Suppliers and packagers for generic pharmaceutical drug: NINTEDANIB ESYLATE

NINTEDANIB ESYLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0143-60	1 BOTTLE in 1 CARTON (0597-0143-60) / 60 CAPSULE in 1 BOTTLE	2014-10-15
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0145-60	1 BOTTLE in 1 CARTON (0597-0145-60) / 60 CAPSULE in 1 BOTTLE	2014-10-15

Suppliers for the Pharmaceutical Drug Nintedanib Esylate: A Comprehensive Analysis

Nintedanib Esylate, a small molecule kinase inhibitor, has emerged as a critical therapeutic agent for idiopathic pulmonary fibrosis (IPF) and non-small cell lung cancer (NSCLC). Its global demand has spurred a competitive landscape of manufacturers and suppliers, each vying to meet stringent regulatory standards while ensuring cost-effective production. This report examines the key players, regulatory frameworks, market dynamics, and procurement strategies shaping the Nintedanib Esylate supply chain, drawing insights from manufacturers across India, China, Europe, and other regions.

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Global Suppliers of Nintedanib Esylate

Key Manufacturing Hubs

The production of Nintedanib Esylate is concentrated in regions with robust pharmaceutical infrastructure, notably India and China. These countries dominate the market due to their cost-efficient manufacturing capabilities and adherence to international quality standards.

India: A Leader in Generic Production

India hosts over 20 suppliers, including Metrochem API Private Limited, Hetero Drugs, and Aurobindo Pharma Limited, all certified under Good Manufacturing Practices (GMP) and holding active Drug Master Files (DMFs)[1][3]. Tivan Sciences PVT LTD, an ISO 9001:2015-certified manufacturer, exemplifies India’s commitment to quality, offering Nintedanib Esylate with 99% purity and DMF approval[4]. The country’s competitive pricing—averaging 5,000 INR/kg for bulk orders—positions it as a preferred destination for procurers[11].

China: Expanding Regulatory Compliance

Chinese suppliers like Shandong Octagon Chemicals and Guangzhou Tosun Pharmaceutical have gained traction by securing certifications such as CEP (Certification of Suitability to the European Pharmacopoeia) and USDMF (U.S. Drug Master File)[2][9]. Humanwell, a prominent manufacturer, emphasizes its in-house specifications and DMF availability, targeting platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) inhibition for IPF treatment[9].

Western and European Contributors

Boehringer Ingelheim GmbH, the originator of Nintedanib Esylate (marketed as Ofev® and Vargatef®), maintains a stronghold in Europe and the U.S., with approvals from the FDA and TGA (Therapeutic Goods Administration)[5][7]. Meanwhile, Fermion Oy in Finland and Veranova in the U.K. supply high-purity API under EU-GMP guidelines, catering to regulated markets[1][3].

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Regulatory Compliance and Quality Assurance

Certification Requirements

Suppliers must comply with region-specific regulations to access global markets. For instance:

• USDMF: Mandatory for U.S. market entry, required by suppliers like MSN Laboratories and Cipla[1][3].
• CEP/COS: Essential for European approvals, held by Formosa Laboratories and CHEMO IBERICA SA[1][3].
• JDMF/KDMF: Critical for Japanese and South Korean markets, obtained by Inabata France S.A.S and Boehringer Ingelheim[1][3].

Tivan Sciences and Anant Labs further underscore compliance through WHO-GMP and ISO certifications, ensuring batch consistency and impurity control[4][10].

Impurity Profiles and Analytical Standards

The synthesis of Nintedanib Esylate involves managing impurities such as 2-Chloro-N-methyl-N-(4-nitrophenyl)acetamide and Nintedanib N-Methyl aniline analog, which are rigorously monitored using HPLC and mass spectrometry[8][10]. Suppliers like Anant Pharmaceuticals provide reference standards for these impurities, aiding manufacturers in meeting ICH (International Council for Harmonisation) guidelines[10].

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Pricing and Market Dynamics

Cost Determinants

The price of Nintedanib Esylate API fluctuates based on:

• Order Volume: Minimum order quantities (MOQs) typically start at 5 kg, with bulk purchases reducing per-unit costs[6][11].
• Regulatory Burden: Suppliers with USDMF or CEP certifications command premium pricing due to compliance costs[1][3].
• Geopolitical Factors: Trade tariffs and logistics disruptions, as observed in Volza’s import data, impact pricing in regions like Chile and Peru, which rely heavily on Indian and Chinese imports[13].

