITALY

METOCLOPRAMIDE HYDROCHLORIDE (2000008262)

IPCA LABORATORIES LIMITED, PLOT 125, CST NO 328, KANDIVALI INDUSTRIAL ESTATE, KANDIVALI WEST, MUMBAI, MAHARASHTRA, IN-400067, INDIA

IPCA LABORATORIES LIMITED, PLOT 125, CST NO 328, KANDIVALI INDUSTRIAL ESTATE, KANDIVALI WEST, MUMBAI, MAHARASHTRA, IN-400067, INDIA

ONDANSETRON (1000009100)

DR REDDY'S LABORATORIES LIMITED, 8-2-337, ROAD NO. 3, BANJARA HILLS, HYDERABAD, TELANGANA, IN-500034, INDIA

NITROFURANTOIN (1000009675)

FABBRICA ITALIANA SINTETICI S.P.A., C/O FABBRICA ITALIANA SINTETICI SPA, VIA G. FAA DI BRUNO, 4 I, MONTECCHIO MAGGIORE VI, I-36075, ITALY

FABBRICA ITALIANA SINTETICI S.P.A., C/O FABBRICA ITALIANA SINTETICI SPA, VIA G. FAA DI BRUNO, 4 I, MONTECCHIO MAGGIORE VI, I-36075, ITALY

CAFFEINE (1000007507)

SHANDONG XINHUA PHARMA, MODERN PHARMACEUTICAL INTERNATIONAL COOPERATION CENTER, NO.1 LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, CN-255086, CHINA

SHANDONG XINHUA PHARMA, MODERN PHARMACEUTICAL INTERNATIONAL COOPERATION CENTER, NO.1 LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, CN-255086, CHINA

CETRIMIDE (1000006286)

DISHMAN PHARMACEUTICALS & CHEMICALS LIMITED, PLOT NO 1216/11, 1216/24, 25 & 26, PHASE IV, GIDC ESTATE, NARODA, AHMEDABAD, IN-382 330, INDIA

SODIUM BICARBONATE (1000009540)

SOLVAY CHEMICALS INDIA, REGUS OFFICE NUMBER 402C, 414, 439 & 440, LEVEL 4, DYNASTY BUSINESS PARK, A WING, ANDHERI KURLA ROAD, ANDHERI (E), MUMBAI, MAHARASHTRA, IN-400059, INDIA

SOLVAY CHEMICALS INDIA, REGUS OFFICE NUMBER 402C, 414, 439 & 440, LEVEL 4, DYNASTY BUSINESS PARK, A WING, ANDHERI KURLA ROAD, ANDHERI (E), MUMBAI, MAHARASHTRA, IN-400059, INDIA

CHLORPHENAMINE MALEATE (4000007290)

SUPRIYA LIFE SCIENCE LIMITED, A-5/2 LOTE PARSHURAM INDUSTRIAL AREA, MIDC, TALUKA KHED, RATNAGIRI, MAHARASHTRA, IN-415 722, INDIA

HYOSCINE BUTYLBROMIDE (2000007324)

ALCHEM INTERNATIONAL PRIVATE LIMITED, PLOT NO 25/2, MATHURA ROAD, VILLAGE KALLI, BALLABGARH, FARIDABAD, HARYANA, IN-121004, INDIA

ALCHEM INTERNATIONAL PRIVATE LIMITED, PLOT NO 25/2, MATHURA ROAD, VILLAGE KALLI, BALLABGARH, FARIDABAD, HARYANA, IN-121004, INDIA

OXYBUTYNIN HYDROCHLORIDE (2000008318)

HARMAN FINOCHEM LIMITED, 107-A, VINAY BHAVYA COMPLEX, 159-A, CST ROAD, KALINA, SANTA CRUZ (EAST), MUMBAI, MAHARASHTRA, IN-400098, INDIA

HARMAN FINOCHEM LIMITED, 107-A, VINAY BHAVYA COMPLEX, 159-A, CST ROAD, KALINA, SANTA CRUZ (EAST), MUMBAI, MAHARASHTRA, IN-400098, INDIA

CETIRIZINE DIHYDROCHLORIDE (4000006373)

GLOCHEM INDUSTRIES LIMITED, SANATH NAGAR UNIT, GV CHAMBERS, 7-2-C8 & C8/2, IDA SANATHNAGAR, HYDERABAD, IN-500 018, INDIA

GLOCHEM INDUSTRIES LIMITED, SANATH NAGAR UNIT, GV CHAMBERS, 7-2-C8 & C8/2, IDA SANATHNAGAR, HYDERABAD, IN-500 018, INDIA

PARACETAMOL (1000009609)

SRI KRISHNA PHARMACEUTICALS LIMITED, UNIT 1, C-4, INDUSTRIAL DEVELOPMENT AREA, UPPAL, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD, TELANGANA, IN-500039, INDIA

