Suppliers and packagers for LOVASTATIN

LOVASTATIN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Carlsbad	LOVASTATIN	lovastatin	TABLET;ORAL	075991	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-548-14	14 TABLET in 1 BOTTLE, PLASTIC (43063-548-14)	2002-11-25
Carlsbad	LOVASTATIN	lovastatin	TABLET;ORAL	075991	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-548-30	30 TABLET in 1 BOTTLE, PLASTIC (43063-548-30)	2002-11-25
Carlsbad	LOVASTATIN	lovastatin	TABLET;ORAL	075991	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-548-90	90 TABLET in 1 BOTTLE, PLASTIC (43063-548-90)	2002-11-25
Carlsbad	LOVASTATIN	lovastatin	TABLET;ORAL	075991	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-548-93	180 TABLET in 1 BOTTLE, PLASTIC (43063-548-93)	2002-11-25

Suppliers and packagers for LOVASTATIN

Last updated: May 25, 2026

Lovastatin Suppliers: APIs, Manufacturers, Contract Development and Manufacturing (CDMO) Coverage, and Sourcing Risks

Lovastatin supply chains typically split into (1) API and key intermediates and (2) finished-dose tablet manufacturing. The most decision-relevant “suppliers” for procurement, licensing, or risk management are API manufacturers/holders, intermediate producers, and finished-dose contract manufacturers that can support strength-specific tablets (often 10 mg, 20 mg, 40 mg) and compliant small-batch or scale-up production.

Who manufactures lovastatin API and intermediate chemicals?

Lovastatin is generally produced via multi-step chemical synthesis beginning from defined precursors that drive the lactone construction and stereochemical steps. In practice, procurement focuses less on “generic supplier names” and more on FDA-registered facilities manufacturing lovastatin API or controlled intermediates under cGMP.

API supplier categories that matter for sourcing

• API manufacturers that produce lovastatin as a drug substance for downstream tablet sites.
• Intermediate and key intermediate suppliers that support the API route (often controlled by DMF status or supplier qualification).
• Finished-dose tablet manufacturers that buy API and handle formulation, blending, compression, film coating, packaging, and release testing.

What to check in supplier due diligence

• Whether the supplier holds an FDA Drug Master File (DMF) tied to lovastatin (API manufacturing and impurity profiles).
• Whether the supplier’s sites appear in FDA facility listings for drug substances and/or products.
• Whether the supplier can support required regulatory filings (DMF, CMC section inputs, CoA language, stability protocols).
• Whether the supplier can meet impurity limits and deliver consistent polymorph and particle size distributions (critical for bioavailability in statin tablets).

Which companies supply lovastatin tablets (finished dosage forms) to the US market?

Finished-dose lovastatin tablet supply is usually concentrated among established generics and specialty CDMOs that can run hard tablet lines with validated dissolution and bioequivalence-ready specs.

Manufacturing footprints that typically supply tablets

• US-based ANDA product manufacturers that package and release lovastatin tablets.
• CDMOs that run tablet compression and coating lines for multiple strengths using an approved API source.
• Packaging suppliers for blister and bottle formats aligned to US distribution.

Quality and supply-chain signals for tablet manufacturers

• Consistent lot-to-lot dissolution profiles aligned with label-level specs.
• Validation that coating and tablet hardness control moisture uptake and impurity formation (relevant for statin lactones).
• Capability to support short lead times for strength variations (10/20/40 mg).

How does lovastatin supplier selection affect FDA approval and regulatory filings?

Supplier selection impacts CMC sections, bioequivalence strategy, and impurity controls. For generics, it also affects what can be supported through reliance on an approved DMF or master manufacturing protocol.

Key CMC linkage points

• API DMF reference and letter of authorization status (directly affects what an ANDA can cite).
• Impurity profile comparability (regulatory scrutiny increases if impurity drift occurs during sourcing transitions).
• Stability program design (accelerated and long-term) tied to the specific supplier’s API grade and polymorph behavior.

Common risk points

• Changing API suppliers during product registration or scale-up can force additional data and can trigger regulatory friction if impurity and dissolution comparability are not demonstrated.
• Intermediate supplier changes can affect residual solvents, stereochemical purity, and lactone hydrolysis behavior.

What is the Orange Book status of lovastatin, and how does that constrain sourcing?

Lovastatin is a long-established statin and is widely genericized in the US. For sourcing, the practical constraint is not usually “remaining exclusivity,” but product-level regulatory lock-in tied to specific labeled strengths, dosage forms, and approved formulations.

How Orange Book status affects supply decisions

• If lovastatin products are generics, new entrants can source from any compliant API supplier, subject to regulatory comparability and facility suitability.
• If any brand or protected product has listed patents or exclusivities, it can constrain launching competing NDA/ANDA strategies, but it usually does not restrict API procurement itself.

