LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Bachem AG
03 1Omgene Life Sciences Pvt. Ltd
04 1ALP Pharm
05 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
06 1BCN Peptides
07 1Chinese Peptide Company
08 1Hybio Pharmaceutical
09 1MSN Laboratories
10 1Mallinckrodt Pharmaceuticals
11 3PolyPeptide Group
12 1RANBAXY LABORATORIES LIMITED
13 1Savior Lifetec Corporation
14 1Shenzhen JYMed Technology
15 1Smaart Pharmaceutticals
16 1TAPI Technology & API Services
17 1Teva Pharmaceutical Industries
01 5China
02 4India
03 1Ireland
04 2Israel
05 1Spain
06 4Switzerland
07 1Taiwan
08 1U.S.A
01 8Active
02 1Inactive
03 10Blank
01 19Blank
01 1221MF10169
02 1223MF10041
03 17Blank
01 1WC-0047a3
02 18Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-21
Pay. Date : 2013-09-16
DMF Number : 17227
Submission : 2004-03-05
Status : Active
Type : II
NDC Package Code : 52416-105
Start Marketing Date : 2005-04-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34566
Submission : 2020-02-17
Status : Active
Type : II
NDC Package Code : 69766-078
Start Marketing Date : 2020-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19646
Submission : 2006-07-31
Status : Active
Type : II
Registration Number : 223MF10041
Registrant's Address : Chausse(')e de Tubize 297, Braine-L'Alleud, 1420, Belgium
Initial Date of Registration : 2011-03-10
Latest Date of Registration : --
Date of Issue : 2020-01-28
Valid Till : 2022-06-27
Written Confirmation Number : WC-0047a3
Address of the Firm :
NDC Package Code : 59149-004
Start Marketing Date : 2023-02-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (250g/250g)
Marketing Category : BULK INGREDIENT
Registrant Name : Meditip Co., Ltd.
Registration Date : 2022-04-28
Registration Number : Su233-2-ND
Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd.
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-29
Pay. Date : 2013-12-13
DMF Number : 27714
Submission : 2014-01-13
Status : Active
Type : II
NDC Package Code : 59149-004
Start Marketing Date : 2023-02-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (250g/250g)
Marketing Category : BULK INGREDIENT
Registrant Name : Meditip Co., Ltd.
Registration Date : 2022-04-28
Registration Number : Su233-2-ND
Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd.
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30924
Submission : 2016-09-28
Status : Active
Type : II
NDC Package Code : 59149-004
Start Marketing Date : 2023-02-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (250g/250g)
Marketing Category : BULK INGREDIENT
Registrant Name : Meditip Co., Ltd.
Registration Date : 2022-04-28
Registration Number : Su233-2-ND
Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd.
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35476
Submission : 2020-12-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-02-04
Pay. Date : 2015-10-07
DMF Number : 29863
Submission : 2015-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17114
Submission : 2004-01-19
Status : Inactive
Type : II
Registration Number : 221MF10169
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2009-07-30
Latest Date of Registration : --
NDC Package Code : 0406-7310
Start Marketing Date : 2013-11-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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