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

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01 1305MF10101
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01 1SD230058
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01 116436-0091
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 23414
Submission : 2009-12-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-23
Pay. Date : 2021-10-29
DMF Number : 36392
Submission : 2021-10-12
Status : Active
Type : II
Registration Number : 305MF10101
Registrant's Address : No. 77D & 116/117, KIADB Industrial Area, Jigani, Phase - 2, Anekal Taluk, Bangalore - 560105, India
Initial Date of Registration : 2023-08-30
Latest Date of Registration :
Date of Issue : 2024-05-20
Valid Till : 2027-07-15
Written Confirmation Number : WC-0327
Address of the Firm :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29653
Submission : 2021-04-21
Status : Active
Type : II
Date of Issue : 2026-01-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0147
Address of the Firm :
NDC Package Code : 82920-037
Start Marketing Date : 2023-09-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-27
Pay. Date : 2018-10-29
DMF Number : 33085
Submission : 2018-09-19
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-06
Pay. Date : 2019-01-28
DMF Number : 32927
Submission : 2019-03-15
Status : Active
Type : II
Date of Issue : 2021-01-08
Valid Till : 2022-07-25
Written Confirmation Number : WC-0159A3
Address of the Firm :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26464
Submission : 2012-09-18
Status : Inactive
Type : II

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PharmaCompass offers a list of Sunitinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sunitinib manufacturer or Sunitinib supplier for your needs.
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A Sunitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sunitinib, including repackagers and relabelers. The FDA regulates Sunitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sunitinib 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 Sunitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sunitinib supplier is an individual or a company that provides Sunitinib active pharmaceutical ingredient (API) or Sunitinib finished formulations upon request. The Sunitinib suppliers may include Sunitinib API manufacturers, exporters, distributors and traders.
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