Product Overview
Vildagliptin is a pharmaceutical active (API) ingredient that is used by drug producers to make medicines for type 2 diabetes.
Vildagliptin is a medication of the class of Dipeptidyl Peptidase-4 (DPP-4) inhibitors.
Vildagliptin API is an intermediate product and not directly used in patients; it must be formulated into finished dosage forms by licensed manufacturers.
It needs to be produced into finished medicine, like tablets, by licensed manufacturers of medicines.
It is given as a white to pale yellowish fine crystalline powder as an API.
It is odorless and stable when preserved under normal conditions.
Vildagliptin controls the body enzymes that influence blood sugar levels.
After being converted into finished medicine, it benefits individuals with type 2 diabetes by stimulating insulin secretion when necessary and reducing the liver’s production of sugar.
It is one of the most reliable DPP-4 inhibitors and boasts an excellent safety track record.
Its API form is in great demand by worldwide pharmaceutical firms.
The API Vildagliptin needs to be of quality and conform to the quality standards dictated by the European Pharmacopoeia (EP), United States Pharmacopoeia (USP), and International Council for Harmonisation (ICH).
The GMP of the API manufacturers also has to be up to par in safety, purity, and uniformity.
Vildagliptin, being a raw material, plays a very important role in providing safe and effective medicines for controlling long-term conditions such as diabetes.
Therapeutic Applications
Vildagliptin API is not directly consumed by patients.
But it needs to go through processing and testing to become a medicine.
But once processed into a final drug, it becomes extremely crucial to the treatment of type 2 diabetes.
The most important benefits of the medicines produced using Vildagliptin are as follows:
Improves Blood Sugar Control
Vildagliptin helps the body to secrete more insulin when blood sugar rises.
It helps reduce postprandial blood sugar.
Reduces Liver Glucose Production
It aids in lowering the liver’s sugar production, maintaining a stable blood sugar level during the day and at night.
Better Tolerability
Drugs formulated using Vildagliptin tend to cause fewer side effects, like weight gain or hypoglycemia, compared to some other antidiabetic medicines.
Used Alone or in Combination
Physicians can prescribe Vildagliptin-based medications alone or in combination with other drugs such as metformin, insulin, or sulfonylureas.
This allows physicians to modify the treatment according to the needs of each patient.
Safe for the Elderly
Vildagliptin-based drugs have been proven to be safe in elderly patients, even those suffering from moderate kidney impairment, when administered under proper medical guidance.
Specification Parameters
Pharmaceutical companies check for all the quality and testing information available when they buy Vildagliptin API.
This enables them to make sure the product is safe and has the necessary performance.
Every batch is tested and has to meet the international quality rules.
The submission may or may not be for Drug Master File (DMF) or Certificate of Suitability (CEP).Key Parameters:
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Appearance: White to off-white crystalline powder
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Molecular Formula: C17H25N3O2
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Molecular Weight: 303.4 g/mol
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Identification: The method used includes IR and HPLC
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Assay (Purity): ≥ 98.0% by HPLC analysis
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Impurities: shall comply with UDL under ICH rules
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Loss on Drying: below 0.5%
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Residue on Ignition: Below 0.1%
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Heavy Metals: Shall be less than 10 ppm
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Microbial Limits: Shall comply with the requirements of the Pharmacopeias
Packaging & Storage
Packaging
Vildagliptin is exported in sturdy and secure packaging to prevent any damage or deterioration during transit and storage.
Double polythene bagged, it is then dispatched in fiber drums of the standard 25 kg size.
Special packing is provided on request by some customers, which includes aluminum-lined HDPE drums or bulk packs.
All the packaging is tamper-evident, and batch numbers, expiry dates, and instructions for use are marked on it.
Storage Conditions
This API should be kept in a dry and cool place and not in the sunlight.
It should be maintained between a temperature of 2°C and to 8°C.
Keep it always in tight closures to protect it from moisture.
Don’t keep it near bases, acids, or heat.
Vildagliptin should be kept in places where only authorized personnel can access.
Shelf Life
If stored appropriately, Vildagliptin is stable for 3 years from the date of its manufacture.
To uphold its quality and effectiveness, the storage provisions have to be followed.
Handling & Transport
Handle Vildagliptin API with care at all times. Put on gloves, masks, and protective clothing.
Do not inhale the dust or allow it to make contact with your skin.
Send the API through trained delivery agents that conform to rules for transporting drug-related material safely and legally.
Why Choose Us
We are a leading supplier of quality Vildagliptin API. We produce our products with global best practice and as high a standard of purity and safety as possible.
1. Consistent High Purity and Quality
Every batch of Vildagliptin is analyzed in well-equipped labs. We supply complete Certificates of Analysis, Drug Master File support, and long-term stability data.
2. Global Approvals
Our API is EU-GMP, US FDA, and WHO-GMP compliant. We help partners get their products registered in various international markets.
3. Competitive Pricing and Reliable Supply
We are capable of offering good products at competitive prices and fast delivery. This is enabled by an organized supply system as well as through high-quality teams.
4. Custom Manufacturing Solutions
We can customise the product to your order, for example, variation in particle sizes or even packaging. We provide flexible API solutions in manufacturing according to custom drugs.
5. Secure Supply Chain
We manage the entire supply process. Our packaging safeguards the API from damage, moisture, and tampering. We care for transportation arrangements with a cold chain when necessary.
6. Technical and Regulatory Support
Our well-read support staff will be able to assist you with everything, from documentation and stability testing to regulatory filings and technical questions.