DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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01 1Dr. Reddy's Laboratories
02 1China Chemical & Pharmaceutical
03 1Cilag AG
04 1Corden Pharma Bergamo S.p.A
05 1Erregierre SpA
06 1IWAKI SEIYAKU
07 1Katwijk Chemie
08 1Olon S.p.A
09 1SIMS Srl
10 1Sumitomo Chemical
11 1Zambon Group SpA
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02 1India
03 5Italy
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06 1Switzerland
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01 2Active
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01 1217MF10040
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01 120050831-54-C-180-03
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01 117349-0008
02 155111-013
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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NDC Package Code : 55111-013
Start Marketing Date : 1999-09-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
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 : 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 : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

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 : 14059
Submission : 1999-04-05
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13119
Submission : 1998-08-11
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 : 15484
Submission : 2001-06-14
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 : Sam-O 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_

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A Prestwick3_001060 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_001060, including repackagers and relabelers. The FDA regulates Prestwick3_001060 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_001060 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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