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 1TAPI Technology & API Services
05 1ALP Pharm
06 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
07 1BCN Peptides
08 1Chinese Peptide Company
09 1Hybio Pharmaceutical
10 1MSN Laboratories
11 1Mallinckrodt Pharmaceuticals
12 3PolyPeptide Group
13 1RANBAXY LABORATORIES LIMITED
14 1Savior Lifetec Corporation
15 1Shenzhen JYMed Technology
16 1Smaart Pharmaceutticals
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 1223MF10041
02 18Blank
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 : 2025-12-31
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 : Reviewed
Rev. Date : 2013-08-19
Pay. Date : 2013-05-09
DMF Number : 27123
Submission : 2013-07-07
Status : Active
Type : II
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 : 2025-12-31
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 : 2025-12-31
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 : 2025-12-31
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 : 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
NDC Package Code : 0406-7310
Start Marketing Date : 2013-11-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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