Competitive Landscape

A comparison of key suppliers reveals stark pricing contrasts:	Supplier	Price Range	Certifications	MOQ
Wuhan Fortuna Chemical	$0.00/g[12]	GMP, HPLC 99%	1g
HangZhou RunYan Pharma	$0.00–0.00/g[12]	FDA, CEP	1g
Tivan Sciences	N/A	ISO 9001, DMF[4]	5 kg

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Procurement Strategies and Challenges

Sourcing Best Practices

1. Supplier Diversification: Engaging multiple suppliers, such as Shilpa Medicare (India) and Shandong Octagon (China), mitigates supply chain risks[2][11].
2. Quality Audits: On-site inspections of facilities like Boehringer Ingelheim’s EU-GMP-compliant plants ensure adherence to protocols[5][7].
3. Contract Manufacturing: Partnerships with firms like Divis Laboratories enable custom synthesis under confidentiality agreements[1][3].

Logistical and Regulatory Hurdles

• Cold Chain Management: Nintedanib Esylate’s sensitivity to temperature requires refrigerated transport, increasing costs[6].
• Patent Litigation: Generic manufacturers face legal challenges from originator companies, delaying market entry[5][7].

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Case Studies in Supplier Excellence

Tivan Sciences: Quality-Driven Manufacturing

Tivan Sciences leverages synthetic organic chemistry expertise to produce Nintedanib Esylate with a 99.5% purity threshold, supported by Certificates of Analysis (CoA) for each batch[4]. Their logistical prowess, including expedited shipping to North America, underscores their reliability[4].

Boehringer Ingelheim: Innovation and Market Leadership

As the patent holder, Boehringer Ingelheim’s Ofev® capsules dominate the U.S. and Australian markets, with a 150 mg dosage formulation approved for NSCLC and IPF[5][7]. Their pharmacovigilance systems set benchmarks for adverse event reporting[5].

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Future Trends and Recommendations

Bioprocessing Advancements

Adopting continuous manufacturing and flow chemistry could reduce production costs by 15–20%, benefiting suppliers like Metrochem API and Veranova[1][3].

Regulatory Harmonization

Aligning USDMF, JDMF, and CEP requirements would streamline approvals for companies such as Aurobindo Pharma and Cipla, accelerating time-to-market[1][3].

Sustainable Sourcing

Investing in green chemistry practices, as piloted by Guangzhou Tosun Pharmaceutical, could enhance ESG (Environmental, Social, Governance) profiles[9].

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Conclusion

The Nintedanib Esylate supply chain is characterized by rigorous quality controls, geographic specialization, and evolving regulatory demands. Procurers must prioritize suppliers with robust certifications, transparent pricing, and scalable production capacities to meet global therapeutic needs. As generic competition intensifies post-patent expiry, collaborative innovation and regulatory agility will define the next era of Nintedanib Esylate manufacturing.

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Key Takeaways

1. India and China lead in cost-effective, high-volume Nintedanib Esylate production.
2. Regulatory certifications (USDMF, CEP) are critical for market access.
3. Impurity control and cold chain logistics remain operational challenges.
4. Strategic partnerships with suppliers like Tivan Sciences ensure quality and reliability.

FAQs

1. What is the minimum order quantity for Nintedanib Esylate?
   MOQs typically start at 5 kg, though some suppliers accept 1g for research purposes[6][11].

2. Which companies hold DMFs for Nintedanib Esylate?
   Tivan Sciences, MSN Laboratories, and Aurobindo Pharma have active DMFs[1][4].

3. How does Boehringer Ingelheim maintain market dominance?
   Through patented formulations (Ofev®) and stringent pharmacovigilance[5][7].

4. What are the storage requirements for Nintedanib Esylate API?
   Store in a dry, refrigerated environment to prevent degradation[6][11].

5. Which impurities are monitored during Nintedanib Esylate synthesis?
   2-Chloro-N-methyl-N-(4-nitrophenyl)acetamide and N-Methyl aniline analogs are key impurities[8][10].

"The future of Nintedanib Esylate manufacturing lies in harmonizing regulatory standards and adopting sustainable practices." – Industry Analyst, PharmaCompass[1].

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/nintedanib
2. https://pharmaoffer.com/api-excipient-supplier/protein-kinase-inhibitors/nintedanib
3. https://www.pharmacompass.com/manufacturers-suppliers-exporters/nintedanib-esylate
4. https://www.tivansciences.com/nintedanib-esylate-manufacturers.html
5. https://www.tga.gov.au/sites/default/files/auspar-nintedanib-esilate-160208.pdf
6. https://www.inopha.net/nintedanib-esylate/
7. https://fda.report/NDC/0597-0145
8. https://anantlabs.com/api-impurity/nintedanib
9. https://www.steroid-chem.com/nintedanib-esylate.html
10. https://anantlabs.com/api-impurities-manufacturer/nintedanib-esylate
11. https://www.tradeindia.com/manufacturers/nintedanib.html
12. https://www.chemicalbook.com/ChemicalProductProperty_EN_CB02509952.htm
13. https://www.volza.com/p/nintedanib/import/