Neuland Laboratories- A dedicated 100% API provider.
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01 1Neuland Laboratories
02 1Vtides Life Sciences
03 1Chunghwa Chemical Synthesis & Biotech
04 1Omgene Life Sciences Pvt. Ltd
05 1ALP Pharm
06 1Changzhou Pharmaceutical Factory
07 1Cipla
08 1Jiangsu Sinopep Allsino Biopharmaceutical
09 1MSN Laboratories
10 1PolyPeptide Group
11 1Sandoo Pharmaceuticals and Chemcials Co.,Ltd
12 1Wisdom Pharmaceutical
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01 5China
02 5India
03 1Switzerland
04 1Taiwan
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01 6Active
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01 1304MF10128
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01 152076-6273
02 159162-0002
03 169766-115
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41503
Submission : 2025-03-26
Status : Active
Type : II
Vtides Life Sciences: Innovating peptide design and synthesis for advanced, targeted therapies across key disease areas.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38511
Submission : 2023-06-19
Status : Active
Type : II
NDC Package Code : 52076-6273
Start Marketing Date : 2021-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
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 : 38645
Submission : 2023-08-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40537
Submission : 2024-09-27
Status : Active
Type : II
NDC Package Code : 69766-115
Start Marketing Date : 2024-09-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41341
Submission : 2025-02-21
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-03-28
Pay. Date : 2025-03-12
DMF Number : 37712
Submission : 2023-01-25
Status : Active
Type : II
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