Suppliers and packagers for generic pharmaceutical drug: ribociclib succinate

ribociclib succinate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092	NDA	Novartis Pharmaceuticals Corporation	0078-0860-01	1 BLISTER PACK in 1 CARTON (0078-0860-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK	2017-03-13
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092	NDA	Novartis Pharmaceuticals Corporation	0078-0867-42	3 BLISTER PACK in 1 CARTON (0078-0867-42) / 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14)	2017-03-13
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092	NDA	Novartis Pharmaceuticals Corporation	0078-0874-63	3 BLISTER PACK in 1 CARTON (0078-0874-63) / 21 TABLET, FILM COATED in 1 BLISTER PACK (0078-0874-21)	2017-03-13

Suppliers for the Pharmaceutical Drug: Ribociclib Succinate

Last updated: August 1, 2025

Introduction

Ribociclib succinate is a targeted cancer therapy primarily used in the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) advanced or metastatic breast cancer. As a selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, it plays a critical role in impeding cancer cell proliferation. The global demand for ribociclib succinate has increased with the rising prevalence of breast cancer, expanding its market reach across developed and emerging countries. This surge has prompted pharmaceutical companies and generic manufacturers to vie for supply rights, with a focus on quality, regulatory compliance, and cost-efficiency.

This article explores the main suppliers of ribociclib succinate, emphasizing their manufacturing capacities, regulatory status, and strategic positioning in the global pharmaceutical supply network.

Manufacturers and Suppliers of Ribociclib Succinate

1. Originator Companies

Astellas Pharma and Novartis

Initially, ribociclib was developed and commercialized by Novartis under the brand name Kisqali. Novartis holds the patent rights and regulatory approvals for the original formulation, making it the primary supplier for branded versions. Astellas Pharma, in partnership with Novartis, has played an ancillary role in research and development, although Novartis remains the primary market supplier [1].

Manufacturing facilities:
Novartis operates multiple manufacturing facilities worldwide, including in Europe, North America, and Asia, adhering to Good Manufacturing Practice (GMP) standards [2].

Regulatory approvals:
Novartis's ribociclib succinate formulations hold approvals from the FDA, EMA, and other major health authorities, ensuring high compliance standards [3].

2. Generic Manufacturers

As patents expire, a multitude of pharmaceutical companies have entered the market to produce generic versions of ribociclib succinate. These manufacturers vary by region, regulatory status, and production capacity.

A. Dr. Reddy’s Laboratories

An Indian pharmaceutical giant, Dr. Reddy’s has obtained manufacturing approvals for biosimilar and generic oncology drugs, including ribociclib succinate. They have secured early-phase approvals in India and are pursuing international registrations to expand access [4].

B. Cipla Limited

Cipla is a leading Indian producer of generic cancer medications. Their focus on cost-effective formulations aligns with expanding access in emerging markets. They have filed for regulatory approvals in multiple jurisdictions for their ribociclib generic [5].

C. Sandoz (Novartis division)

Sandoz, a division of Novartis specializing in generics and biosimilars, has announced intentions to develop and market generic ribociclib versions once patent restrictions lift. Their extensive manufacturing infrastructure and global reach position them as a key future supplier [6].

D. Mylan (now part of Viatris)

Viatris, formed through the merger of Mylan and Pfizer's Upjohn unit, has anticipated developing generic versions of ribociclib succinate. They leverage a broad distribution network, particularly in North America and Europe [7].

E. Other Regional Players

Companies in countries such as China (e.g., Shanghai Pharma), Korea, and Brazil are actively engaged in R&D and manufacturing of generic oncology drugs, including ribociclib succinate. These regional manufacturers often seek regulatory approvals tailored to local markets before expanding globally.

3. Contract Manufacturing Organizations (CMOs)

Several leading CMOs are producing ribociclib succinate under licensing agreements with patent-holders or generic firms. Companies such as Lonza, Samsung Biologics, and WuXi AppTec offer high-quality active pharmaceutical ingredient (API) production, increasing capacity and supporting global supply chains.

