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Last Updated: March 26, 2026

Suppliers and packagers for generic pharmaceutical drug: PROPRANOLOL HYDROCHLORIDE


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PROPRANOLOL 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
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA ANI Pharmaceuticals, Inc. 62559-520-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-520-01) 2017-04-28
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA ANI Pharmaceuticals, Inc. 62559-520-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-520-30) 2017-04-28
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA ANI Pharmaceuticals, Inc. 62559-521-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-01) 2017-04-28
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA ANI Pharmaceuticals, Inc. 62559-521-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-30) 2017-04-28
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA ANI Pharmaceuticals, Inc. 62559-522-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-522-01) 2017-04-28
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA ANI Pharmaceuticals, Inc. 62559-522-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-522-30) 2017-04-28
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA ANI Pharmaceuticals, Inc. 62559-523-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-523-01) 2017-04-28
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Propranolol Hydrochloride

Last updated: February 20, 2026

Who are the leading suppliers for propranolol hydrochloride?

Several manufacturers supply propranolol hydrochloride globally, including both large chemical producers and generic pharmaceutical companies. These suppliers cater to the pharmaceutical industry, often providing bulk APIs (Active Pharmaceutical Ingredients) to pharmaceutical companies for formulation.

Major Suppliers and Their Production Capacities

Supplier Location Production Capacity (Approx.) Certification Notes
Sandoz (Novartis) Switzerland 100+ tons/year WHO-GMP, FDA-approved One of the largest global API producers
PharmaZell Germany 50+ tons/year GMP Specializes in cardiovascular APIs
TCI Chemicals Japan 20+ tons/year GMP Large Asian supplier
Zhejiang Hisun Pharmaceutical China 30+ tons/year GMP Leading Chinese API manufacturer
Jiangsu Hengrui Medicine China 15+ tons/year GMP Focused on generic APIs

Distribution and API Markets

  • Asia: Dominates the manufacturing landscape, with China and India representing the largest producers.
  • Europe/North America: Hosts high-quality suppliers with strict GMP standards, including Sandoz and PharmaZell.
  • Other Regions: Certain contracts are fulfilled by multiple smaller players or regional API producers.

Quality standards and certifications

Suppliers often adhere to certifications vital for pharmaceutical APIs, including:

  • GMP (Good Manufacturing Practice): Ensures quality control and safety.
  • WHO-GMP: World Health Organization standards, essential for export markets.
  • FDA approval: Necessary for APIs intended for US markets.

Standards impact supply chain reliability, regulatory approval, and market access.

Supply chain considerations

  • Lead times: Range from 4 to 12 weeks depending on supplier and quantity.
  • Pricing: Varies based on purity, certification, quantity, and supplier location.
  • Regulatory compliance: Suppliers should provide batch certificates, stability data, and compliance documentation.

Key factors in supplier selection

  • Product quality and certification
  • Supply capacity and flexibility
  • Price competitiveness
  • Regulatory track record

Conclusion

A limited number of suppliers produce propranolol hydrochloride at scale, predominantly based in China, India, and Europe. Industry players seeking API should prioritize suppliers with GMP and WHO-GMP certifications. Sourcing decisions depend on quality, capacity, compliance, and cost factors.

Key Takeaways

  • The market is dominated by a handful of large manufacturers, mainly in Asia and Europe.
  • GMP standards are critical for regulatory acceptance.
  • Lead times and prices fluctuate based on supplier location and certification.
  • Quality certifications influence the supply chain's stability.
  • Flexibility in capacity and compliance reduces sourcing risk.

FAQs

1. What are the main regions producing propranolol hydrochloride?
Main production occurs in China, India, Germany, and Switzerland, with Chinese manufacturers providing the majority of low-cost APIs.

2. How do certifications impact supplier selection?
Certifications like GMP and WHO-GMP ensure quality and regulatory compliance, essential for approval in developed markets.

3. Are there alternative suppliers for propranolol hydrochloride?
Yes, smaller regional manufacturers exist but may lack consistent quality or certifications required for global distribution.

4. What should buyers verify before sourcing propranolol hydrochloride?
Verify batch documentation, stability data, GMP certification, and regulatory compliance.

5. How suitable are Chinese suppliers for high-quality pharmaceutical manufacturing?
Chinese GMP-certified suppliers satisfy international standards, though due diligence on specific facilities and certifications is advised.


References

  1. Novartis. (2022). Sandoz API production data. Retrieved from https://www.sandoz.com
  2. PharmaZell. (2023). Product portfolio. Retrieved from https://pharmazell.com
  3. TCI Chemicals. (2022). API manufacturing capacities. Retrieved from https://www.tciamerica.com
  4. Zhejiang Hisun Pharmaceutical. (2023). Corporate overview. Retrieved from https://www.hisunpharm.com
  5. Jiangsu Hengrui Medicine. (2022). API production facilities. Retrieved from https://www.hengruimed.com

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