LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1HRV Global Life Sciences
03 1Honour Lab
04 1ACS DOBFAR SPA
05 1Acebright India Pharma Private Limited
06 1Amara Labs
07 1Anhui Biochem Pharmaceutical
08 1Arene Lifesciences
09 1Aspire Lifesciences Pvt Ltd
10 1Aurobindo Pharma Limited
11 1Catalent Pharma Solutions
12 1Chromo Laboratories
13 1Cipla
14 1Dalian Richon Chem
15 1Guangzhou Tosun Pharmaceutical
16 3Hetero Drugs
17 1Itelyum Purification
18 1Laurus Labs
19 1Lupin Ltd
20 1Macleods Pharmaceuticals Limited
21 1Neha Chemicals
22 1SMS Pharmaceuticals
23 2Shanghai Desano Chemical Pharmaceutical Co., Ltd.
24 1Sun Pharmaceutical Industries Limited
25 1Symed Labs
26 1Tecoland Corporation
27 1Tianish Laboratories
28 2Viatris
29 1Viyash Life Sciences
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01 5China
02 21India
03 2Italy
04 5U.S.A
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01 11Active
02 3Inactive
03 19Blank
01 4Valid
02 2Withdrawn by Holder
03 27Blank
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01 33Blank
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01 1WC-0023
02 1WC-0041
03 1WC-0066
04 1WC-0118
05 1WC-0373
06 1WC-0459
07 1WC-0487
08 26Blank
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01 12578-2-ND
02 1Su434-19-ND
03 31Blank
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01 153104-7709
02 165015-685
03 165862-265
04 165977-0064
05 168554-0019
06 168554-0138
07 169037-0057
08 184206-0060
09 25Blank
01 33Blank
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.
NDC Package Code : 69037-0057
Start Marketing Date : 2000-09-15
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 : 20363
Submission : 2007-05-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34744
Submission : 2020-04-12
Status : Active
Type : II
Date of Issue : 2023-12-26
Valid Till : 2026-12-03
Written Confirmation Number : WC-0487
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30154
Submission : 2015-12-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34144
Submission : 2019-09-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-07-11
Pay. Date : 2019-06-10
DMF Number : 33919
Submission : 2019-06-25
Status : Active
Type : II
Certificate Number : R0-CEP 2020-103 - Rev 01
Issue Date : 2023-01-25
Type : Chemical
Substance Number : 2615
Status : Valid
Date of Issue : 2022-12-02
Valid Till : 2025-11-27
Written Confirmation Number : WC-0459
Address of the Firm :
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-07-20
Registration Number : Su434-19-ND
Manufacturer Name : Laurus Labs Limited(Unit-4)
Manufacturer Address : Plot No. 25, 25A to 25K, Lalamkoduru Village, Rambilli Mandal, Visakhapatnam - 531011, Andhra Pradesh, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19600
Submission : 2006-07-17
Status : Inactive
Type : II
Date of Issue : 2022-07-06
Valid Till : 2025-08-04
Written Confirmation Number : WC-0118
Address of the Firm :
NDC Package Code : 65015-685
Start Marketing Date : 2015-08-20
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 : 21101
Submission : 2007-12-03
Status : Inactive
Type : II
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A KALETRA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of KALETRA, including repackagers and relabelers. The FDA regulates KALETRA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. KALETRA 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 KALETRA supplier is an individual or a company that provides KALETRA active pharmaceutical ingredient (API) or KALETRA finished formulations upon request. The KALETRA suppliers may include KALETRA API manufacturers, exporters, distributors and traders.
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We have 29 companies offering KALETRA
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