Suppliers and packagers for JANUVIA

JANUVIA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995	NDA	Merck Sharp & Dohme LLC	0006-0112-28	100 BLISTER PACK in 1 CARTON (0006-0112-28) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0112-01)	2006-10-16
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995	NDA	Merck Sharp & Dohme LLC	0006-0112-31	30 TABLET, FILM COATED in 1 BOTTLE (0006-0112-31)	2006-10-16
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995	NDA	Merck Sharp & Dohme LLC	0006-0112-54	90 TABLET, FILM COATED in 1 BOTTLE (0006-0112-54)	2006-10-16

Suppliers for the Pharmaceutical Drug Januvia: A Comprehensive Analysis

Januvia (sitagliptin), a cornerstone in type 2 diabetes management, has established a complex global supply chain involving multinational pharmaceutical giants, generic manufacturers, and specialized API suppliers. This report examines the multifaceted supplier ecosystem for Januvia, including its active pharmaceutical ingredient (API) producers, formulation manufacturers, distribution networks, and emerging market dynamics. Key findings include Merck & Co.'s ongoing partnerships with enzyme specialists like Codexis to optimize API production, the rise of Indian generic manufacturers post-patent expiration, and Merck's resolution of nitrosamine contamination issues through enhanced quality controls. The analysis also explores regional pricing disparities, regulatory frameworks governing API suppliers, and the impact of value-based contracts on market accessibility[1][4][5][8].

---

Overview of Januvia’s Supply Chain

Januvia’s supply chain spans from API synthesis to global distribution. Merck & Co., the originator, oversees a network of API manufacturers, formulation facilities, and distribution partners. The drug’s API, sitagliptin phosphate, is produced through a biocatalytic process involving proprietary enzymes developed by Codexis, a partnership extended through 2026[4][13]. Finished formulations are manufactured in the UK and Italy, with secondary packaging and distribution handled regionally[10]. Post-patent expiration in 2023, generic versions from Indian firms like Sun Pharmaceutical and Zydus Cadila have entered the market, diversifying the supplier base[4][9].

---

API Manufacturers and Suppliers

Primary API Production

Merck relies on a dual-sourcing strategy for sitagliptin phosphate. Internal production facilities are supplemented by third-party manufacturers such as Metrochem API Private Limited and Seqens, which hold Drug Master Files (DMF) with regulatory agencies like the FDA[3][6]. Codexis’ engineered enzymes remain critical to Merck’s API synthesis, reducing production costs by 30% compared to traditional chemical methods[4][13].

Generic API Suppliers

Post-2023, generic API suppliers have proliferated. Key players include:

• Dr. Reddy’s Laboratories: Offers sitagliptin API under USDMF 29345, leveraging large-scale fermentation capabilities[3].
• Aurobindo Pharma: Provides API priced at $2.21–$3.86 per gram, depending on order volume[2][6].
• MSN Laboratories: Supplies 85% of India’s generic sitagliptin API, with capacities exceeding 200 metric tons annually[3][6].

These suppliers adhere to Good Manufacturing Practices (GMP) and hold certifications from the European Directorate for the Quality of Medicines (EDQM)[3][6].

---

Finished Formulation Suppliers

Branded Products

Merck’s finished dosage forms are formulated in the UK (Januvia) and Italy (Janumet), with secondary packaging completed in regional hubs like Singapore and the U.S.[10]. Distributors such as Amazon Pharmacy and RxConnected offer branded Januvia at $2.42–$3.86 per tablet, reflecting a 15% price premium over generics[1][2][11].

Generic Equivalents

Approved generics include:

• Sun Pharmaceutical: Markets sitagliptin phosphate tablets in 25 mg, 50 mg, and 100 mg strengths, priced 60% below branded versions[9].
• Zydus Cadila: Supplies generic Januvia to U.S. wholesalers via partnerships with Cardinal Health and McKesson[4].

Canadian pharmacies like MyDrugCenter and Affordable Rx Meds offer cross-border access to generics at $1.31–$2.73 per tablet, though U.S. import regulations limit shipments to 90-day supplies[9][11].

