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

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01 1LGM Pharma
02 1HRV Pharma
03 1Pharmathen SA
04 1Maithri Drugs
05 1Enaltec Labs
06 1Fareva
07 1Vital Laboratories Private Limited
08 1Ajanta Pharma Limited
09 1Amara Labs
10 1Anthem Biosciences
11 1Apotex Pharmachem
12 1Arene Lifesciences
13 1Aspire Lifesciences Pvt Ltd
14 2Aurobindo Pharma Limited
15 1Aurore Life Sciences
16 1Calyx Chemicals & Pharmaceuticals
17 3Charioteer
18 1Cipla
19 1CordenPharma
20 1DEAFARMA
21 1Dasami Lab
22 1Dishman Carbogen Amcis
23 1Guangzhou Tosun Pharmaceutical
24 2Hetero Drugs
25 1Hubei Gedian Humanwell Pharmaceutical
26 1MSN Laboratories
27 1Maithili Life Sciences
28 1Matrix Pharmaceutical Inc
29 4Olon S.p.A
30 1Rakshit Drugs
31 1Shanghai Pharma Group
32 1Shouyuan Chemical
33 1Srini Pharmaceuticals
34 2Sun Pharmaceutical Industries Limited
35 1Synthimed Labs
36 1Tianish Laboratories
37 2Viatris
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01 1Canada
02 7China
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05 26India
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08 4U.S.A
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01 17Active
02 5Inactive
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01 7Valid
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01 1WC-0023
02 1WC-003
03 1WC-0118
04 1WC-0144
05 1WC-0455
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01 112869-038
02 117337-0040
03 117337-0084
04 117337-0320
05 117337-0327
06 161876-0072
07 163310-2410
08 165862-756
09 165977-0070
10 166639-010
11 169875-8044
12 170966-0037
13 171666-008
14 172761-029
15 184206-0098
16 184386-185
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2025-09-26
Pay. Date : 2025-08-21
DMF Number : 42083
Submission : 2025-06-25
Status : Active
Type : II

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
Certificate Number : CEP 2024-326 - Rev 00
Issue Date : 2025-11-21
Type : Chemical
Substance Number : 2930
Status : Valid
NDC Package Code : 69875-8044
Start Marketing Date : 2021-07-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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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.
click here to find a list of Valcyte suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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