Suppliers and packagers for LOPID

LOPID

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422	NDA	Parke-Davis Div of Pfizer Inc	0071-0737-20	60 TABLET, FILM COATED in 1 BOTTLE (0071-0737-20)	2004-03-30
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422	NDA	Parke-Davis Div of Pfizer Inc	0071-0737-30	500 TABLET, FILM COATED in 1 BOTTLE (0071-0737-30)	2004-03-30
Pfizer Pharms	LOPID	gemfibrozil	TABLET;ORAL	018422	NDA	Parke-Davis Div of Pfizer Inc	0071-0737-20	60 TABLET, FILM COATED in 1 BOTTLE (0071-0737-20)	2004-03-30
Pfizer Pharms	LOPID	gemfibrozil	TABLET;ORAL	018422	NDA	Parke-Davis Div of Pfizer Inc	0071-0737-30	500 TABLET, FILM COATED in 1 BOTTLE (0071-0737-30)	2004-03-30

LOPID (gemfibrozil): Supplier Landscape for Key Inputs and Manufacturing Supply Chain

Last updated: April 26, 2026

Who makes the active ingredient for LOPID (gemfibrozil)?

LOPID’s active pharmaceutical ingredient (API) is gemfibrozil. Public patent and regulatory records used in standard drug supply-chain mapping do not provide a single, static list of API suppliers for every marketed label, packager, and strength over time. The most decision-relevant view for procurement and risk planning is the regulatory-linked supply chain: firms that manufacture gemfibrozil under current compliance frameworks, typically identified through FDA drug establishment and application-linked manufacturing site disclosures and foreign manufacturing authorizations used by NDA/ANDA owners.

Procurement implication: treat “API supplier for LOPID” as a multi-site, time-varying network rather than one vendor. For due diligence, the authoritative starting point is the FDA’s drug establishment registrations and label-linked manufacturing site information, cross-referenced to the product’s NDA/ANDA listing for the relevant dosage form and strength.

Which contract manufacturing categories support LOPID?

Even with one brand product, the operational supply chain typically breaks into four vendor classes:

1. API manufacturer: manufactures gemfibrozil (or supplies it as bulk drug substance).
2. Formulation and drug product manufacturer: manufactures the tablets (or capsules, if applicable in the market).
3. Packaging supplier: supplies bottles/blisters, desiccants, closures, and cartons.
4. Quality and compliance partners: analytical labs for release testing and stability management (often integrated with the drug product site).

LOPID’s commercial supply network usually involves at least:

• one drug product site that holds the manufacturing authorization for the solid oral dosage form, and
• one or more API sites supplying bulk drug substance.

How do you identify the correct suppliers for LOPID in practice?

For business-grade supplier selection and IP-aware diligence, the practical method is to anchor on regulatory site disclosures and then map outward to commercial suppliers:

1) Map FDA-registered manufacturing establishments

Use the FDA drug establishment registration (DESI) database and match:

• registered establishment names
• addresses in the U.S. (if relevant for distribution)
• drug product or API manufacturing categories

This yields a defensible list of candidate manufacturers for LOPID’s manufacturing steps.

2) Map NDA product listing to manufacturing sites

Then use the product’s application and label-linked data to determine which registered establishments actually manufacture the specific dosage strength and dosage form that corresponds to LOPID packaging in the U.S.

3) Validate with quality agreements and site master files

Procurement should require:

• CoA and BMR/BPR references
• DMF/EDMF or supplier qualification documentation (as applicable)
• stability and release testing method cross-walks

What supplier types typically exist for gemfibrozil API (drug substance)?

Gemfibrozil API supply commonly comes from international and regional chemical/pharma API manufacturers. For supplier identification, diligence focuses on:

• compliance status (GMP, FDA inspections history, remediation plans if any)
• process capability (particle size control is less central for API than for final blend, but polymorph and impurity profile control matter)
• impurity specification adherence (API impurity profile impacts downstream formulation stability and regulatory release testing)
• supply continuity (batch release cadence and raw material availability)

What are the key manufacturing steps that create “vendor leverage” for LOPID?

For LOPID tablets, the vendor leverage usually sits in:

• Blend uniformity and compression performance at the tablet site
• tablet dissolution and stability performance (formulation process control)
• analytical release testing capacity (HPLC/UV methods, impurity quantification)
• packaging integrity (moisture control, container closure system)

Procurement risk increases if:

• the drug product site relies on a single API source with limited safety stock, or
• the packaging configuration changes across market requirements without a robust change-control record.

Which companies are commonly involved with LOPID supply?

Without using external regulatory lookups in this session, it is not possible to produce a complete and accurate list of specific supplier company names that manufacture gemfibrozil API and LOPID drug product under the current label and market requirements. In high-stakes procurement, supplying unverified vendor names is a material failure mode.

Actionable alternative for decision-making: build a vendor shortlist strictly from FDA site registrations and label-linked manufacturing disclosure for LOPID’s active strength, dosage form, and packaging configuration, then qualify those sites through quality documentation and manufacturing authorization checks.

Key supplier diligence checklist for LOPID (gemfibrozil)

Use this to screen and contract suppliers once regulatory-linked candidates are identified:

API (gemfibrozil) supplier qualification

• GMP compliance and inspection status (API manufacturing)
• DMF/EDMF linkage (where applicable)
• impurity and residual solvent control ranges
• batch size and release lead time
• change control history for synthesis and purification steps

Drug product (tablet) manufacturer qualification

• tablet manufacturing line validation (compression performance)
• dissolution method qualification and transfer history
• stability program coverage (accelerated and long-term)
• release testing personnel and lab qualification
• packaging line capability (closure and carton configurations)

Packaging supplier qualification

• moisture barrier specification compliance
• compatibility with tablets (container closure integrity)
• labeling and serialization readiness (where required by market rules)
• supply continuity and spare capacity

Key Takeaways

• LOPID’s supplier universe is not a single fixed vendor list; it is a multi-site regulatory-linked supply chain spanning gemfibrozil API and solid oral drug product manufacturing, plus packaging.
• The procurement-grade approach is to identify suppliers through FDA drug establishment registration and label-linked manufacturing site disclosures, then validate via quality agreements and documentation.
• Supplier leverage for LOPID is concentrated in API supply continuity, tablet dissolution and compression process control, and release testing capacity.

FAQs

1. Is there one permanent API supplier for LOPID (gemfibrozil)?
   No. API supply is typically multi-site and can change with commercial and compliance needs.

2. What is the most reliable way to list LOPID manufacturing suppliers?
   Regulatory site-linked disclosures (FDA establishment registrations and label/manufacturing site associations) are the most reliable basis for identifying manufacturing firms.

3. What suppliers matter most for LOPID risk management?
   The gemfibrozil API manufacturer and the drug product tablet manufacturer typically drive supply risk and quality variability; packaging integrity is the next key control.

4. What diligence documents should procurement require from API suppliers?
   GMP status, impurity specifications, CoA/batch release history, and change-control documentation tied to the supplier qualification package.

5. Does packaging supplier selection affect regulatory release for LOPID?
   It can. Container closure systems affect stability and moisture exposure, which can influence release and shelf-life outcomes.

References

[1] U.S. Food and Drug Administration. Drug Establishment Registration and Drug Listing Resources. APA style citation format for FDA database resources.