LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Metrochem API Private Limited
03 1HRV Global Life Sciences
04 1Medichem S.A
05 1Neuland Laboratories
06 1AR Life Sciences
07 1Alembic Pharmaceuticals Limited
08 1Alkem Laboratories
09 2Aurobindo Pharma Limited
10 1Aurore Life Sciences
11 1Cipla
12 1DEAFARMA
13 1Glenmark Life Sciences
14 1Glenmark Pharmaceuticals
15 1Hangzhou Longshine Bio-Tech
16 1Hetero Drugs
17 1Laurus Labs
18 1Lupin Ltd
19 1MSN Laboratories
20 1Phalanx Labs
21 1Prague Scientific
22 1ScinoPharm Taiwan, Ltd
23 1Smilax Laboratories Limited
24 1Sun Pharmaceutical Industries Limited
25 2Vindhya Organics
01 1China
02 1Czech Republic
03 21India
04 1Italy
05 1Spain
06 1Taiwan
07 1U.S.A
01 12Active
02 15Blank
01 27Blank
01 27Blank
01 1WC-0057n
02 1WC-0082
03 25Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
NDC Package Code : 16436-0132
Start Marketing Date : 2024-08-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39477
Submission : 2024-02-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35447
Submission : 2020-12-28
Status : Active
Type : II
NDC Package Code : 65129-1450
Start Marketing Date : 2020-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (7.5kg/7.5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-18
Pay. Date : 2017-06-28
DMF Number : 31849
Submission : 2017-06-30
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35586
Submission : 2021-02-11
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-19
Pay. Date : 2015-03-10
DMF Number : 28867
Submission : 2015-03-10
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :
NDC Package Code : 66039-900
Start Marketing Date : 2013-09-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-20
Pay. Date : 2020-07-02
DMF Number : 32610
Submission : 2019-03-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-10
Pay. Date : 2019-07-25
DMF Number : 33783
Submission : 2019-07-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35551
Submission : 2021-01-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35587
Submission : 2021-02-09
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-13
Pay. Date : 2021-07-07
DMF Number : 36094
Submission : 2021-07-07
Status : Active
Type : II
NDC Package Code : 59651-588
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-12
Pay. Date : 2021-08-18
DMF Number : 36209
Submission : 2021-08-19
Status : Active
Type : II
NDC Package Code : 59651-588
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-17
Pay. Date : 2023-08-29
DMF Number : 29398
Submission : 2015-05-30
Status : Active
Type : II
NDC Package Code : 14501-0019
Start Marketing Date : 2015-01-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 68554-0168
Start Marketing Date : 2012-01-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Ivacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivacaftor, including repackagers and relabelers. The FDA regulates Ivacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivacaftor API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ivacaftor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ivacaftor supplier is an individual or a company that provides Ivacaftor active pharmaceutical ingredient (API) or Ivacaftor finished formulations upon request. The Ivacaftor suppliers may include Ivacaftor API manufacturers, exporters, distributors and traders.
click here to find a list of Ivacaftor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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