When do lovastatin generics lose exclusivity, and does supplier choice change launch timing?

Launch timing is driven by product-specific patent and exclusivity clocks, not by API sourcing alone. A supplier swap does not change the legal expiration calendar but can delay launch if CMC comparability work becomes necessary.

Operational timeline dependencies

• Qualification of a new API supplier typically needs release testing alignment, impurity trending, and sometimes additional stability sampling.
• If an ANDA depends on DMF content from a particular manufacturer, timing depends on receiving and maintaining DMF authorization.

Are there Paragraph IV risks for lovastatin, and do they affect supplier strategy?

Paragraph IV risks relate to patent challenges tied to marketed product patents, not to whether an API supplier exists. Supplier strategy becomes relevant if a challenge requires maintaining product comparability without triggering additional data demands.

What procurement teams typically do in a Paragraph IV context

• Lock the API supplier early to maintain consistent impurity profiles and dissolution performance.
• Ensure CMC documentation can be replicated across manufacturing lots using the approved supplier’s specification set.

What formulation patents protect lovastatin tablets, and do they limit which suppliers can be used?

Formulation protection, where it exists, generally covers excipients, coating systems, tablet design, and controlled dissolution strategies. For lovastatin, where generics dominate, formulation differentiation is often limited to meeting dissolution specs rather than proprietary formulation structures.

Where formulation constraints can show up

• Proprietary coating formulations used to control moisture uptake and impurity formation.
• Specific blending granulation methods that maintain dissolution.
• Use of particular excipient grades or particle size targets that materially affect dissolution.

How does lovastatin compare with other statins for sourcing complexity?

Lovastatin is often compared commercially and medically with other statins such as atorvastatin, simvastatin, and pravastatin, but sourcing complexity depends on chemistry route stability, DMF coverage, and local manufacturing capacity.

Procurement implications vs other statins

• Some statins show higher sourcing concentration due to fewer API manufacturing lines.
• Lovastatin, as a mature generic, generally has more multi-sourcing options, but impurity control and cGMP stability programs remain decisive.

What manufacturing/IP barriers can block a new lovastatin supplier?

The barriers tend to be regulatory and process-knowledge barriers rather than discrete IP prohibitions.

Barriers that show up in practice

• Tight impurity specification and validated analytics that require method transfer.
• Validated process conditions tied to lactone integrity and impurity formation pathways.
• DMF dependence: if an ANDA references a specific DMF, an alternative supplier may not be plug-and-play.

Supplier qualification checklist for lovastatin (API and tablets)

API supplier qualification

• Verify DMF status and authorization coverage.
• Confirm impurity limits, residual solvents, and stereochemical purity spec.
• Run comparative analysis for dissolution-relevant properties (if product is sensitive).
• Confirm particle size range and polymorph behavior consistency.
• Validate shipping, storage conditions, and packaging that limit moisture and heat exposure.

Tablet manufacturer qualification

• Confirm validated tablet hardness, disintegration, and dissolution profiles by strength.
• Confirm coating and packaging capability for the intended market (bottles vs blister).
• Require batch record review for critical process parameters that drive dissolution.
• Confirm stability and data generation capacity for launch and lifecycle updates.

Key Takeaways

• Lovastatin sourcing is a two-layer procurement problem: API/DMF-aligned supply plus finished-dose tablet manufacturing qualification.
• Regulatory constraints mostly show up through DMF linkage, impurity profile comparability, and CMC data requirements rather than through general “supplier exclusivity.”
• Launch timelines are impacted by supplier qualification and CMC comparability work, not by supply availability alone.
• Supplier due diligence should prioritize DMF status, impurity and dissolution comparability, and validated manufacturing consistency across lots.

FAQs

1) What does DMF coverage mean for lovastatin API sourcing?
It determines whether an ANDA can cite the API manufacturing information legally and whether the product can rely on the supplier’s controlled impurity and process documentation.

2) Can a finished-dose tablet manufacturer change lovastatin API suppliers without regulatory impact?
Often not without CMC work. Changes can require comparability studies, stability updates, and documentation updates.

3) What impurity controls matter most for lovastatin API?
Controls focus on residual solvents, hydrolysis-related impurities, and consistent impurity profiles tied to the manufacturing route and storage.

4) How do lovastatin tablet dissolution specs affect CDMO selection?
CDMOs must demonstrate validated dissolution performance by strength and coating conditions since statin tablets can be sensitive to moisture and processing parameters.

5) Do supplier changes affect patent litigation risk for lovastatin?
They usually do not change the legal merits of a patent case, but inconsistent API sourcing can complicate product comparability arguments and CMC consistency during challenge or settlement implementation.

References (APA)

1. US Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. US Food and Drug Administration. (n.d.). Drug Master Files (DMF). https://www.accessdata.fda.gov/scripts/cder/dmf/