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Suppliers and packagers for generic pharmaceutical drug: ACEBUTOLOL HYDROCHLORIDE
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ACEBUTOLOL 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 |
|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharm | ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 075047 | ANDA | AvKARE | 42291-010-01 | 100 CAPSULE in 1 BOTTLE (42291-010-01) | 2023-04-26 |
| Amneal Pharm | ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 075047 | ANDA | AvPAK | 50268-050-15 | 50 BLISTER PACK in 1 BOX (50268-050-15) / 1 CAPSULE in 1 BLISTER PACK (50268-050-11) | 2010-09-16 |
| Amneal Pharm | ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 075047 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-669-01 | 100 CAPSULE in 1 BOTTLE (53746-669-01) | 2009-12-01 |
| Amneal Pharm | ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 075047 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-669-05 | 500 CAPSULE in 1 BOTTLE (53746-669-05) | 2009-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: ACEBUTOLOL HYDROCHLORIDE
ACEBUTOLOL HYDROCHLORIDE Suppliers: Who Makes the API, Intermediates, and Finished Dosage Forms?
ACEBUTOLOL HYDROCHLORIDE is a widely sourced small-molecule beta-blocker. Supplier coverage breaks down into (1) active pharmaceutical ingredient (API) manufacturers, (2) intermediate and raw-material suppliers tied to API production, and (3) finished-dose producers and contract manufacturing organizations (CMOs) that fill capsules or tablets.
ACEBUTOLOL HYDROCHLORIDE supply chain overview
- API production: Typically handled by generic small-molecule API manufacturers in Asia (China/India) and by specialty European or US suppliers for select grades or regulatory dossiers.
- Intermediates: Suppliers often provide key building blocks or selectively reduced/functionalized intermediates used in the API synthetic route.
- Finished dosage forms: Sold as branded and generic tablets/capsules. Some companies own both formulation and distribution; many rely on CMOs for compression, coating, and packaging.
Important note for procurement and risk control: “ACEBUTOLOL” and “acebutolol HCl” are commonly traded under multiple spellings and grade specifications. Purchase documents should require: (a) CEP/DMF/ASMF listing (where applicable), (b) impurity profile alignment, (c) particle size and polymorph form controls where specified, and (d) regulatory traceability by batch.
What companies supply acebutolol hydrochloride API?
Answer (featured snippet): Acebutolol hydrochloride API is supplied through a mix of DMF/ASMF-listed generic API manufacturers and specialty chemical suppliers. The supplier set is not limited to one region; major procurement options usually include multiple tier-1 API vendors with repeat batch production capacity.
API supplier categories buyers typically use
- DMF/ASMF-listed API producers
Vendors that submit or support regulatory filings for acebutolol HCl. - EU GMP grade API suppliers
Used when the target market is the EU/UK and dossier alignment is required. - US/EU qualified secondary suppliers
Provide standardized grades plus QA documentation packages for US importers.
How to screen acebutolol API suppliers
- Regulatory alignment: confirm the vendor supports the required submission type (DMF/ASMF) for your jurisdiction.
- Impurity control: match vendor specification to your internal IPC list for acebutolol HCl.
- Form and salt confirmation: verify the material is acebutolol hydrochloride, not a free-base or alternate salt.
- Analytical package: require CoA plus full test method package (HPLC, water, residual solvents, related substances).
Which suppliers provide acebutolol hydrochloride intermediates and raw materials?
Answer (featured snippet): Intermediates for acebutolol HCl are sourced from chemical manufacturers that produce building blocks and functionalized intermediates for the API route, then sell them as GMP or technical-grade feedstocks depending on customer tier.
Common intermediate sourcing patterns
- Key building blocks: sold by specialty chemical firms under generic intermediate names rather than “acebutolol” branding.
- Functionalization steps: suppliers provide reduced or substituted intermediates with controlled stereochemistry and impurity limits if the upstream process demands it.
- Salt formation support: some vendors sell acebutolol base + HCl salts as a controlled conversion service, not just as a standalone chemical.
Procurement controls for intermediate sourcing
- Ensure upstream synthesis aligns with your downstream impurity targets.
- Lock vendor change control because intermediate impurity drift transfers into API related substances.
What finished dosage-form suppliers manufacture acebutolol hydrochloride tablets or capsules?
Answer (featured snippet): Finished acebutolol products are supplied by branded manufacturers and multiple generic labelers, with many using CMOs for tableting, coating, and packaging.
Manufacturing routes used
- Direct compression tablets for some formulations.
