TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glenmark Pharms Ltd	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-294-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-01)	2015-02-25
Glenmark Pharms Ltd	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-294-10	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-10)	2015-02-25
Glenmark Pharms Ltd	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-294-90	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-90)	2015-02-25
Glenmark Pharms Ltd	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-295-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-295-01)	2015-02-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 3, 2026

Suppliers for Trandolapril and Verapamil Hydrochloride (API and Finished Dosage): Who Manufactures Supply and Where the Risk Concentrates

Key points: Trandolapril and verapamil hydrochloride are off-patent small-molecule cardiovascular drugs with a broad supplier base for both active pharmaceutical ingredient (API) and finished dosage forms. API supply is concentrated among multi-product generic API producers in China and India, with additional coverage from Europe for higher-compliance markets. Finished-dose sourcing typically tracks supplier filings and FDA approvals for U.S. market products, while quality risk is driven by regulatory inspections, ANDA/BLA conformity to cGMP, and impurity control for each API.

Who supplies the Trandolapril API for generic and branded manufacturing?

Answer: Trandolapril API supply is dominated by international generic API manufacturers that produce ACE-inhibitor APIs under cGMP, with U.S. distribution tied to ANDA applicants and contract API procurement.

Common API supplier profile for trandolapril

Production geography: India and China account for most global API manufacturing capacity for off-patent ACE inhibitors.
Customer type: ANDA holders, generic finished-dose firms, and CDMO-integrators for tablet manufacture.
Regulatory hook: API suppliers usually qualify through customer audits and supplier qualification packages aligned to ICH Q7 and cGMP expectations.

Typical supply chain mapping (API to finished dosage)

API manufacturers supply trandolapril API to:
- ANDA applicants that formulate and tablet or capsule manufacture under their own quality systems, or
- CDMOs that perform formulation and manufacturing for multiple ANDA applicants.

Supply risk for trandolapril

Impurity control (process-related impurities and degradation products) drives supplier selection.
Inspection outcomes and warning-letter history shape who can reliably serve major customers.
Raw material access affects lead times for ACE inhibitor intermediates.

Who supplies verapamil hydrochloride API and how does it differ from trandolapril supply?

Answer: Verapamil hydrochloride API is supplied by a larger number of qualified producers than trandolapril because verapamil is an older, widely used calcium channel blocker with more dosage-form variants worldwide.

API supply characteristics for verapamil hydrochloride

More market depth: Verapamil has multiple oral presentations (immediate release and extended release), which widens the supplier base and manufacturing specialization.
Higher formulation diversity: Some supply chains revolve around controlled-release excipient systems, changing which manufacturers are considered “qualified” at the finished-dose level even when the same API supplier is used.
Demand variability: Verapamil’s long-running utilization can make supply steadier but also increases competitive pressure among API producers.

Supply risk for verapamil hydrochloride

Polymorph and impurity profile control matters more for release-form stability.
Batch-to-batch consistency is a key qualification gate for sustained-release tablet/capsule lines.
Stability and dissolution behavior link API quality to performance in extended release products.

Which companies supply finished-dose tablets or capsules containing trandolapril and verapamil hydrochloride?

Answer: Finished-dose sourcing for each active ingredient is handled by generic manufacturers with FDA-approved ANDAs and by branded manufacturers where applicable. The supplier lineup changes by:

dosage form (tablet strength vs. extended release),
whether the product is single-ingredient or combination,
and whether the product is marketed as branded or generic.

How finished-dose supplier coverage is typically structured

U.S. market: Finished-dose suppliers are ANDA holders and branded labelers listed in FDA product databases.
International markets: Local wholesalers source from national distributors tied to the country’s registration holders.

What matters for contracting a finished-dose supplier

FDA approval status (for U.S. procurement)
cGMP compliance record and facility inspection posture
bioequivalence requirements for generics
change-control history affecting formulation and process

Do trandolapril and verapamil hydrochloride have the same supply base, or separate supplier ecosystems?

Answer: They run separate supplier ecosystems at the procurement level even when API supply overlaps among multi-product API manufacturers.

Why procurement ecosystems differ

Different therapeutic classes and impurity control targets
Different downstream dosing forms
Different stability and release performance requirements (especially if verapamil extended release is involved)

Implication for sourcing

A procurement strategy that bundles both actives with one supplier is feasible only when the supplier has validated production for both APIs and the finished-dose manufacturer’s quality system can absorb both.

How many API suppliers exist for trandolapril and verapamil hydrochloride, and what does the concentration look like?

Answer: The market typically shows many API producers worldwide for both drugs, but supplier concentration at the qualified-customer level depends on:

validated impurity ranges,
audit history,
and ability to provide consistent CoA and DMF-linked documentation.

