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API SUPPLIERS
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USDMF
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36545
Submission : 2022-01-03
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
Date of Issue : 2025-10-07
Valid Till : 2028-10-06
Written Confirmation Number : WC-0293
Address of the Firm : 103-106, GIDC Halol, Dist.-Panchmahal, Pin-389350, Gujarat, India
AMI Lifesciences is Driven by Chemistry. Powered by People.
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post Karakhadi, Tal - Padra, Dist. Baroda, Gujara...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
Registrant Name : Hokem Trading Co., Ltd.
Registration Date : 2025-01-14
Registration Number : Su6192-1-ND
Manufacturer Name : Century Pharmaceuticals Limi...
Manufacturer Address : 103 To 106, GIDC, Halol City. - Holol – 389 350 Dist. - Panchmahal, Gujarat State, ...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2020-07-07
Registration Number : Su207-43-ND
Manufacturer Name : Moehs BCN, SL
Manufacturer Address : Polígono Industrial Aquiberia, c/Zenc, 12 08755 Castellbisbal (Barcelona) Spain
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-06-22
Registration Number : Su434-39-ND
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi-391 450, Taluka:Padra, Dist.Vadodara, ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
CAS Number : 702-82-9
End Use API : Vildagliptin
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
(S)-1-(2-Chloroacetyl)pyrrolidine-2-carbonitrile
CAS Number : 207557-35-5
End Use API : Vildagliptin
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Suanfarma, at the Core of a Better Life.
(2S)-1-(Chloroacetyl)-2-Pyrrolidinecarbonitrile
CAS Number : 207557-35-5
End Use API : Vildagliptin
About The Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an i...
Suanfarma, at the Core of a Better Life.
CAS Number : 702-82-9
End Use API : Vildagliptin
About The Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an i...
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CAS Number : 62937-45-5
End Use API : Vildagliptin
About The Company : PMC Isochem, acquired by PMC International in 2017, is a CDMO manufacturing cGMP intermediates, APIs, and functional excipients for global pharmaceutical and pe...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
(2S)-1-(Chloroacetyl)-2-pyrrolidinecarbonitrile
CAS Number : 207557-35-5
End Use API : Vildagliptin
About The Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With fa...
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
CAS Number : 702-82-9
End Use API : Vildagliptin
About The Company : Olpha, a subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in producing medicines and chemical pharmac...
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
CAS Number : 5001-18-3
End Use API : Vildagliptin
About The Company : Olpha, a subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in producing medicines and chemical pharmac...
Oxygenta Pharmaceutical Limited — Powering healthcare through reliable pharmaceuticals and organic fine chemicals
CAS Number : 702-82-9
End Use API : Vildagliptin
About The Company : Oxygenta Pharmaceutical Limited was incorporated as a private limited company in 1990 and later converted into a limited company in 1993. The company was establ...
Oxygenta Pharmaceutical Limited — Powering healthcare through reliable pharmaceuticals and organic fine chemicals
(S)-1-(2-Chloroacetyl)pyrrolidine-2-carbonitrile
CAS Number : 207557-35-5
End Use API : Vildagliptin
About The Company : Oxygenta Pharmaceutical Limited was incorporated as a private limited company in 1990 and later converted into a limited company in 1993. The company was establ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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ABOUT THIS PAGE
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PharmaCompass offers a list of Vildagliptin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Vildagliptin manufacturer or Vildagliptin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vildagliptin manufacturer or Vildagliptin supplier.
A Vildagliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vildagliptin, including repackagers and relabelers. The FDA regulates Vildagliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vildagliptin 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 Vildagliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Vildagliptin supplier is an individual or a company that provides Vildagliptin active pharmaceutical ingredient (API) or Vildagliptin finished formulations upon request. The Vildagliptin suppliers may include Vildagliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Vildagliptin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Vildagliptin DMF (Drug Master File) is a document detailing the whole manufacturing process of Vildagliptin active pharmaceutical ingredient (API) in detail. Different forms of Vildagliptin DMFs exist exist since differing nations have different regulations, such as Vildagliptin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vildagliptin DMF submitted to regulatory agencies in the US is known as a USDMF. Vildagliptin USDMF includes data on Vildagliptin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vildagliptin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vildagliptin suppliers with USDMF on PharmaCompass.
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 Vildagliptin Drug Master File in Japan (Vildagliptin JDMF) empowers Vildagliptin 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 Vildagliptin JDMF during the approval evaluation for pharmaceutical products. At the time of Vildagliptin 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 Vildagliptin suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Vildagliptin Drug Master File in Korea (Vildagliptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vildagliptin. The MFDS reviews the Vildagliptin KDMF as part of the drug registration process and uses the information provided in the Vildagliptin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vildagliptin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Vildagliptin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vildagliptin suppliers with KDMF on PharmaCompass.
A Vildagliptin written confirmation (Vildagliptin WC) is an official document issued by a regulatory agency to a Vildagliptin manufacturer, verifying that the manufacturing facility of a Vildagliptin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vildagliptin APIs or Vildagliptin finished pharmaceutical products to another nation, regulatory agencies frequently require a Vildagliptin WC (written confirmation) as part of the regulatory process.
click here to find a list of Vildagliptin suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Vildagliptin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vildagliptin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Vildagliptin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Vildagliptin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vildagliptin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vildagliptin suppliers with NDC on PharmaCompass.
Vildagliptin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Vildagliptin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Vildagliptin GMP manufacturer or Vildagliptin GMP API supplier for your needs.
A Vildagliptin CoA (Certificate of Analysis) is a formal document that attests to Vildagliptin's compliance with Vildagliptin specifications and serves as a tool for batch-level quality control.
Vildagliptin CoA mostly includes findings from lab analyses of a specific batch. For each Vildagliptin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Vildagliptin may be tested according to a variety of international standards, such as European Pharmacopoeia (Vildagliptin EP), Vildagliptin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vildagliptin USP).
