LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Nuray Chemicals Private Limited
03 1HRV Global Life Sciences
04 1Neuland Laboratories
05 2TAPI Technology & API Services
06 1American Pacific Corporation
07 1Aspire Lifesciences Pvt Ltd
08 1COSMA S.p.A
09 1Cadila Pharmaceuticals
10 1Cambrex Corporation
11 1Erregierre SpA
12 1Flamma SpA
13 1GSK
14 1Glenmark Life Sciences
15 1Glenmark Pharmaceuticals
16 1Macleods Pharmaceuticals Limited
17 1Olon S.p.A
18 2Procos
19 1Sicor Societa Italiana Corticosteroidi Srl
20 1Sifavitor srl
21 1Solara Active Pharma Sciences
22 1Sriam Labs
23 1Srini Pharmaceuticals
24 1Symed Labs
25 1UQUIFA
26 1Unichem Laboratories Limited
27 1Unipex
28 1Viatris
29 1Viyash Life Sciences
30 1Zydus Lifesciences
01 1France
02 15India
03 2Israel
04 8Italy
05 1Spain
06 4U.S.A
07 1United Kingdom
01 14Active
02 5Inactive
03 13Blank
01 5Valid
02 2Withdrawn by Holder
03 25Blank
01 1218MF10819
02 1218MF10992
03 1224MF10101
04 1226MF10014
05 28Blank
01 1WC-0037
02 1WC-0074
03 1WC-0228
04 1WC-0313
05 28Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-31
Pay. Date : 2017-01-11
DMF Number : 30564
Submission : 2016-06-07
Status : Active
Type : II
Certificate Number : CEP 2016-222 - Rev 04
Issue Date : 2024-05-07
Type : Chemical
Substance Number : 923
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-2025
Start Marketing Date : 2016-07-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10901
Submission : 1994-05-18
Status : Inactive
Type : II
Registration Number : 218MF10819
Registrant's Address : Via Messina, 38, 20154 Milano Italy
Initial Date of Registration : 2006-10-06
Latest Date of Registration : --
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 : 2014-03-06
Pay. Date : 2014-03-04
DMF Number : 16314
Submission : 2002-12-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-24
Pay. Date : 2013-06-18
DMF Number : 10918
Submission : 1994-06-08
Status : Active
Type : II
Registration Number : 224MF10101
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2012-05-25
Latest Date of Registration : --
NDC Package Code : 46016-0117
Start Marketing Date : 1994-06-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35233
Submission : 2021-11-17
Status : Active
Type : II
NDC Package Code : 50683-0590
Start Marketing Date : 2021-04-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-01
Pay. Date : 2021-01-19
DMF Number : 34099
Submission : 2020-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38064
Submission : 2023-03-30
Status : Active
Type : II
NDC Package Code : 66039-962
Start Marketing Date : 2022-08-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-16
Pay. Date : 2019-03-15
DMF Number : 11779
Submission : 1995-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37856
Submission : 2022-12-26
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-09-07
Pay. Date : 2023-07-26
DMF Number : 37306
Submission : 2022-08-09
Status : Active
Type : II
Certificate Number : CEP 2022-315 - Rev 00
Issue Date : 2024-08-23
Type : Chemical
Substance Number : 923
Status : Valid
NDC Package Code : 82245-0203
Start Marketing Date : 1987-04-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-01
Pay. Date : 2021-04-12
DMF Number : 34073
Submission : 2019-08-29
Status : Active
Type : II
Certificate Number : R0-CEP 2021-241 - Rev 00
Issue Date : 2023-08-23
Type : Chemical
Substance Number : 923
Status : Valid
Date of Issue : 2019-05-21
Valid Till : 2022-05-21
Written Confirmation Number : WC-0313
Address of the Firm :
NDC Package Code : 66174-0003
Start Marketing Date : 2019-02-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-04-17
Pay. Date : 2017-03-27
DMF Number : 31584
Submission : 2017-03-29
Status : Active
Type : II
NDC Package Code : 53747-037
Start Marketing Date : 2017-03-29
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 : 12758
Submission : 1997-11-24
Status : Active
Type : II
NDC Package Code : 12828-0070
Start Marketing Date : 1996-11-11
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 : 14702
Submission : 2000-02-04
Status : Active
Type : II
NDC Package Code : 51604-0017
Start Marketing Date : 2009-10-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23710
Submission : 2010-04-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17319
Submission : 2004-04-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19366
Submission : 2006-04-14
Status : Inactive
Type : II
Certificate Number : R0-CEP 2008-057 - Rev 04
Issue Date : 2013-07-17
Type : Chemical
Substance Number : 923
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9927
Submission : 1992-10-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5715
Submission : 1985-02-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-119 - Rev 01
Issue Date : 2008-07-16
Type : Chemical
Substance Number : 923
Status : Withdrawn by Holder
Date of Issue : 2019-08-13
Valid Till : 2022-08-12
Written Confirmation Number : WC-0228
Address of the Firm :
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074
Address of the Firm :
Certificate Number : R1-CEP 2004-289 - Rev 05
Issue Date : 2022-03-11
Type : Chemical
Substance Number : 923
Status : Valid
NDC Package Code : 17337-0523
Start Marketing Date : 2017-03-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2010-226 - Rev 04
Issue Date : 2024-10-24
Type : Chemical
Substance Number : 923
Status : Valid
A Labetalol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Labetalol Hydrochloride, including repackagers and relabelers. The FDA regulates Labetalol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Labetalol Hydrochloride 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 Labetalol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Labetalol Hydrochloride supplier is an individual or a company that provides Labetalol Hydrochloride active pharmaceutical ingredient (API) or Labetalol Hydrochloride finished formulations upon request. The Labetalol Hydrochloride suppliers may include Labetalol Hydrochloride API manufacturers, exporters, distributors and traders.
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