01 1Anhui HaiKang Pharmaceutical
02 1Aspen Biopharma Labs
03 1Aurobindo Pharma Limited
04 1Bakul Group
05 1CHANGZHOU KONY PHARMACEUTICAL CO., LTD. CN 213 105 Changzhou
06 1Charioteer
07 1Fareva
08 1Hainan Poly Pharm
09 1Hetero Drugs
10 1RANBAXY LABORATORIES LIMITED
11 1Shouyuan Chemical
12 1Sibbiotech
13 1Sujalam Chemicals
14 1Trifarma
15 1Unimark Remedies Limited
16 1Unipex
01 5China
02 1France
03 7India
04 1Italy
05 1Luxembourg
06 1Russia
01 4Active
02 2Inactive
03 10Blank
01 2Valid
02 14Blank
01 1222MF10281
02 15Blank
01 1WC-0066
02 1WC-0170
03 14Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-08
DMF Number : 15567
Submission : 2001-07-31
Status : Active
Type : II
Certificate Number : R1-CEP 2010-257 - Rev 03
Issue Date : 2021-09-30
Type : Chemical
Substance Number : 1752
Status : Valid
Registration Number : 222MF10281
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2010-12-24
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-02
Pay. Date : 2015-08-07
DMF Number : 28973
Submission : 2015-04-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-07
Pay. Date : 2017-02-15
DMF Number : 31402
Submission : 2017-02-18
Status : Active
Type : II
NDC Package Code : 59651-108
Start Marketing Date : 2024-01-11
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 : 23721
Submission : 2010-04-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16043
Submission : 2002-07-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27133
Submission : 2013-05-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 2013-123 - Rev 01
Issue Date : 2019-06-20
Type : Chemical
Substance Number : 1752
Status : Valid
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm :
A Ganciclovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganciclovir, including repackagers and relabelers. The FDA regulates Ganciclovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganciclovir 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 Ganciclovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganciclovir supplier is an individual or a company that provides Ganciclovir active pharmaceutical ingredient (API) or Ganciclovir finished formulations upon request. The Ganciclovir suppliers may include Ganciclovir API manufacturers, exporters, distributors and traders.
click here to find a list of Ganciclovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 16 companies offering Ganciclovir
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