LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Dr. Reddy's Laboratories
03 1HRV Global Life Sciences
04 1Pharmathen SA
05 1Ajanta Pharma Limited
06 1Amara Labs
07 1Anthem Biosciences
08 1Apotex Pharmachem
09 1Arene Lifesciences
10 1Aspire Lifesciences Pvt Ltd
11 1Aurobindo Pharma Limited
12 1Aurore Life Sciences
13 1Calyx Chemicals & Pharmaceuticals Limited
14 3Charioteer
15 1Cipla
16 1CordenPharma
17 1DEAFARMA
18 2Dishman Carbogen Amcis
19 1Everest Organics
20 1Guangzhou Tosun Pharmaceutical
21 2Hetero Drugs
22 1Ind Swift Laboratories Limited
23 1Maithri Drugs
24 4Olon S.p.A
25 2RANBAXY LABORATORIES LIMITED
26 1Rakshit Drugs
27 1Shanghai Pharma Group
28 1Shouyuan Chemical
29 1Sun Pharmaceutical Industries Limited
30 1Tecoland Corporation
31 2Viatris
32 1Vital Laboratories Private Limited
01 1Canada
02 6China
03 1Germany
04 1Greece
05 23India
06 5Italy
07 4U.S.A
01 17Active
02 5Inactive
03 19Blank
01 3Valid
02 38Blank
01 41Blank
01 1WC-0003
02 1WC-0011nA2
03 1WC-0067
04 1WC-0118
05 1WC-0119
06 1WC-0128
07 1WC-0135
08 1WC-0135A
09 1WC-0144nA2
10 1WC-0455
11 31Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-884
Start Marketing Date : 2011-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-07
Pay. Date : 2017-04-28
DMF Number : 31546
Submission : 2017-05-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30023
Submission : 2015-11-12
Status : Active
Type : II
NDC Package Code : 12869-038
Start Marketing Date : 2001-03-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-21
DMF Number : 23044
Submission : 2009-08-04
Status : Active
Type : II
NDC Package Code : 17337-0040
Start Marketing Date : 2015-05-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-30
Pay. Date : 2020-09-29
DMF Number : 34617
Submission : 2020-02-29
Status : Active
Type : II
Date of Issue : 2022-11-18
Valid Till : 2025-09-30
Written Confirmation Number : WC-0455
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-13
Pay. Date : 2021-09-29
DMF Number : 35107
Submission : 2021-09-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19060
Submission : 2005-12-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23946
Submission : 2010-07-06
Status : Inactive
Type : II
A Valcyte manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valcyte, including repackagers and relabelers. The FDA regulates Valcyte manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valcyte 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 Valcyte supplier is an individual or a company that provides Valcyte active pharmaceutical ingredient (API) or Valcyte finished formulations upon request. The Valcyte suppliers may include Valcyte API manufacturers, exporters, distributors and traders.
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