Concentration drivers

DMF availability (where used in customer qualification)
Inspection outcomes
Controlled manufacturing slots at the API plant

Procurement reality

Even with many producers globally, only a smaller fraction become “active qualified suppliers” for large finished-dose manufacturers after audit and performance verification.

What is the regulatory status of trandolapril and verapamil hydrochloride that affects sourcing in the U.S.?

Answer: Sourcing in the U.S. depends on FDA-recognized drug product approvals for finished dosage forms and cGMP-compliant API supply used in those approvals.

How FDA status affects supplier qualification

Finished-dose products must be manufactured under FDA-compliant systems.
API suppliers feed into customer quality systems through:
- CoAs,
- audit reports,
- specification packages,
- change-control notifications,
- and, when applicable, DMF linkages.

Practical sourcing gates

Ability to support regulatory submissions with documentation
Stability data and impurity specifications aligned to the finished-dose dossier
Controlled packaging and shipping conditions to preserve quality

Are there known FDA enforcement trends that change which suppliers can sell these APIs?

Answer: Enforcement posture tends to cluster around:

quality systems,
facility sanitation and cross-contamination risk,
impurity control and spec compliance,
data integrity.

Effect on sourcing

Warning letters and EIR findings can remove suppliers from consideration quickly, even if their product is chemically standard.
Large customers maintain pre-approved supplier lists and remove suppliers after regulatory events.

What generic entry risks exist for trandolapril and verapamil hydrochloride suppliers?

Answer: Generic entry risks are mainly commercial and compliance-related, not chemical novelty.

Main risks that affect supply contracts

Failure to maintain bioequivalence after formulation changes
Failure to hold impurity specs due to raw material variability
Shortages caused by production-line constraints or regulatory actions

How this impacts sourcing

Customers prefer suppliers with demonstrated batch consistency and regulatory-resilient operations.

How do sourcing and qualification requirements differ between APIs and finished-dose drug products?

Answer: API qualification is documentation-heavy and spec-focused; finished-dose qualification is documentation plus performance-focused.

API qualification

impurity profiling and limits
residual solvents and elemental impurities compliance
CoA credibility and traceability
manufacturing process validation evidence

Finished-dose qualification

bioequivalence evidence (for generics)
dissolution and stability for release profiles
labeling accuracy and packaging controls
continued compliance with ANDA commitments

Which dosage forms matter most for verapamil hydrochloride supplier selection?

Answer: Supplier selection differs by release profile.

Key dosage-form split

Immediate-release verapamil: focuses on API stability and standard tablet performance.
Extended-release verapamil: increases scrutiny on dissolution performance, excipient compatibility, and manufacturing process controls.

Do CDMOs affect who can supply trandolapril and verapamil hydrochloride?

Answer: Yes. CDMO manufacturing lines can concentrate demand among a subset of API suppliers that can meet CDMO technical and documentation standards.

CDMO-driven impacts

CDMOs often require API technical packages up front.
Some CDMOs favor suppliers with DMF-ready documentation or with a history of supplying multiple customers.

Key Takeaways

Trandolapril and verapamil hydrochloride are widely supplied by off-patent API manufacturers, with supplier ecosystems that can differ materially at the qualified-customer level despite overlap among global generic API producers.
Verapamil hydrochloride generally has a deeper supplier base due to multiple dosage forms, especially extended release, which tightens finished-dose qualification.
U.S. procurement hinges on FDA-recognized approved finished dosage products and cGMP-compliant API supply, with supplier qualification driven by impurity control, batch consistency, and inspection posture.
The practical supplier shortlist is smaller than the global supplier count, because audits and performance verification remove most candidates.

FAQs

1) Can the same API supplier provide both trandolapril and verapamil hydrochloride to the same finished-dose manufacturer?

Yes, but only if the supplier has validated impurity control, consistent batch performance, and documentation support that passes the manufacturer’s audit and regulatory quality review.

2) What documentation is typically required for API supplier qualification for these cardiovascular drugs?

CoA, impurity/specifications, manufacturing process and validation evidence, change-control approach, traceability, and alignment to cGMP/ICH Q7 expectations as embedded in the customer’s quality system.

3) What drives shortages more often: API suppliers or finished-dose manufacturers?

Finished-dose line constraints and regulatory actions affecting manufacturing continuity are common drivers, even when API supply exists.

4) Does extended-release verapamil increase technical sourcing complexity?

Yes. It increases scrutiny on dissolution, stability, excipient compatibility, and process controls that translate API variation into performance differences.

5) How do API supplier changes affect finished-dose product approval status?

Changes can trigger comparability assessments, regulatory notifications, and in some cases require bridging studies depending on the scope and risk tier of changes under the applicable regulatory framework and the customer’s submission commitments.

References

No sources cited because no specific supplier list, FDA Orange Book entries, DMF-linked supplier names, facility identifiers, or product-level filings were provided in the prompt.