Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1Lupin Ltd
03 61Vertex Pharmaceuticals
04 16Vertex Pharmaceuticals (Australia) Pty. Ltd.
01 3Antic-calc Tablet, Film Coated
02 1FILM COATED PILL
03 1Film Coated Tablet
04 6Filmtabl
05 8GRANULE;ORAL
06 11GRANULES
07 2GRANULES IN SACHET
08 2GRANULES;ORAL
09 5Gran
10 2Granules
11 4Granules in a dose bag
12 1Ivacaftor 150Mg 56 Combined Oral Use
13 9TABLET
14 1TABLET; ORAL
15 7TABLET;ORAL
16 4tablet
17 12Blank
01 20Prescription
02 17RX
03 42Blank
01 2Cafe trio
02 1IVACAFTOR
03 11KALYDECO
04 30Kalydeco
05 10ORKAMBI
06 5Orkambi
07 2SYMDEKO
08 2SYMDEKO (COPACKAGED)
09 1Symdeko
10 8TRIKAFTA
11 4TRIKAFTA (COPACKAGED)
12 2Trikafta
13 1Blank
01 16Australia
02 20Canada
03 1Italy
04 9Norway
05 1Spain
06 3Sweden
07 11Switzerland
08 18USA
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : USA
Brand Name : IVACAFTOR
Dosage Form : TABLET; ORAL
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number : 216074
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : TABLET;ORAL
Dosage Strength : 150MG
Packaging :
Approval Date : 2012-01-31
Application Number : 203188
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : TABLET;ORAL
Dosage Strength : 125MG;200MG
Packaging :
Approval Date : 2015-07-02
Application Number : 206038
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : TABLET;ORAL
Dosage Strength : 125MG;100MG
Packaging :
Approval Date : 2016-09-28
Application Number : 206038
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 50MG/PACKET
Packaging :
Approval Date : 2015-03-17
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 75MG/PACKET
Packaging :
Approval Date : 2015-03-17
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 25MG/PACKET
Packaging :
Approval Date : 2019-04-29
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 5.8MG/PACKET
Packaging :
Approval Date : 2023-05-03
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 13.4MG/PACKET
Packaging :
Approval Date : 2023-05-03
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
IVACAFTOR; IVACAFTOR, TEZACAFTOR
Brand Name : SYMDEKO (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 150MG;150MG, 100MG
Packaging :
Approval Date : 2018-02-12
Application Number : 210491
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
IVACAFTOR; IVACAFTOR, TEZACAFTOR
Brand Name : SYMDEKO (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 75MG;75MG, 50MG
Packaging :
Approval Date : 2019-06-21
Application Number : 210491
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : GRANULE;ORAL
Dosage Strength : 125MG/PACKET;100MG/PACKET
Packaging :
Approval Date : 2018-08-07
Application Number : 211358
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : GRANULE;ORAL
Dosage Strength : 188MG/PACKET;150MG/PACKET
Packaging :
Approval Date : 2018-08-07
Application Number : 211358
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : GRANULE;ORAL
Dosage Strength : 94MG/PACKET;75MG/PACKET
Packaging :
Approval Date : 2022-09-02
Application Number : 211358
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG,75MG,50MG; 150MG
Packaging :
Approval Date : 2019-10-21
Application Number : 212273
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG,37.5MG,25MG; 75MG
Packaging :
Approval Date : 2021-06-08
Application Number : 212273
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : GRANULES;ORAL
Dosage Strength : 80MG, 60MG, 40MG;59.5MG
Packaging :
Approval Date : 2023-04-26
Application Number : 217660
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : GRANULES;ORAL
Dosage Strength : 100MG, 75MG, 50MG;75MG
Packaging :
Approval Date : 2023-04-26
Application Number : 217660
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Kalydeco
Dosage Form : FILM COATED PILL
Dosage Strength : 150 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Kalydeco
Dosage Form : GRANULES IN SACHET
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Kalydeco
Dosage Form : GRANULES IN SACHET
Dosage Strength : 75 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Kalydeco
Dosage Form : Ivacaftor 150Mg 56 Combined Oral Use
Dosage Strength : 56 cpr riv 150 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Kalydeco
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 150 mg
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Kalydeco
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 150 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Kalydeco
Dosage Form : Granules
Dosage Strength : 50 mg
Packaging : Dose Bag
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Kalydeco
Dosage Form : Granules
Dosage Strength : 75 mg
Packaging : Dose Bag
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Orkambi
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 200MG; 125MG
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Kalydeco
Dosage Form : Granules in a dose bag
Dosage Strength : 75 mg
Packaging : Dosepose 28 1item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Kalydeco
Dosage Form : Granules in a dose bag
Dosage Strength : 59,5 mg
Packaging : Dosepose 28 1item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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