Last updated: June 1, 2026
BETAPACE is a brand of sotalol, a beta-blocker/antiarrhythmic. In supply-chain and procurement terms, the supplier universe splits into (1) US drug product manufacturers tied to FDA approvals and label manufacturing, and (2) active pharmaceutical ingredient (API) sources tied to DMFs and supply contracts. Without the specific strength (Betapace 80 mg vs 120 mg) and dosage form (tablets) you’re buying, a complete, verifiable supplier list cannot be produced from authoritative records.
What companies supply BETAPACE (sotalol) tablets in the US market?
Answer: Supplier identification for BETAPACE in the US requires mapping the FDA label’s “Manufactured for / Manufactured by” information and the currently listed “Applicant/Manufacturer” on the relevant NDA in FDA’s Drugs@FDA and the Orange Book. That mapping is not available in the input provided.
Which strength and label-tracked supplier should procurement use?
- BETAPACE is marketed in tablet strengths that may have different manufacturing sites depending on NDA labeling updates.
- Procurement due diligence typically anchors on:
- the strength-specific prescribing label manufacturing statement
- the Orange Book listing for that strength
- any FDA “Manufacturing Site” history tied to CMC supplements
How do you verify the supplier via FDA records?
- Step-level verification is done through:
- Orange Book “Drug Product” manufacturer listing per strength
- the NDA/BLA holder and “Dosage Form/Strength” entries
- Drugs@FDA label “Manufactured for / by” lines and any listed contract manufacturers
Who supplies the BETAPACE API (sotalol) sourced from DMFs?
Answer: API suppliers are identified through the DMF reference in the NDA and through third-party API manufacturing disclosures tied to FDA submissions. A supplier list cannot be produced from the input provided.
What determines which API suppliers can lawfully feed BETAPACE?
- DMF ownership and cross-reference status
- eligibility for NDA incorporation by reference
- API specifications (particle size, polymorph form, residuals)
- supply chain qualification and validation status
- global regulatory clearance for the specific DMF and manufacturing site
Do API sources differ by country or by tablet strength?
- The same API site can feed multiple strengths.
- Strength-specific packaging or tablet manufacturing sites may differ even if the API comes from a single source.
Which manufacturers hold the BETAPACE NDA and control the supply chain?
Answer: The NDA holder controls label-level product supply through contract manufacturing and quality agreements, but the NDA holder name and currently listed manufacturing sites are not provided in the input.
What procurement artifacts typically list BETAPACE manufacturing sites?
- FDA label manufacturing statements
- Orange Book drug product records
- Quality agreements referenced in batch release and GMP documentation
What does the Orange Book listing show for BETAPACE suppliers?
Answer: Orange Book listings show the drug product entry and its listed sponsor/manufacturer per strength, plus patent and exclusivity status. Those listing fields are not present in the input provided.
Why Orange Book is the fastest supplier validation route
- It is strength-specific.
- It ties to the FDA-approved drug product entry.
- It is the reference point for generic and authorized distribution due diligence.
Which companies produce BETAPACE generics versus the brand?
Answer: Generic entrants and ANDA suppliers are not specified in the input. Without the Orange Book ANDA landscape for sotalol corresponding to BETAPACE, a supplier roster cannot be completed.
How generic competition affects supplier availability
- A given API supplier can serve multiple ANDAs.
- But the market “supplier” for procurement usually means the labeled drug product manufacturer or authorized distributor, not the upstream API producer.
What supplier network exists for sotalol in injectable antiarrhythmic segments?
Answer: BETAPACE is tablets. Any injectable “sotalol” segment involves different products, likely different NDAs, and potentially different suppliers. The input is not specific to any injectable version.
Are there multiple sotalol products with different supplier ecosystems?
- Yes. Oral sotalol tablets and any other dosage forms for sotalol are typically tied to separate label and manufacturing records.
Key Takeaways
- A complete, verifiable BETAPACE supplier list requires strength-specific FDA label and Orange Book manufacturing-sponsor data plus any DMF-referenced API sourcing disclosures.
- The input provided does not include those FDA-record fields, so a full supplier roster cannot be produced.
FAQs
- How do I identify the correct BETAPACE tablet manufacturer for a specific strength (80 mg vs 120 mg) using FDA records?
- Where in Drugs@FDA or the Orange Book do I find the “drug product” manufacturing site for BETAPACE?
- How are sotalol API suppliers tied to BETAPACE through DMFs and what does “DMF reference” mean in practice?
- Do BETAPACE manufacturing sites change after CMC supplements, and how is that reflected on the label?
- If I buy BETAPACE through wholesalers, how do I confirm which manufacturer produced the specific lots?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA. Drugs@FDA. U.S. Food and Drug Administration.
