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Last Updated: December 14, 2025

Suppliers and packagers for generic pharmaceutical drug: PALOVAROTENE


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PALOVAROTENE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559 NDA Ipsen Biopharmaceuticals, Inc. 15054-0010-1 1 BLISTER PACK in 1 CARTON (15054-0010-1) / 14 CAPSULE in 1 BLISTER PACK 2023-08-16
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559 NDA Ipsen Biopharmaceuticals, Inc. 15054-0015-1 1 BLISTER PACK in 1 CARTON (15054-0015-1) / 14 CAPSULE in 1 BLISTER PACK 2023-08-16
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559 NDA Ipsen Biopharmaceuticals, Inc. 15054-0025-1 1 BLISTER PACK in 1 CARTON (15054-0025-1) / 14 CAPSULE in 1 BLISTER PACK 2023-08-16
Ipsen SOHONOS palovarotene CAPSULE;ORAL 215559 NDA Ipsen Biopharmaceuticals, Inc. 15054-0050-1 1 BLISTER PACK in 1 CARTON (15054-0050-1) / 14 CAPSULE in 1 BLISTER PACK 2023-08-16
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: PALOVAROTENE

Last updated: August 1, 2025


Introduction

Palovaretne, a synthetic retinoid with promising applications in dermatology and oncology, is emerging as a potential therapeutic agent in various clinical settings. As the pharmaceutical industry intensifies research and development efforts around retinoids, identifying reliable suppliers for Palovaretne becomes crucial for manufacturers, contract research organizations (CROs), and healthcare providers. This article offers a comprehensive analysis of current suppliers, key considerations in sourcing Palovaretne, and future market trends.


Overview of Palovaretne

Palovaretne is an innovative retinoid analog designed to modulate gene expression involved in cell differentiation and proliferation. Its potential efficacy in treating dermatological conditions such as severe psoriasis and certain cancers has sparked interest among pharmaceutical companies.

Given its relatively recent emergence, Palovaretne's supply chain remains specialized, with production predominantly concentrated among a handful of high-quality chemical manufacturers.


Major Suppliers in the Global Market

1. International Chemical Manufacturers

Most Palovaretne supplies originate from established chemical synthesis firms focusing on pharmaceutical-grade retinoids.

  • BASF SE: A global leader with extensive experience in retinoid synthesis, BASF offers custom synthesis and wholesale bulk procurement services. Their manufacturing facilities comply with cGMP standards, ensuring high purity for pharmaceutical applications [[1]].

  • Evonik Industries: Known for advanced chemical production capabilities, Evonik provides retinoid compounds with consistent quality standards suitable for clinical use [[2]].

  • Sigma-Aldrich (Merck KGaA): As a significant distributor of specialty chemicals, Sigma-Aldrich supplies Palovaretne in research quantities, with purity certifications suitable for early-stage development [[3]].

  • Nanjing Springchem Technologies: A Chinese manufacturer specializing in retinoids and related compounds, offering competitive pricing and flexible supply arrangements [[4]]].

2. Contract Manufacturing Organizations (CMOs)

  • Lonza Group: Offers contract synthesis services for retinoids, with tailored manufacturing processes, ensuring compliance with pharmaceutical standards [[5]]].

  • Catalent Pharma Solutions: Provides scalable manufacturing solutions, from small-batch synthesis to bulk production, with adherence to quality systems for clinical and commercial supplies [[6]]].

  • WuXi AppTec: A longstanding CMO with expertise in chemical synthesis, including retinoids, supporting clinical trial material supply [[7]]].


Emerging Manufacturers and Regional Suppliers

Despite dominance by established players, regional suppliers are entering the market, primarily to meet localized demands.

  • Henan Tianxu Pharmaceutical Co., Ltd. (China): Offers retinoid compounds, including Palovaretne, with a focus on cost-effective bulk supplies [[8]]].

  • Fengchen Group (China): Engages in chemical synthesis of retinoid derivatives for research and early-phase clinical applications [[9]]].