SODIUM PICOSULFATE (3000010007)

KREATIVE, D-123, PHASE III, IDA, JEEDIMETLA VILLAGE, QUTHBULLAPUR MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD, TELANGANA, IN-500055, INDIA

DESLORATADINE (1000000735)

ALIVUS LIFESCIENCES ? NAVI MUMBAI FACILITY, C/O ALVIUS LIFE SCIENCES, PLOT NO A-607, TTC INDUSTRIAL AREA, MIDC, MAHAPE, NAVI MUMBAI, THANE, IN-400709, INDIA

ALIVUS LIFESCIENCES ? NAVI MUMBAI FACILITY, C/O ALVIUS LIFE SCIENCES, PLOT NO A-607, TTC INDUSTRIAL AREA, MIDC, MAHAPE, NAVI MUMBAI, THANE, IN-400709, INDIA

GLYCOPYRRONIUM BROMIDE (2000011773)

PCAS, 21 CHEMIN DE LA SAUVEGARDE, CS 33167, ECULLY CEDEX, FR-69130, FRANCE

PCAS, 21 CHEMIN DE LA SAUVEGARDE, CS 33167, ECULLY CEDEX, FR-69130, FRANCE

KETOCONAZOLE (1000008441)

PIRAMAL PHARMA LIMITED, C/O PIRAMAL PHARMA LIMITED, SURVEY NO. 7-70, 70/1, AND 70/2, DIGWAL VILLAGE, KOHIR MANDAL, DIGWAL, SANGAREDDYDISTRICT, IN-502321, INDIA

PIRAMAL PHARMA LIMITED, C/O PIRAMAL PHARMA LIMITED, SURVEY NO. 7-70, 70/1, AND 70/2, DIGWAL VILLAGE, KOHIR MANDAL, DIGWAL, SANGAREDDYDISTRICT, IN-502321, INDIA

LORATADINE (1000009103)

VASUDHA PHARMA CHEM LIMITED, UNIT I, PLOT NO. 37/A, 38, 39 A & B , PHASE I, INDUSTRIAL DEVELOPMENT AREA, JEEDIMETLA, HYDERABAD, TELANGANA, IN 500055, INDIA

VASUDHA PHARMA CHEM LIMITED, UNIT I, PLOT NO. 37/A, 38, 39 A & B , PHASE I, INDUSTRIAL DEVELOPMENT AREA, JEEDIMETLA, HYDERABAD, TELANGANA, IN 500055, INDIA

DICYCLOVERINE HYDROCHLORIDE (4000007015)

INDOCO REMEDIES LIMITED, INDOCO HOUSE, 166 CST ROAD, SANTACRUZ (EAST), MUMBAI, IN-400098, INDIA

INDOCO REMEDIES LIMITED, INDOCO HOUSE, 166 CST ROAD, SANTACRUZ (EAST), MUMBAI, IN-400098, INDIA

MELATONIN (1000000731)

SWATI SPENTOSE PRIVATE LIMITED, C/O SWATI SPENTOSE PRIVATE LIMITED, PLOT NO. 15, CAMA INDUSTRIAL ESTATE, MUMBAI, MAHARASHTRA, IN-400063, INDIA

SWATI SPENTOSE PRIVATE LIMITED, C/O SWATI SPENTOSE PRIVATE LIMITED, PLOT NO. 15, CAMA INDUSTRIAL ESTATE, MUMBAI, MAHARASHTRA, IN-400063, INDIA

ALIMEMAZINE HEMITARTRATE (2000021146)

PCAS, 21 CHEMIN DE LA SAUVEGARDE, CS 33167, ECULLY CEDEX, FR-69130, FRANCE

PCAS, 21 CHEMIN DE LA SAUVEGARDE, CS 33167, ECULLY CEDEX, FR-69130, FRANCE

CHLORHEXIDINE DIGLUCONATE 20% (4000015437)

BAJAJ HEALTHCARE LIMITED., PLOT NO. B-39, B-39/A, B-39 A/1, 602-606, BHOOMI VELOCITY INFOTECH PARK, ROAD NO. 23, WAGLE INDUSTRIAL ESTATE, THANE WEST, MAHARASHTRA, IN-400604, INDIA

BAJAJ HEALTHCARE LIMITED., PLOT NO. B-39, B-39/A, B-39 A/1, 602-606, BHOOMI VELOCITY INFOTECH PARK, ROAD NO. 23, WAGLE INDUSTRIAL ESTATE, THANE WEST, MAHARASHTRA, IN-400604, INDIA

SENNOSIDES (2000013014)

SHASHI PHYTOCHEMICAL INDUSTRIES, 1 OLD INDUSTRIAL AREA, ALWAR, IN-301001, INDIA

SHASHI PHYTOCHEMICAL INDUSTRIES, 1 OLD INDUSTRIAL AREA, ALWAR, IN-301001, INDIA

PROPRANOLOL HYDROCHLORIDE (2000007892)

