LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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01 1LGM Pharma
02 1Metrochem API Private Limited
03 1HRV Pharma
04 1Neuland Laboratories
05 1Maithri Drugs
06 1Lupin Manufacturing Solutions
07 1ApiSyn
08 1AR Life Sciences
09 1Alborz Pharmed
10 1Alembic Pharmaceuticals Limited
11 1Alivus Life Sciences
12 1Alkem Laboratories
13 1Apicore
14 2Aurobindo Pharma Limited
15 1Aurore Life Sciences
16 1Biocon
17 1Cipla
18 1DEAFARMA
19 1Glenmark Pharmaceuticals
20 1Hangzhou Longshine Bio-Tech
21 1Hetero Drugs
22 2Hovione
23 1Laurus Labs
24 2MSN Laboratories
25 2Medichem S.A
26 1Phalanx Labs
27 1Prague Scientific
28 1ScinoPharm Taiwan Ltd
29 1Smilax Laboratories Limited
30 1Sun Pharmaceutical Industries Limited
31 1Synthimed Labs
32 2Vindhya Organics
33 1WuXi AppTec
34 1Zydus Lifesciences
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01 2China
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01 17Active
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01 2WC-0017
02 2WC-0021
03 1WC-0057n
04 1WC-0082
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01 114501-0019
02 116436-0132
03 124538-770
04 150909-1902
05 151473-1901
06 153296-0132
07 159651-588
08 159651-603
09 165129-1450
10 165727-095
11 166039-900
12 168554-0168
13 182245-0123
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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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42858
Submission : 2025-11-01
Status : Active
Type : II
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
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 : 2015-05-19
Pay. Date : 2015-03-10
DMF Number : 28867
Submission : 2015-03-10
Status : Active
Type : II
Date of Issue : 2022-07-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :

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

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PharmaCompass offers a list of Ivacaftor API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ivacaftor manufacturer or Ivacaftor supplier for your needs.
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A Kalydeco manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kalydeco, including repackagers and relabelers. The FDA regulates Kalydeco manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kalydeco API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Kalydeco supplier is an individual or a company that provides Kalydeco active pharmaceutical ingredient (API) or Kalydeco finished formulations upon request. The Kalydeco suppliers may include Kalydeco API manufacturers, exporters, distributors and traders.
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We have 33 companies offering Kalydeco
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