LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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03 1Canada
04 4China
05 17India
06 1Israel
07 1Malta
08 2Spain
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11 3U.S.A
01 13Active
02 3Inactive
03 17Blank
01 33Blank
01 33Blank
01 1WC-0027
02 1WC-0057n
03 1WC-0067
04 1WC-0079
05 1WC-0152
06 1WC-0157
07 1WC-0182
08 1WC-0225
09 1WC-0317A2
10 1WC-0370n
11 23Blank
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 : 55111-900
Start Marketing Date : 2010-01-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-20
Pay. Date : 2016-06-16
DMF Number : 30600
Submission : 2016-06-21
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-25
Pay. Date : 2013-09-12
DMF Number : 27448
Submission : 2013-09-10
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-0225
Address of the Firm :
NDC Package Code : 42571-280
Start Marketing Date : 2013-09-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2020-01-21
Registration Number : Su469-2-ND
Manufacturer Name : Micro Labs Limited
Manufacturer Address : Plot No.43-45, KIADB, Jigani Bommasandra Link Road, Anekal Taluk, Bengaluru 560 105, Karnataka, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22782
Submission : 2009-05-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-28
Pay. Date : 2016-06-08
DMF Number : 22366
Submission : 2008-12-30
Status : Active
Type : II
Date of Issue : 2019-10-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0157
Address of the Firm :
NDC Package Code : 65015-775
Start Marketing Date : 2015-02-19
End Marketing Date : 2026-12-01
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2019-04-10
Registration Number : Su289-6-ND
Manufacturer Name : Mylan Laboratories Limited@Viyash Life Sciences Private Limited
Manufacturer Address : Plot No.1A/2, MIDC Industrial Estate Taloja, Panvel, Dist : Raigad Maharashtra Raigad 410208 Maharashtra State, India@Plot No.1-A/2 & Plot No. 1-A/3, MIDC Taloja Industrial Area, Taloja - 410208 Taluka: Panvel, District RAIGAD. Maharashtra, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25366
Submission : 2011-10-06
Status : Active
Type : II
NDC Package Code : 57741-1900
Start Marketing Date : 2006-05-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2022-12-06
Registration Number : 69-14-ND
Manufacturer Name : Maprimed SA
Manufacturer Address : Coronel Prudencio Murguiondo 2011, Buenos Aires, Argentina
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-06
Pay. Date : 2013-02-21
DMF Number : 24159
Submission : 2010-09-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-06
Pay. Date : 2013-09-26
DMF Number : 26706
Submission : 2012-12-24
Status : Active
Type : II
Date of Issue : 2019-11-28
Valid Till : 2022-07-02
Written Confirmation Number : WC-0079
Address of the Firm :
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2019-12-26
Registration Number : 473-24-ND
Manufacturer Name : Macleods Pharmaceuticals Limited
Manufacturer Address : Plot No.2209, GIDC Industrial Estate, At and Post Sarigam Taluka : Umbergaon City : Sarigam – 396 155, Dist : Valsad, Gujarat State, India
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