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List of Drug Master Files (JDMF) for Janumet Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 F. I. S. Fabrica Italiana Sintetici S. p. A. (2)

02 Honor Lab Limited (1)

03 MSD International GMBH (Puerto Rico Branch) LLC (1)

04 MSD International GmbH (Singapore Branch) (50 Tuas) (2)

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01 Sitagliptin Phosphate (1)

02 Sitagliptin phosphate hydrate (3)

03 Sitagliptin phosphate hydrate (contains propyl gallate) (2)

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01 India (1)

02 Italy (2)

03 Singapore (3)

URL Supplier Web Content
305MF10116
Viale Milano 26 36075 Montecchio Ma...
2023-10-12
2023-10-12
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226MF10001
Viale Milano 26 36075 Montecchio Ma...
2014-01-08
2014-01-08
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303MF10124
H. No. &8-3-166/7/1, Erragadda, Hyd...
2021-08-16
2021-08-16
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220MF10082
Road 183, Pridco Industrial Park, L...
2009-05-13
2008-03-18
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231MF10016
50 Tuas West Drive Singapore 638408
2019-01-23
2019-01-23
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305MF10105
50 Tuas West Drive Singapore 638408
2023-08-30
2023-08-30
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Looking for 1269630-53-6 / Sitagliptin Phosphate API manufacturers, exporters & distributors?

Sitagliptin Phosphate manufacturers, exporters & distributors 1

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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.

Janumet Manufacturers

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

Janumet Suppliers

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

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

Janumet JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Janumet Drug Master File in Japan (Janumet JDMF) empowers Janumet API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Janumet JDMF during the approval evaluation for pharmaceutical products. At the time of Janumet JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Janumet suppliers with JDMF on PharmaCompass.

Janumet Manufacturers | Traders | Suppliers

Janumet Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Janumet

Get in contact with the supplier of your choice:

  1. F.I.S. Fabbrica Italiana Sintetici
  2. HONOUR LAB LTD
  3. MSD INTL GMBH
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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