Atorvastatin API Manufacturer & Supplier India
GMP-Certified · API Exporter India · Surat, Gujarat
HMG-CoA reductase inhibitor API used to lower cholesterol and reduce cardiovascular risk. Request a quotation for bulk Atorvastatin supply to regulated global markets.
Atorvastatin Product Overview
Vubrix Pharma is a trusted global manufacturer and supplier of Atorvastatin Calcium Trihydrate API. Dedicated to cardiovascular health, we provide pharmaceutical companies worldwide with premium-grade Atorvastatin that strictly conforms to USP, EP, and BP pharmacopeial standards, supported by comprehensive regulatory documentation.
Atorvastatin (supplied primarily as Atorvastatin Calcium Trihydrate, CAS No: 344423-98-9) is a statin medication widely prescribed to lower blood cholesterol levels and prevent cardiovascular events.
Chemical Name: Calcium (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate trihydrate. Appearance: White to off-white crystalline powder.
Applications
- Hypercholesterolemia: Highly effective in lowering elevated total cholesterol, LDL-C, apolipoprotein B, and triglycerides.
- Cardiovascular Disease Prevention: Reduces the risk of myocardial infarction, stroke, and revascularization procedures in patients with multiple risk factors.
- Dyslipidemia: Used to elevate HDL-C ('good cholesterol') levels.
Technical Specifications
- Purity: NLT 98.0% - 102.0% (on an anhydrous basis).
- Impurity Profile: Extremely stringent controls, strictly adhering to ICH guidelines. Nitrosamine-free testing guaranteed.
- Documentation: CoA, MOA, MSDS, and Open Part DMF available.
Manufacturing Process
Mechanism of Action: Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for converting 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.
Vubrix Pharma ensures the highest levels of purity and safety, manufacturing Atorvastatin in WHO-GMP certified facilities with rigorous controls to prevent polymorphic transformation.
Learn more about our manufacturing capabilities and quality assurance systems.
Packaging Information
Standard Packaging: 25 Kg double polyethylene bags housed in secure fiber drums.
Storage Information
Storage Conditions: Store in a well-closed container, protected from light and moisture, at controlled room temperature.
Quality Standards
Our API is strictly tested to be free from unacceptable levels of nitrosamines (NDMA/NDEA). We guarantee superior crystalline stability for robust formulation.
Export Markets
We are a preferred supplier for large-scale formulation units across North America, the EU, the Middle East, and Latin America, ensuring seamless customs clearance and regulatory compliance.
Why Choose Vubrix Pharma
With deep expertise in statin manufacturing, Vubrix Pharma offers unmatched purity, full DMF support, and competitive pricing for generic pharmaceutical manufacturers globally.
- Therapeutic class: Statin
- End application: Dyslipidemia and cardiovascular risk reduction
Frequently Asked Questions about Atorvastatin
What is Atorvastatin API used for?
It is the active ingredient used to manufacture medications that lower cholesterol and prevent cardiovascular diseases.
Which salt form of Atorvastatin do you supply?
We primarily supply Atorvastatin Calcium Trihydrate, known for its excellent stability.
Is your Atorvastatin API WHO-GMP certified?
Yes, our API is manufactured in state-of-the-art WHO-GMP certified facilities.
What pharmacopeias does your Atorvastatin comply with?
Our Atorvastatin complies with USP, EP, and BP standards.
What is the CAS number for Atorvastatin Calcium Trihydrate?
The CAS number is 344423-98-9.
Is a Drug Master File (DMF) available?
Yes, an open part DMF is available to support your regulatory filings.
Do you test for Nitrosamine impurities?
Absolutely. We have rigorous testing protocols to ensure our Atorvastatin is free from unacceptable levels of nitrosamines.
What is the minimum order quantity (MOQ)?
Our standard MOQ is 25 kg, packed in fiber drums.
How is the API packaged for export?
It is packed in double PE bags inside robust 25 kg fiber drums to protect from moisture and light.
How does Atorvastatin differ from Rosuvastatin?
Both are statins, but they have different pharmacokinetic profiles, half-lives, and potencies, though both effectively lower LDL cholesterol.
Do you export to the European Union?
Yes, we actively export to the EU and comply with necessary regulatory requirements.
Can Vubrix Pharma manufacture finished Atorvastatin tablets?
Yes, we offer contract manufacturing for finished Atorvastatin formulations (10mg, 20mg, 40mg, 80mg).
What is the shelf life of Atorvastatin Calcium Trihydrate?
The standard shelf life is 36 months when stored under recommended conditions.
Is Atorvastatin soluble in water?
It is very slightly soluble in distilled water, but soluble in methanol.
How do you ensure polymorphic stability?
Our controlled crystallization processes ensure consistent production of the desired crystalline form, preventing polymorphic transformation.
Can I receive a sample for laboratory evaluation?
Yes, commercial samples and CoAs can be provided to verified B2B buyers.
What are the storage requirements?
Store in a cool, dry place, protected from direct sunlight and moisture.
How long does bulk shipping take?
Lead times depend on destination, typically 2-4 weeks.
What payment terms are accepted?
We accept standard international trade terms like TT and LC at sight.
Who do I contact for a bulk quotation?
Please use the inquiry form on this page or contact our export sales team via WhatsApp.
Request a Quote for Atorvastatin
Get pricing, MOQ, lead time, and documentation for Atorvastatin. Our team responds within 24 hours.