DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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01 2Dr. Reddy's Laboratories
02 1Polpharma
03 1Moehs Iberica
04 1Aarti Pharmalabs
05 1Ami Lifesciences Private Limited
06 1Almelo
07 1Aurore Life Sciences
08 2Biocon
09 1CHEMO
10 1Cipla
11 1Harman Finochem
12 1Hetero Drugs
13 1Hikal
14 1Laurus Labs
15 1Lee Pharma
16 1Livmore Life Sciences
17 1MSN Laboratories
18 1SMS Pharmaceuticals
19 1Viatris
20 1Zhejiang Jingsheng Pharmaceutical
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01 1China
02 17India
03 1Poland
04 2Spain
05 1U.S.A
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01 6Active
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01 1WC-0022
02 1WC-0045nA2
03 1WC-0067
04 1WC-0099
05 1WC-0100N1
06 1WC-0186
07 1WC-0373
08 1WC-0390
09 1WC-0459A3
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-18
Pay. Date : 2020-09-16
DMF Number : 34400
Submission : 2019-12-30
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm :
NDC Package Code : 71796-016
Start Marketing Date : 2019-12-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2021-11-30
Registration Number : No. 574-20-ND
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : CTO-SEZ Process Unit-01, Sector No.'s 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey No.'s 57 to 58, 60, 72 to 73, 76 to 77 & 80, Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District 532409, Andhra Pradesh, India
Available Reg Filing : ASMF, BR, RU |
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36129
Submission : 2021-07-19
Status : Active
Type : II
Available Reg Filing : ASMF |
Registrant Name : Donggu Biopharmaceutical Co., Ltd.
Registration Date : 2022-12-21
Registration Number : Su207-55-ND(1)
Manufacturer Name : Benechim SRL
Manufacturer Address : Rue Rene Magritte 163 Lessines 7860 Belgium
Available Reg Filing : ASMF |
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2024-11-14
Registration Number : Number 207-69-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
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 : 71796-016
Start Marketing Date : 2019-12-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2021-11-30
Registration Number : No. 574-20-ND
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : CTO-SEZ Process Unit-01, Sector No.'s 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey No.'s 57 to 58, 60, 72 to 73, 76 to 77 & 80, Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District 532409, Andhra Pradesh, India
Available Reg Filing : ASMF, BR, RU |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39440
Submission : 2024-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37288
Submission : 2022-06-30
Status : Active
Type : II
NDC Package Code : 66651-923
Start Marketing Date : 2019-09-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-02
Pay. Date : 2022-01-20
DMF Number : 36558
Submission : 2022-02-06
Status : Active
Type : II
Date of Issue : 2022-05-06
Valid Till : 2025-07-02
Written Confirmation Number : WC-0100N1
Address of the Firm :
NDC Package Code : 65727-071
Start Marketing Date : 2021-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmasolution Co., Ltd.
Registration Date : 2019-08-12
Registration Number : Su434-10-ND(1)
Manufacturer Name : Biocon Limited
Manufacturer Address : Special Economic Zone Plot No. 2, 3, 4, Phase IV Bommasandra-Jigani Link Road Bommasandra Past Banglore-560 099, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-04-11
Pay. Date : 2024-03-21
DMF Number : 37684
Submission : 2024-03-22
Status : Active
Type : II
NDC Package Code : 65727-071
Start Marketing Date : 2021-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmasolution Co., Ltd.
Registration Date : 2019-08-12
Registration Number : Su434-10-ND(1)
Manufacturer Name : Biocon Limited
Manufacturer Address : Special Economic Zone Plot No. 2, 3, 4, Phase IV Bommasandra-Jigani Link Road Bommasandra Past Banglore-560 099, India
Date of Issue : 2023-03-21
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm :
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2024-11-12
Registration Number : Su386-2-ND
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam (village), Jinnaram (mandal), Sangareddy (district), Telangana State - 502319, India
Date of Issue : 2022-06-08
Valid Till : 2025-07-21
Written Confirmation Number : WC-0045nA2
Address of the Firm :
Date of Issue : 2022-07-08
Valid Till : 2025-07-21
Written Confirmation Number : WC-0373
Address of the Firm :
NDC Package Code : 67835-0025
Start Marketing Date : 2021-09-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-12-24
Registration Number : Number 173-32-ND
Manufacturer Name : MSN Pharmachem Private Limited
Manufacturer Address : Plot No.: 182 to 186, 192-A, 193 to 197 & 212/ A,B,C,D, Phase-II, IDA Pashamylaram, Pashamylaram (Village), Patancheru (Mandal), Sangareddy District, Pincode: 502 307 , Telangana. India. _x000D_ _x000D_
Date of Issue : 2022-06-27
Valid Till : 2022-11-27
Written Confirmation Number : WC-0459A3
Address of the Firm :
A Sitagliptin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitagliptin Hydrochloride, including repackagers and relabelers. The FDA regulates Sitagliptin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitagliptin Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Sitagliptin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sitagliptin Hydrochloride supplier is an individual or a company that provides Sitagliptin Hydrochloride active pharmaceutical ingredient (API) or Sitagliptin Hydrochloride finished formulations upon request. The Sitagliptin Hydrochloride suppliers may include Sitagliptin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sitagliptin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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