IPCA LABORATORIES LIMITED, PLOT 125, CST NO 328, KANDIVALI INDUSTRIAL ESTATE, KANDIVALI WEST, MUMBAI, MAHARASHTRA, IN-400067, INDIA

IPCA LABORATORIES LIMITED, PLOT 125, CST NO 328, KANDIVALI INDUSTRIAL ESTATE, KANDIVALI WEST, MUMBAI, MAHARASHTRA, IN-400067, INDIA

AMITRIPTYLINE HYDROCHLORIDE (2000008522)

VASUDHA PHARMA CHEM LIMITED, UNIT I, PLOT NO. 37/A, 38, 39 A & B , PHASE I, INDUSTRIAL DEVELOPMENT AREA, JEEDIMETLA, HYDERABAD, TELANGANA, IN 500055, INDIA

VASUDHA PHARMA CHEM LIMITED, UNIT I, PLOT NO. 37/A, 38, 39 A & B , PHASE I, INDUSTRIAL DEVELOPMENT AREA, JEEDIMETLA, HYDERABAD, TELANGANA, IN 500055, INDIA

LEVETIRACETAM (1000013222)

ZHEJIANG HUAHAI PHARMACEUTICAL CO LIMITED, XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA

PHENOXYMETHYLPENICILLIN POTASSIUM (2000008070)

BIOTIKA A.S., PO BOX 976 13, SLOVENSKA L'UPCA, SK-566, SLOVAKIA

PROMAZINE HYDROCHLORIDE (2000007897)

PCAS, 21 CHEMIN DE LA SAUVEGARDE, CS 33167, ECULLY CEDEX, FR-69130, FRANCE

PCAS, 21 CHEMIN DE LA SAUVEGARDE, CS 33167, ECULLY CEDEX, FR-69130, FRANCE

TRIMETHOPRIM (1000009283)

IPCA LABORATORIES LIMITED, 48 KANDIVLI INDUSTRIAL ESTATE, KANDIVLI (WEST), MUMBAI, IN-400 067, INDIA

ACETYLSALICYLIC ACID (3000006351)

SHANDONG XINHUA PHARMA, MODERN PHARMACEUTICAL INTERNATIONAL COOPERATION CENTER, NO.1 LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, CN-255086, CHINA

SHANDONG XINHUA PHARMA, MODERN PHARMACEUTICAL INTERNATIONAL COOPERATION CENTER, NO.1 LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, CN-255086, CHINA

FLUOXETINE HYDROCHLORIDE (2000008390)

CADILA PHARMACEUTICALS LIMITED, PLOT NO. 294, GIDC INDUSTRIAL ESTATE, BHARUCH DISTRICT, ANKLESHWAR, GUJARAT, IN-393002, INDIA

CADILA PHARMACEUTICALS LIMITED, PLOT NO. 294, GIDC INDUSTRIAL ESTATE, BHARUCH DISTRICT, ANKLESHWAR, GUJARAT, IN-393002, INDIA

CARGLUMIC ACID (1000000807)

NURAY CHEMICALS PVT. LIMITED., GROUND FLOOR, PLOT NUMBER 111, SIDCO INDUSTRIAL ESTATE, KAKKALUR, THIRUVALLUR, TAMIL NADU, IN-602003, INDIA

NURAY CHEMICALS PVT. LIMITED., GROUND FLOOR, PLOT NUMBER 111, SIDCO INDUSTRIAL ESTATE, KAKKALUR, THIRUVALLUR, TAMIL NADU, IN-602003, INDIA

IBUPROFEN (1000008918)

SOLARA ACTIVE PHARMA SCIENCES LIMITED, MATHUR ROAD, PERIYAKALAPET, PUDUCHERRY, IN-605014, INDIA

NYSTATIN (1000009661)

ROZTOKY FACILITY, VLTAVSKA 53, ROZTOKY, CZ-252 63, CZECHIA

ROZTOKY FACILITY, VLTAVSKA 53, ROZTOKY, CZ-252 63, CZECHIA

METFORMIN HYDROCHLORIDE (2000008338)

USV PRIVATE LIMITED, ARVND VITHAL GANDHI CHOWK, BSD MARG, STATION ROAD, GOVANDI EAST, MUMBAI, MAHARASHTRA, IN-400088, INDIA

USV PRIVATE LIMITED, ARVND VITHAL GANDHI CHOWK, BSD MARG, STATION ROAD, GOVANDI EAST, MUMBAI, MAHARASHTRA, IN-400088, INDIA

FERROUS FUMARATE (2000007579)

