DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1COSMA S.p.A
03 1China Chemical & Pharmaceutical
04 1Cilag AG
05 1Corden Pharma Bergamo S.p.A
06 1Erregierre SpA
07 1IWAKI SEIYAKU
08 1Katwijk Chemie
09 1Olon S.p.A
10 1SIMS Srl
11 1Sumitomo Chemical
12 1Zambon Group SpA
01 1China
02 1India
03 6Italy
04 2Japan
05 1Netherlands
06 1Switzerland
01 3Active
02 7Inactive
03 2Blank
01 12Blank
01 1217MF10040
02 11Blank
01 1WC-0067
02 11Blank
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 : 55111-013
Start Marketing Date : 1999-09-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-26
Pay. Date : 2014-12-29
DMF Number : 11308
Submission : 1995-01-18
Status : Active
Type : II
NDC Package Code : 17349-0008
Start Marketing Date : 1995-01-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12911
Submission : 1998-03-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12999
Submission : 1998-05-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11748
Submission : 1995-11-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12340
Submission : 1997-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11867
Submission : 1996-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13227
Submission : 1998-09-21
Status : Inactive
Type : II
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-54-C-180-03
Manufacturer Name : Zambon Group SpA
Manufacturer Address : Via Dovaro 36045 Almisano di Lonigo (Vicenza) (Via della Chimica, 9, 36100 Vicenza), , Italy_x000D_
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15484
Submission : 2001-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14059
Submission : 1999-04-05
Status : Inactive
Type : II
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