- Granulation + tablet compression for dose uniformity where needed.
- Capsule filling where granular blend flow and dose uniformity support encapsulation.
CME/CMO selection criteria (what matters in practice)
- GMP track record for beta-blockers and controlled-substance handling policies (if applicable in your region).
- Equipment suitability for moisture-sensitive blends and film-coating needs (if applicable).
- Ability to replicate dissolution targets for your formulation strength.
How many acebutolol hydrochloride suppliers exist by region (China, India, EU, US)?
A durable procurement strategy uses at least two API sources and one secondary fallback for scheduling and risk mitigation. In practice, acebutolol HCl tends to be sourced from:
- Asia (China and India): highest number of competitively priced DMF/ASMF-backed API suppliers.
- EU/UK: smaller set, often supplying specific dossier-ready grades.
- US: fewer direct API suppliers; more frequently US firms act as importers/marketers with quality oversight from upstream manufacturers.
What generic entry risks exist for acebutolol hydrochloride that affect supplier availability?
Answer (featured snippet): Generic entry typically increases competition and stabilizes supply in the API market, but supplier availability can tighten when a small number of API producers dominate dossier coverage for certain impurity-control specs.
Risk drivers
- Dossier concentration: if only a handful of suppliers support regulatory submissions, procurement flexibility declines.
- Quality system deviations: API producers can face hold times and batch rejection risk, which impacts finished dose schedule.
- Spec drift: changes in intermediate vendors can alter impurity profiles and trigger regulatory or QA rework.
What regulatory filings (DMF/ASMF/CEP) matter when choosing acebutolol hydrochloride suppliers?
Answer (featured snippet): Buyers normally require evidence that the vendor material is covered by the right regulatory submission format (DMF for US, ASMF/CEP alignment for EU/UK where applicable).
Submission alignment checklist
- US: US DMF reference and suitability for your filing plan.
- EU/UK: ASMF/CEP coverage for acebutolol HCl and suitability for national registration.
- Batch-to-batch consistency: validated impurity range across stability data.
Which companies are challenging acebutolol hydrochloride supply contracts? (manufacturing and compliance issues)
Answer (featured snippet): Supply challenges usually emerge from quality/compliance events, not from “IP challenges” to API manufacturing.
What to monitor
- FDA warning letters or import alert history tied to the vendor’s site (if US-bound).
- Recalls or batch failures for related substances outside spec.
- GMP audit outcomes and CAPA timelines.
- Export documentation quality for traceability.
How does acebutolol hydrochloride compare with similar beta-blocker API sourcing (atenolol, metoprolol, pindolol)?
Answer (featured snippet): Like other generic beta-blockers, acebutolol HCl benefits from multi-vendor sourcing for API. Compared with more complex molecules, it usually has lower manufacturing barrier, which increases supplier count but does not eliminate regulatory dossier gating.
Practical sourcing implication
- Standardized QC packages and impurity spec compliance are the key differentiators.
- Competitive pricing tracks batch availability and dossier coverage rather than purely “API grade” labels.
What supply strategy reduces risk for acebutolol hydrochloride procurement?
Answer (featured snippet): Use a dual-source API program with locked impurity specs and require audit-ready QA documentation from both primary and secondary suppliers, plus one packaging/CMO redundancy plan.
Procurement plan
- Qualify two API suppliers with harmonized specifications.
- Qualify one intermediate/back-up path or secondary API route to handle upstream disruption.
- Lock CoA format and analytical methods to your QC acceptance criteria.
- Maintain at least one local or nearshore packaging option for shorter lead time.
Key Takeaways
- Acebutolol hydrochloride is typically available through a multi-vendor API ecosystem with additional CMO capacity for tablet/capsule manufacturing.
- Procurement should be driven by regulatory dossier alignment, impurity-control compatibility, and batch traceability rather than supplier name alone.
- A two-source API strategy plus packaging/CMO redundancy is the standard approach to avoid schedule risk.
FAQs
- How do I verify acebutolol hydrochloride API is covered by a US DMF for regulatory filing?
- What impurity specifications are typically most sensitive for acebutolol hydrochloride API change control?
- Can acebutolol hydrochloride tablets be reliably sourced from multiple CMOs without dissolution drift?
- What documents should accompany acebutolol hydrochloride API shipments for import and QA release?
- How do I structure a dual-source qualification plan for acebutolol hydrochloride to prevent batch rejection?
References
- U.S. FDA. FDA DMF and regulatory submission resources. (Referenced generally for submission concepts).
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