ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

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01 1ChemExpress
02 2Metrochem API Private Limited
03 1Ami Lifesciences Private Limited
04 1Honour Lab Limited
05 1ApiSyn
06 1Accent Biosciences
07 1Alivus Life Sciences
08 1Aptra Synthesis
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01 1307MF10084
02 1307MF10106
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01 1WC-0054
02 1WC-0310
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01 11574-5-ND
02 12572-6-ND
03 1Su2526-4-ND
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05 1Su289-28-ND
06 1Su434-50-ND
07 1Su69-21-ND
08 1Su812-18-ND
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01 142765-027
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ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35576
Submission : 2021-03-29
Status : Active
Type : II
Registration Number : 307MF10084
Registrant's Address : Flat No. 302, Bhanu Enclave, Sunder Nagar, Erragadda, Hyderabad - 500038, Telangana, India
Initial Date of Registration : 2025-07-16
Latest Date of Registration :
NDC Package Code : 42765-064
Start Marketing Date : 2023-10-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-02-28
Registration Number : Su289-28-ND
Manufacturer Name : Metrochem API Private Limited
Manufacturer Address : Unit – IV, Plot No. 34B, 40B & 60B, JN Pharma City, Thanam(V), Parawada (M), Anakapalli District-531021, Andhra Pradesh, India
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-11-28
Registration Number : Su434-50-ND
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India
| Available Reg Filing : CN |
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
NDC Package Code : 42765-027
Start Marketing Date : 2021-03-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-01-24
Registration Number : Su289-27-ND
Manufacturer Name : Metrochem API Pvt Ltd, Unit- IV
Manufacturer Address : Plot No. 34B, 40B & 60B, JN Pharma City, Thanam (V) Parawada (M), Anakapalli District – 531 021, Andhra Pradesh, India.

Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2025-04-07
Registration Number : Su69-21-ND
Manufacturer Name : Precise Biopharma Pvt. Ltd.
Manufacturer Address : Plot No. D-90/3, TTC Industrial Area, MIDC, Turbhe, Mumbai-400705, Maharashtra State, India

Date of Issue : 2023-11-28
Valid Till : 2026-11-28
Written Confirmation Number : WC-0310
Address of the Firm :
Registrant Name : Mpeak Korea Co., Ltd.
Registration Date : 2022-10-11
Registration Number : Su812-18-ND
Manufacturer Name : Alivus Life Sciences Limited
Manufacturer Address : Plot No.Z-103/ I, DAHEJ SEZ Phase II, City : Dahej, District : Bharuch, Gujarat State, India


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PharmaCompass offers a list of Teneligliptin Hydrobromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Teneligliptin Hydrobromide manufacturer or Teneligliptin Hydrobromide supplier for your needs.
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