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

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02 1HRV Pharma
03 1Honour Lab Limited
04 2Lupin Manufacturing Solutions
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01 1WC-0016
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01 142931-242
02 152482-016
03 152562-012
04 153044-001
05 165862-962
06 168554-0093
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm :
NDC Package Code : 69037-0044
Start Marketing Date : 2016-06-09
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-01
Pay. Date : 2017-05-18
DMF Number : 31472
Submission : 2017-04-13
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 : 2017-04-21
Pay. Date : 2017-03-29
DMF Number : 31473
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43857
Submission : 2026-03-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43326
Submission : 2025-12-16
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-06
Pay. Date : 2016-11-25
DMF Number : 30933
Submission : 2016-12-19
Status : Active
Type : II


GDUFA
DMF Review : Reviewed
Rev. Date : 2025-10-14
Pay. Date : 2025-09-29
DMF Number : 42554
Submission : 2025-09-26
Status : Active
Type : II

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A Juluca manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Juluca, including repackagers and relabelers. The FDA regulates Juluca manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Juluca 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 Juluca supplier is an individual or a company that provides Juluca active pharmaceutical ingredient (API) or Juluca finished formulations upon request. The Juluca suppliers may include Juluca API manufacturers, exporters, distributors and traders.
click here to find a list of Juluca suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 48 companies offering Juluca
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