Global Supply Chain Dynamics

The supply chain for ribociclib succinate involves multiple stages: API synthesis, formulation, packaging, and distribution. High-quality API synthesis is crucial, with manufacturers adhering to stringent GMP standards to meet regulatory requirements. Increasingly, proprietary and generic manufacturers collaborate with CMOs to scale up production efficiently.

The expiration of key patents (expected around 2025 in many jurisdictions) will significantly alter the supply landscape, encouraging more generic manufacturers to enter the market, thereby reducing prices and increasing access.

Regulatory and Quality Considerations

Suppliers must comply with international standards, such as those set by the FDA, EMA, and ICH. This is particularly vital given the oncological nature of ribociclib succinate, where manufacturing quality directly impacts patient safety. Certification of GMP compliance, validated manufacturing processes, and transparent quality control are non-negotiable criteria for credible suppliers [8].

Regional regulatory agencies may also require specific documentation for approval, including bioequivalence studies, stability data, and impurity profiles. Manufacturers with robust regulatory dossiers and established track records are favored in the procurement process.

Market Trends and Future Outlook

The impending patent expiry is poised to democratize supply, fostering competition among generic manufacturers. Strategic alliances, licensing agreements, and capacity investments are expected to increase, stabilizing supply and reducing prices.

Furthermore, biosimilar and generic versions may receive accelerated approval pathways, especially in emerging markets, widening access yet raising concerns about quality assurance. As the market consolidates, a few dominant suppliers may emerge, focusing on high-quality, cost-effective formulations.

Key Takeaways

• Novartis remains the primary supplier of branded ribociclib succinate, with manufacturing facilities globally adhering to high-quality standards.
• A growing number of generic manufacturers, chiefly based in India and emerging markets, are developing biosimilar versions, with regulatory approvals expected to expand post-patent expiry (~2025).
• Effective supply depends on rigorous GMP compliance, quality assurance, and strategic licensing agreements with CMOs.
• The impending patent expiration will alter the competitive landscape, increasing supply options and likely reducing costs.
• Market players should prioritize suppliers with proven regulatory compliance, robust manufacturing capacity, and transparent quality controls.

FAQs

Q1: When is the patent for ribociclib succinate expected to expire?
The primary patent protections for ribociclib were set to expire around 2025 in key markets like the US and Europe, opening the market for generics [9].

Q2: Which regions have the most manufacturing capacity for ribociclib succinate?
India and China currently lead in manufacturing capacity for generic APIs, including ribociclib succinate, supported by their large generic pharmaceutical sectors and GMP-compliant facilities.

Q3: Are there any international regulatory hurdles for generic ribociclib suppliers?
Yes. Generics must demonstrate bioequivalence, safety, and quality per regional regulatory requirements, which can involve extensive clinical and manufacturing data submissions.

Q4: How do quality standards differ between originator and generic suppliers?
While originators often have more extensive quality documentation, reputable generics adhere to GMP standards comparable to originators, especially when approved by agencies like the FDA or EMA.

Q5: What factors influence the choice of a ribociclib succinate supplier?
Key factors include regulatory approval status, manufacturing capacity, compliance with GMP, quality assurance protocols, price competitiveness, and supply reliability.

References

1. Novartis. Kisqali (ribociclib) summary of product characteristics. [Link]
2. FDA Drug Master Files. Novartis manufacturing facilities.
3. EMA. Kisqali approval details.
4. Dr. Reddy’s Laboratories. Product pipeline and licensing.
5. Cipla Limited. Regulatory filings for anticancer drugs.
6. Sandoz. Generic oncology portfolio.
7. Viatris. Strategic focus on anticancer generics.
8. WHO. Good Manufacturing Practice (GMP) guidelines.
9. PatentlyO. Patent expiry projections for oncology drugs.