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Suppliers and packagers for generic pharmaceutical drug: PRAZOSIN HYDROCHLORIDE
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PRAZOSIN HYDROCHLORIDE
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 | MINIPRESS | prazosin hydrochloride | CAPSULE;ORAL | 017442 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-431-85 | 90 CAPSULE in 1 BOTTLE (66993-431-85) | 2021-08-25 |
| Pfizer | MINIPRESS | prazosin hydrochloride | CAPSULE;ORAL | 017442 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-432-85 | 90 CAPSULE in 1 BOTTLE (66993-432-85) | 2022-03-11 |
| Pfizer | MINIPRESS | prazosin hydrochloride | CAPSULE;ORAL | 017442 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-433-85 | 90 CAPSULE in 1 BOTTLE (66993-433-85) | 2022-03-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Prazosin Hydrochloride Suppliers: How to Source API and Finished Drug Products, Vet Quality Systems, and Reduce IP/Regulatory Risk
Who are the main suppliers of prazosin hydrochloride (API) worldwide?
Prazosin hydrochloride is a well-established, off-patent small-molecule antihypertensive. Supply typically splits across (1) API manufacturers that export prazosin hydrochloride as an active ingredient and (2) finished-dose manufacturers that sell tablets into regulated markets.
API supply channels commonly include:
- Indian generic API producers (common for exports and contract supply)
- China-based API manufacturers (often for cost-driven commercial supply and some regulated-market filings)
- Specialty chemical manufacturers that also support intermediates and bulk API
Authoritative supplier identification requires verifying current listings in regulated-market dossiers, inspection status, and quality certifications. Without that document-level verification, any named “API supplier list” risks being inaccurate or outdated.
Which companies manufacture prazosin hydrochloride tablets in the US and EU?
Finished-dose supply depends on country-specific marketing authorizations, distributor agreements, and generic portfolio shifts.
In practice, prazosin hydrochloride tablets are commonly marketed by:
- US generic manufacturers with ANDA approvals
- EU MA holders that include generic tablet brands and parallel distributors
A defensible, company-specific “who sells what” list requires pulling:
- FDA Orange Book entries (ANDA holders and listed strengths/manufacturers)
- EMA national/central authorization records
- Lot-level distributor mapping for each market
No market-verified dataset is provided here, so company names cannot be stated with the accuracy expected for sourcing, regulatory, and litigation decisions.
What are the typical prazosin hydrochloride dosage forms and strengths supplied by vendors?
Commercial supply is generally tablet-based.
Common strengths (market-dependent):
- 0.5 mg
- 1 mg
- 2 mg
- 5 mg
Vendor packaging formats vary by market and contract terms:
- Bottles for retail distribution
- Bulk packs for wholesalers
- Strips/blisters where required by the national market
How do you qualify a prazosin hydrochloride API supplier for regulated markets?
Qualification is a quality-system and documentation exercise, not a marketing exercise. For regulated manufacturing, most buyers require the following before approving prazosin hydrochloride API:
API quality documentation that buyers usually require
- Certificate of Analysis (CoA) per lot
- Spec sheet aligned with pharmacopeial or internal targets
- DMF/ASMF status (if held) or dossier cross-reference for regulator review
- GMP compliance evidence (facility inspection status)
- Impurity profile and change control history
- Stability data for assigned retest period
- Traceability and serialization readiness (if applicable)
Risk checks specific to a generic, small-molecule API
- Variability in process impurities
- Lot-to-lot nitrosamine risk control screening and control strategy (if applicable under current guidance)
- Supply continuity risk from single-plant dependence
What regulatory filings determine which prazosin hydrochloride suppliers can enter the US?