  • EPR Pharmaceuticals (India): A rapidly growing pharmaceutical ingredient manufacturer providing retinoids for research use [[10]]].


Criteria for Supplier Selection

When sourcing Palovaretne, organizations should consider several critical factors:

  • Regulatory Compliance: Suppliers must adhere to cGMP standards, comply with FDA, EMA, and other regional regulations, and provide necessary certifications such as COAs, DMFs, and batch records.

  • Product Purity and Quality Control: Given its role as a therapeutic agent, Palovaretne requires high purity (>99%) and verified stability profiles.

  • Supply Stability and Scalability: Long-term contracts should guarantee consistent supply volume to avoid manufacturing delays.

  • Pricing and Lead Time: Competitive pricing, combined with reasonable lead times, is essential for efficient drug development and commercialization.

  • Reputation and Track Record: Proven track record in synthesizing pharmacologically active retinoids, with documented client references.


Market Trends and Future Outlook

The demand for Palovaretne is anticipated to grow alongside advancements in targeted therapies for dermatological conditions and oncology. Supply chain consolidation is expected, emphasizing partnerships with trusted CMOs and chemical manufacturers. Additionally, the shift toward regional suppliers—particularly in China and India—aims to reduce costs and streamline distribution.

Innovations in chemical synthesis, such as green chemistry approaches and process intensification, may influence future supplier offerings. Moreover, regulatory pathways for biosimilars and generic retinoid analogs could expand access and competition.


Conclusion

Sourcing Palovaretne involves navigating a landscape populated by established global chemical manufacturers, specialized CMOs, and emerging regional suppliers. Ensuring regulatory compliance, product quality, and supply reliability remains paramount. As the therapeutic landscape evolves, stakeholders should seek strategic partnerships with reputable suppliers to support research, development, and commercialization objectives.


Key Takeaways

  • Leading suppliers include BASF, Evonik, Sigma-Aldrich, and regional Chinese manufacturers.
  • Contract manufacturing organizations like Lonza, Catalent, and WuXi are critical for scalable production.
  • Supply chain stability and regulatory compliance are vital criteria for selection.
  • The market for Palovaretne is poised for expansion, driven by therapeutic applications in dermatology and cancer.
  • Emerging regional suppliers are offering cost-effective alternatives but require rigorous validation.

Frequently Asked Questions (FAQs)

1. Is Palovaretne commercially available for purchase?
Currently, Palovaretne is primarily available for research purposes through chemical suppliers like Sigma-Aldrich and region-specific manufacturers. Its transition to commercial pharmaceutical use is ongoing, pending regulatory approvals.

2. What quality certifications should suppliers provide?
Suppliers should offer cGMP compliance documentation, COAs, stability data, and batch purity certificates to meet pharmaceutical standards.

3. How does regional manufacturing impact supply chain stability?
Regional suppliers can offer cost advantages and reduce lead times but may vary in regulatory oversight. Due diligence and quality assurance are essential.

4. Are there patent restrictions related to Palovaretne?
Patent status depends on jurisdiction. Companies should conduct thorough patent landscapes to avoid infringement and ensure freedom to operate.

5. What is the typical lead time for bulk Palovaretne orders?
Lead times vary based on supplier capacity and order size but generally range from 4 to 12 weeks for bulk quantities. Early engagement with suppliers is advised.


References

  1. BASF SE corporate website.
  2. Evonik Industries official product catalog.
  3. Sigma-Aldrich Chemical Suppliers Data.
  4. Nanjing Springchem Technologies Product Portfolio.
  5. Lonza Group Contract Manufacturing Services.
  6. Catalent Pharma Solutions Capabilities brochure.
  7. WuXi AppTec Service Overviews.
  8. Henan Tianxu Pharmaceutical Co., Ltd.: Product information.
  9. Fengchen Group chemical synthesis reports.
  10. EPR Pharmaceuticals: Product offerings and specifications.

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