DR. PAUL LOHMANN GMBH & CO. KGAA, HAUPTSTRASSE 2, EMMERTHAL, D-31860, GERMANY

DR. PAUL LOHMANN GMBH & CO. KGAA, HAUPTSTRASSE 2, EMMERTHAL, D-31860, GERMANY

DIHYDROCODEINE HYDROGEN TARTRATE (4000008052)

SALARAS S.P.A., C/O SALARAS S.P.A, VIA G. DI VITTORIO, 2, SARONNO VA, I-21047, ITALY

SALARAS S.P.A., C/O SALARAS S.P.A, VIA G. DI VITTORIO, 2, SARONNO VA, I-21047, ITALY

CARBAMAZEPINE (1000006757)

CTX LIFESCIENCES PRIVATE LIMITED, BLOCK NO. 251-252, SACHIN-MAGDALLA ROAD, GIDC, SACHIN, SURAT, GUJARAT, IN-394 230, INDIA

CTX LIFESCIENCES PRIVATE LIMITED, BLOCK NO. 251-252, SACHIN-MAGDALLA ROAD, GIDC, SACHIN, SURAT, GUJARAT, IN-394 230, INDIA

CODEINE PHOSPHATE HEMIHYDRATE (4000006570)

PALLA PHARMA NORWAY AS, GRUVEVEIEN 1, KRAGERO, NO-3770, NORWAY

PALLA PHARMA NORWAY AS, GRUVEVEIEN 1, KRAGERO, NO-3770, NORWAY

AMOXICILLIN TRIHYDRATE (4000006303)

ANTIBIOTICOS SA, AVDA ANTIBIOTICOS 59-61, LEON, 24009, SPAIN

ATENOLOL (1000009849)

IPCA LABORATORIES LIMITED, 48 KANDIVLI INDUSTRIAL ESTATE, KANDIVLI (WEST), MUMBAI, IN-400 067, INDIA

BACLOFEN (1000009324)

PHARMACEUTICAL WORKS POLPHARMA S.A., 19 PELPLINSKA STREET, STAROGARD GDANSKI, PL-83-200, POLAND

2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
CARBOCISTEINE (1000006667)
AMANTADINE HYDROCHLORIDE (2000008533)
MEBEVERINE HYDROCHLORIDE (2000008414)
SODIUM ALGINATE (2000011136)
LACTULOSE SOLUTION (2000008519)
TRIFLUOPERAZINE HYDROCHLORIDE (2000008581)
SODIUM ALENDRONATE TRIHYDRATE (4000015069)
RANITIDINE (1000009740)
CALCIUM CARBONATE (2000008145)
FLUCLOXACILLIN SODIUM POWDER (4000013526)
METOCLOPRAMIDE HYDROCHLORIDE (2000008262)
ONDANSETRON (1000009100)
NITROFURANTOIN (1000009675)
CETRIMIDE (1000006286)
SODIUM BICARBONATE (1000009540)
CHLORPHENAMINE MALEATE (4000007290)
HYOSCINE BUTYLBROMIDE (2000007324)
OXYBUTYNIN HYDROCHLORIDE (2000008318)
CETIRIZINE DIHYDROCHLORIDE (4000006373)
PARACETAMOL (1000009609)
CLOVE OIL (4000010430)
SODIUM PICOSULFATE (3000010007)
DESLORATADINE (1000000735)
GLYCOPYRRONIUM BROMIDE (2000011773)
KETOCONAZOLE (1000008441)
LORATADINE (1000009103)
DICYCLOVERINE HYDROCHLORIDE (4000007015)
MELATONIN (1000000731)
ALIMEMAZINE HEMITARTRATE (2000021146)
CHLORHEXIDINE DIGLUCONATE 20% (4000015437)
SENNOSIDES (2000013014)
PROPRANOLOL HYDROCHLORIDE (2000007892)
AMITRIPTYLINE HYDROCHLORIDE (2000008522)
LEVETIRACETAM (1000013222)
PHENOXYMETHYLPENICILLIN POTASSIUM (2000008070)
PROMAZINE HYDROCHLORIDE (2000007897)
TRIMETHOPRIM (1000009283)
WHITE SOFT PARAFFIN (4000006817)
FLUOXETINE HYDROCHLORIDE (2000008390)
CARGLUMIC ACID (1000000807)
IBUPROFEN (1000008918)
NYSTATIN (1000009661)
LIGHT LIQUID PARAFFIN (4000006491)
METFORMIN HYDROCHLORIDE (2000008338)
LIQUID PARAFFIN (4000006486)
FERROUS FUMARATE (2000007579)
DIHYDROCODEINE HYDROGEN TARTRATE (4000008052)
CARBAMAZEPINE (1000006757)
CODEINE PHOSPHATE HEMIHYDRATE (4000006570)
AMOXICILLIN TRIHYDRATE (4000006303)
ATENOLOL (1000009849)
BACLOFEN (1000009324)