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

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01 1LGM Pharma
02 1Gonane Pharma
03 1Acebright India Pharma Private Limited
04 1Anhui Biochem Pharmaceutical
05 1Arene Lifesciences
06 1Aspire Lifesciences Pvt Ltd
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08 1Cdymax
09 1Chromo Laboratories
10 1Cipla
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16 2Lupin Ltd
17 2Matrix Pharmaceutical Inc
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19 1Olon S.p.A
20 1Piramal Enterprises Limited
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22 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
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24 1Sinopharm Weiqida Pharmaceutical Co Ltd
25 1Symed Labs
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01 4China
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01 12Active
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01 1229MF10171
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01 1WC-0015
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01 189-7-ND
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01 117337-0001
02 152562-036
03 153104-7558
04 159651-946
05 161187-010
06 161876-0718
07 163379-049
08 165085-0024
09 165862-256
10 168554-0032
11 168554-0063
12 182245-0207
13 184206-0001
14 184206-0002
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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.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-15
Pay. Date : 2014-07-07
DMF Number : 23644
Submission : 2010-03-19
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-16
Pay. Date : 2017-05-11
DMF Number : 18229
Submission : 2005-03-30
Status : Active
Type : II
Date of Issue : 2023-05-10
Valid Till : 2026-05-10
Written Confirmation Number : WC-0015
Address of the Firm :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20515
Submission : 2007-05-08
Status : Active
Type : II
NDC Package Code : 17337-0001
Start Marketing Date : 2012-12-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36967
Submission : 2024-08-14
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-20
Pay. Date : 2014-11-21
DMF Number : 28818
Submission : 2014-12-15
Status : Active
Type : II
Certificate Number : CEP 2014-353 - Rev 02
Issue Date : 2024-11-27
Type : Chemical
Substance Number : 2589
Status : Valid

GDUFA
DMF Review : Reviewed
Rev. Date : 2018-09-27
Pay. Date : 2018-08-23
DMF Number : 33031
Submission : 2018-08-30
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-27
Pay. Date : 2012-11-20
DMF Number : 23618
Submission : 2010-04-08
Status : Active
Type : II
Certificate Number : R1-CEP 2015-342 - Rev 00
Issue Date : 2022-02-24
Type : Chemical
Substance Number : 2589
Status : Valid
Registration Number : 229MF10171
Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India
Initial Date of Registration : 2017-08-28
Latest Date of Registration :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34891
Submission : 2020-09-09
Status : Inactive
Type : II

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A TRIUMEQ manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRIUMEQ, including repackagers and relabelers. The FDA regulates TRIUMEQ manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRIUMEQ 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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