For the US, sourcing viability is constrained by two systems:
- API-facing dossiers (DMF/ASMF) and inspection outcomes
- Finished-dose approvals through FDA Orange Book-listed ANDAs for prazosin hydrochloride tablets
A buyer assessing supplier eligibility normally cross-checks:
- Whether the supplier’s API is referenced in an approved drug substance filing
- Whether the drug product manufacturer is compliant for the intended market
- Whether any listed patents affect launch timing (less relevant to sourcing, but critical for licensing and procurement tied to a launch)
What contract manufacturing (CDMO) options exist for prazosin hydrochloride tablets?
CDMOs typically offer:
- Formulation development to tablet specs
- Manufacturing under cGMP
- Packaging and labeling for specific markets
CDO selection is driven by:
- Experience with antihypertensive tablet manufacturability
- Analytical capability (dissolution, assay, impurity)
- Ability to meet country-specific labeling and stability requirements
- Timelines for tech transfer and validation
A named CDMO roster cannot be produced here without a market-verified listing dataset.
How do you compare prazosin hydrochloride suppliers on price, lead time, and quality?
A procurement scoring model usually uses:
- Total landed cost (API or finished product) including freight, import duties, and excise
- Lead time (manufacture + release + shipping + customs clearance)
- Quality maturity (inspection history, deviation rate, responsiveness)
- Supply resilience (capacity redundancy and second-source availability)
- Regulatory responsiveness (ability to support changes and documentation requests quickly)
What IP, patent, and Orange Book factors affect procurement and sourcing decisions?
For procurement, the direct driver is usually finished product availability, not IP ownership. However, IP status matters when:
- A buyer is launching a generic or branded product
- A distributor contract depends on launch timing
- There are known Paragraph IV disputes affecting supply continuity
Accurate prazosin hydrochloride patent estate mapping requires Orange Book and litigation record retrieval. No such dataset is included here, so no specific patent numbers, assignees, or expiration dates can be stated.
Are biosimilar or biologic supply pathways relevant to prazosin hydrochloride?
No. Prazosin hydrochloride is a small-molecule chemical API. Biosimilar frameworks do not apply.
What generic entry risks exist for prazosin hydrochloride, and can they disrupt supply?
Generic entry risks can disrupt supply through:
- Litigation-driven manufacturing delays
- Settlement-driven supply agreements
- Regulatory holdbacks from quality or labeling deficiencies
Any supplier-specific risk analysis requires current litigation and regulatory history.
Key Takeaways
- Prazosin hydrochloride supply is dominated by generic API and tablet manufacturers, with regulated-market entry determined by quality systems, dossier support, and FDA/EMA approvals.
- A reliable supplier list requires Orange Book and dossier-level verification plus current GMP and inspection evidence.
- Qualification should focus on lot-level CoAs, impurity control, stability, documentation traceability, and inspection outcomes.
- IP and litigation can affect finished product availability even when the API market appears competitive, so launch-linked procurement should include current regulatory and Orange Book checks.
FAQs
What documents should a prazosin hydrochloride API supplier provide before qualification?
CoA, specs, impurity profile, stability data, DMF/ASMF status (if applicable), GMP evidence, and change control history.
Can prazosin hydrochloride tablets be sourced internationally if the US market prefers specific ANDA holders?
Yes, but market entry depends on regulatory authorization, distribution compliance, and labeling requirements in each jurisdiction.
What quality tests matter most for prazosin hydrochloride API and tablets?
Assay/potency, impurity profile, dissolution (for tablets), residual solvents/reagents (process-dependent), and stability-indicating tests.
Does prazosin hydrochloride require special nitrosamine control screening?
Buyers typically require a nitrosamine risk control statement aligned with current regulatory expectations for small-molecule APIs where applicable.
How can a buyer avoid supply interruptions when sourcing prazosin hydrochloride?
Use dual sourcing, contract manufacturing capacity checks, and require documented continuity and batch release timelines.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. Drug Master Files (DMFs). https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-master-files-dmfs
- EMA. Guidelines and quality requirements for medicines manufacturing and control. https://www.ema.europa.eu/en/medicines
- ICH. Q-series guidelines (Quality). https://www.ich.org/page/quality-guidelines
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