Get a snapshot of Atorvastatin’s global DMF filings, certification types, and sourcing insights using publicly available Chemxpert Database. Atorvastatin isn’t new. But it still dominates.
Doctors write over 115 million prescriptions for it every year. That’s not just demand—it’s market gravity. Since Lipitor’s patent expired, generics have taken over. Fast approvals depend on data.
Enter the Drug Master File, the quiet MVP of regulatory filings. A DMF tells regulators how the API is made, tested, and stored. It’s not public, but it’s powerful. Type II DMFs are the standard for APIs. They prove quality, consistency, and GMP compliance without revealing proprietary secrets to your competitors.
For Atorvastatin Calcium, there are now 25+ active USDMFs. Many come with CEP, WHO-GMP, or local filings in Canada, Japan, and India. That’s not overkill. That’s strategy. Regulators rely on DMFs. So do procurement teams. Picking a supplier with an approved DMF cuts risk and speeds up filings.
Drug master file, or DMF in short is a technical blueprint that describes the making, testing and storage of an API.
Specifically, Type II DMFs are the gold standard for APIs. They contain vital data about the drug’s chemistry, manufacturing process, and controls (CMC), all of which are reviewed by regulatory agencies to ensure safety and quality.
Why does this matter? Because behind every generic drug approval lies a web of trusted data. Regulatory bodies like the FDA or EMA don’t just take a manufacturer’s word—they rely on these DMFs to validate that the API being used meets strict compliance and quality standards.
For pharma procurement teams and regulatory officers, DMFs are more than paperwork—they’re the backbone of sourcing strategy. Choosing a supplier with an active, accepted DMF can reduce approval risks, accelerate filings, and streamline compliance across borders.
In a fragmented supply chain, regulatory clarity is a competitive edge.
Pro Insight: Chemxpert Database lets you scan global DMF filings at a glance, giving teams the foresight to pick qualified, compliant sources faster.
Atorvastatin is not just another API—it’s one of the top-selling cholesterol-lowering drugs worldwide. Originally developed under the brand name Lipitor, it continues to be a staple in cardiovascular care even after its patent expiry.
Given its therapeutic value and market size, atorvastatin is heavily regulated. Manufacturers looking to supply this API in global markets must comply with multiple regulatory frameworks.
This leads to extensive filings to gain market access and build trust with buyers and regulators.
Common regulatory filings for atorvastatin include:
As of today, there are 25+ active USDMFs, and numerous CEP and WHO-GMP certified listings for atorvastatin calcium.
Unlike niche APIs, atorvastatin sees high competition among manufacturers. To stand out and ensure regional access, suppliers often pursue multiple certifications. This means a single manufacturer may hold:
This creates a web of filings, each tailored to the regulations of target markets.
For pharma procurement and compliance teams, this regulatory density has both benefits and challenges:
Benefits:
Challenges:
While DMFs indicate a manufacturer’s capability to supply raw API, FDF (Finished Dosage Form) filings tell a broader story, one of market presence, commercial scale, and therapeutic reach. Atorvastatin, a leadin g lipid-lowering agent, shows an expansive global footprint based on its FDF registration data.
Chemxpert’s database reveals the following breakdown of Atorvastatin FDF filings by continent:
|
Region |
Number of FDF Filings |
|
North America |
493 |
|
South America |
1376 |
|
Africa |
434 |
|
Asia |
2644 |
|
Europe |
1530 |
This data paints a clear picture: Atorvastatin is not only heavily regulated, it’s widely commercialized. Asia leads in formulation filings, reflecting its manufacturing and generics-driven economies. Europe and South America follow closely, with strong adoption across both regulated and semi-regulated markets.
FDF filings are critical indicators of:
For R&D and regulatory teams, tracking where finished formulations are filed can inform everything from patent strategy to market expansion plans.
Want to see the country-by-country bifurcation of these filings?
Click here to explore the full listing on Atorvastatin Data Summary:
Atorvastatin Calcium is a cornerstone in the global fight against high cholesterol and cardiovascular disease.
As a blockbuster statin, its widespread use in generic drug formulations makes regulatory documentation, particularly the Drug Master File, a critical asset for manufacturers, regulators, and procurement teams alike.
DMFs serve as confidential submissions to regulatory bodies like the U.S. FDA, offering a complete profile of the API’s safety, quality, and manufacturing process. Below, we explore the essential elements that make up a Type II DMF for Atorvastatin Calcium.
Every DMF begins with the basics:
This section sets the groundwork, helping regulators quickly identify the scope of the filing and the responsible entity.
Facilities and Equipment
This part demonstrates the manufacturer’s ability to produce Atorvastatin under GMP conditions:
Regulators use this to verify that the production environment meets international quality benchmarks.
Quality control protocols help regulators trust the repeatability and reliability of the manufacturing process:
Without this section, regulatory authorities cannot confirm the robustness of the quality assurance program.
How an API is handled post-manufacture directly impacts its shelf life and performance:
Packaging data also influences transport, import/export approvals, and final formulation.
Pharma runs on precision. Speed helps, but trust wins. That’s where Drug Master Files (DMFs) quietly become your most strategic sourcing asset.
Atorvastatin Calcium isn’t just a popular API, it’s a blueprint for regulatory clarity done right. Multiple certifications, global filings, and wide usage make it a go-to for both buyers and regulators.
Every active DMF tells a story:
Procurement teams gain leverage. Regulatory officers reduce risk. Commercial timelines speed up. All by choosing the right supplier—backed by an approved, current DMF.
So here’s the mindset shift:
Don’t just chase price. Follow the filings.
Smart sourcing starts with good data. Global platforms like Chemxpert make that easier than ever.
You don’t need more meetings. You need better visibility.
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