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List of Drug Master Files (DMF) of Sitagliptin Phosphate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Dr. Reddy's Laboratories (2)

02 Moehs Iberica (2)

03 Actis Generics Pvt Ltd (1)

04 Almelo (1)

05 Ami Lifesciences Private Limited (1)

06 Amoli Organics (1)

07 Apotex Pharmachem (1)

08 Aurobindo Pharma Limited (1)

09 Beijing Huikang Boyuan Chemical Tech CO. (1)

10 Biocon (2)

11 Fuxin Long Rui Pharmaceutical (2)

12 Glenmark Life Sciences (3)

13 HEC Pharm (1)

14 HONOUR LAB LTD (2)

15 Hikal (2)

16 Jubilant Generics (1)

17 Laurus Labs (1)

18 Lee Pharma (2)

19 Lunan Pharmaceutical (1)

20 Lupin Ltd (1)

21 MSN Laboratories (4)

22 Macleods Pharmaceuticals Limited (1)

23 Mankind Pharma (1)

24 Morepen Laboratories (2)

25 Optimus Pharma (1)

26 SINTENOVO, S.A. DE C.V. (1)

27 Sichuan Xieli Pharmaceutical (1)

28 Signa S.A. de C.V. (1)

29 Sun Pharmaceutical Industries Limited (1)

30 Teva API (3)

31 Torrent Pharmaceuticals Limited (1)

32 UQUIFA (1)

33 Viatris (1)

34 Viwit Pharmaceuticals Limited (2)

35 Wockhardt (1)

36 Zhejiang Apeloa Jiayuan Pharmaceutical (2)

37 Zhejiang Changming Pharmaceuticals Co. (1)

38 Zhejiang Huahai Pharmaceutical (1)

39 Zhejiang Jiuzhou Pharmaceutical (1)

40 Zhejiang Yongtai Technology (2)

41 Zydus Lifesciences (2)

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01 3-(TRIFLUOROMETHYL)-5,6,7,8-TETRAHYDRO[1,2,4] TRIAZOLO[4,3-A] PYRAZINE HYDROCHLORIDE (1)

02 INTERMEDIATE OF SITAGLIPTIN PHOSPHATE (3R)-N-(TERT-BUTOXYCARBONYL)-3-AMINO-4-(2,4,5-TRIFLUOROPHENYL) BUTANOIC ACID) (1)

03 SITAGLIPTIN BASE (1)

04 SITAGLIPTIN FREE BASE (1)

05 SITAGLIPTIN PHOSPHATE (13)

06 SITAGLIPTIN PHOSPHATE (MONOHYDRATE) (1)

07 SITAGLIPTIN PHOSPHATE (NON-STERILE) (1)

08 SITAGLIPTIN PHOSPHATE ANHYDRATE (1)

09 SITAGLIPTIN PHOSPHATE ANHYDROUS (6)

10 SITAGLIPTIN PHOSPHATE ANHYDROUS USP (1)

11 SITAGLIPTIN PHOSPHATE ANHYDROUS USP [ROUTE CODE - SA] (1)

12 SITAGLIPTIN PHOSPHATE ANYDROUS (1)

13 SITAGLIPTIN PHOSPHATE ENZYMATIC (1)

14 SITAGLIPTIN PHOSPHATE MONOHYDRATE (10)

15 SITAGLIPTIN PHOSPHATE MONOHYDRATE (PROCESS-B) (1)

16 SITAGLIPTIN PHOSPHATE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE (1)

17 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (6)

18 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (ROUTE CODE SG) (1)

19 SITAGLIPTIN PHOSPHATE USP (8)

20 SITAGLIPTIN PHOSPHATE USP (ANHYDROUS) (1)

21 SITAGLIPTIN PHOSPHATE USP (MONOHYDRATE) (1)

22 SITAGLIPTIN PHOSPHATE USP (ROUTE-1) (1)

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01 Canada (1)

02 China (15)

03 India (35)

04 Israel (3)

05 Mexico (2)

06 Spain (3)

07 U.S.A (1)

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01 Active (56)

02 Inactive (4)

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01 Complete (35)

02 Blank (25)

URL Supplier Web Content
24266
Active
2010-10-08
Complete
2013-05-01
2013-01-09
II
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URL Supplier Web Content
25773
Active
2012-03-29
N/A
II
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URL Supplier Web Content
23864
Active
2010-06-03
Complete
2019-08-13
2019-08-06
II
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URL Supplier Web Content
24199
Active
2010-10-09
Complete
2013-01-24
2012-11-23
II
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URL Supplier Web Content
24148
Active
2010-09-09
Complete
2012-11-23
2012-11-13
II
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URL Supplier Web Content
24067
Active
2010-08-16
Complete
2013-11-08
2013-01-30
II
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Looking for 1269630-53-6 / Sitagliptin Phosphate API manufacturers, exporters & distributors?

Sitagliptin Phosphate manufacturers, exporters & distributors 1

22

PharmaCompass offers a list of Sitagliptin Phosphate 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 Sitagliptin Phosphate manufacturer or Sitagliptin Phosphate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sitagliptin Phosphate manufacturer or Sitagliptin Phosphate supplier.

PharmaCompass also assists you with knowing the Sitagliptin Phosphate API Price utilized in the formulation of products. Sitagliptin Phosphate API Price is not always fixed or binding as the Sitagliptin Phosphate Price is obtained through a variety of data sources. The Sitagliptin Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Sitagliptin Phosphate

Synonyms

654671-78-0, Sitagliptin (phosphate), Mk-0431, Chembl393336, 494p4635i6, Mk0431

Cas Number

1269630-53-6

Unique Ingredient Identifier (UNII)

494P4635I6

About Sitagliptin Phosphate

A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES.

Sitagliptin Phosphate Manufacturers

A Sitagliptin Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitagliptin Phosphate, including repackagers and relabelers. The FDA regulates Sitagliptin Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitagliptin Phosphate 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 Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Sitagliptin Phosphate Suppliers

A Sitagliptin Phosphate supplier is an individual or a company that provides Sitagliptin Phosphate active pharmaceutical ingredient (API) or Sitagliptin Phosphate finished formulations upon request. The Sitagliptin Phosphate suppliers may include Sitagliptin Phosphate API manufacturers, exporters, distributors and traders.

click here to find a list of Sitagliptin Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Sitagliptin Phosphate USDMF

A Sitagliptin Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sitagliptin Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Sitagliptin Phosphate DMFs exist exist since differing nations have different regulations, such as Sitagliptin Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Sitagliptin Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Sitagliptin Phosphate USDMF includes data on Sitagliptin Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sitagliptin Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Sitagliptin Phosphate suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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