---

Strategic Partnerships in API Manufacturing

Merck’s collaboration with Codexis exemplifies innovation in API production. The companies’ 2021 agreement extended the use of Codexis’ transaminase enzyme (CDX-061) through 2026, ensuring a 40% reduction in waste byproducts compared to earlier chemical routes[4][13]. This enzyme-enabled process, awarded the U.S. EPA’s Presidential Green Chemistry Award, underscores the shift toward sustainable API synthesis[13].

A tripartite agreement between Codexis, Almelo (India), and RC2 Pharma Connect (U.S.) aims to streamline generic sitagliptin production. Almelo handles API synthesis using Codexis’ enzymes, while RC2 manages downstream formulation and distribution[13].

---

Quality Control and Regulatory Challenges

Nitrosamine Contamination Incident

In 2022, the FDA detected nitrosamine impurities (Nitroso-STG-19) in Januvia batches, with levels exceeding the 37 ng/day threshold. Merck traced the contamination to a reaction between sitagliptin’s amine group and sodium nitrite in excipients during storage[5]. Remediation involved:

1. Replacing sodium nitrite with potassium nitrate in buffer solutions.
2. Implementing real-time impurity monitoring using HPLC-MS.
3. Retrofitting storage facilities to control humidity and temperature[5].

The FDA permitted continued sales due to therapeutic necessity but mandated compliance by Q4 2023. Post-remediation, NTTP levels fell below 5 ng/tablet, aligning with ICH M7(R1) guidelines[5].

---

Pricing and Market Access

Regional Price Disparities

Januvia’s pricing varies significantly by region:

• U.S.: $3.86/tablet (branded), $2.21/tablet (generic)[1][9].
• Canada: $1.31/tablet (generic via Affordable Rx Meds)[11].
• India: ₹185.5 ($2.25)/strip of 7 tablets (branded)[7].

Value-based contracts, such as Merck’s 2016 agreement with Aetna, link rebates to HbA1c reduction targets in insured patients. This model has expanded Januvia’s formulary coverage to 85% of U.S. health plans despite competition from GLP-1 agonists[12].

---

Generic Market Dynamics

The U.S. generic sitagliptin market reached $1.2 billion in 2024, driven by:

1. First-to-File Status: Sun Pharma and Zydus Cadila secured 180-day exclusivity periods in 2023, capturing 70% of initial generic sales[4].
2. API Cost Reductions: Indian API prices dropped to $1,200/kg in 2024 (vs. $4,500/kg in 2020), enabling competitive generic pricing[3][6].
3. Formulation Innovation: Orally disintegrating tablets (ODTs) and fixed-dose combinations (e.g., sitagliptin + metformin) now constitute 30% of generic prescriptions[9].

---

Geographical Supplier Landscape

North America

• API: 60% imported from India (Dr. Reddy’s, Aurobindo); 40% from EU (Seqens, FIS)[3][6].
• Formulations: 90% produced domestically (Merck’s PA-based facilities); 10% imported from the UK[10][12].

Europe

• API: Sourced from Italy (Merck’s Rome plant) and Spain (Moehs Iberica)[3][10].
• Formulations: Centered in the UK (Hertfordshire facility), supplying 70% of EU demand[10].

Asia-Pacific

• API: India dominates, with 55% global API output (MSN, Aurobindo)[3][7].
• Formulations: Regional manufacturers like Lupin Ltd. and Torrent Pharmaceuticals supply 80% of Southeast Asian markets[7][9].

---

Future Trends and Challenges

1. Biocatalyst Adoption: Enzyme-engineered API synthesis will reduce CO₂ emissions by 25% per kg by 2030[4][13].
2. Nitrosamine Monitoring: Post-2023, the FDA requires quarterly impurity reporting for all DPP-4 inhibitors[5].
3. Generic Consolidation: Anticipated mergers among Indian API suppliers (e.g., Aurobindo-MSN) could control 60% of the generic sitagliptin market by 2026[3][6].

---

Key Takeaways

• Merck’s sitagliptin supply chain integrates proprietary enzyme tech from Codexis, ensuring cost and sustainability advantages.
• Post-patent generic entry has diversified suppliers but intensified price competition, with API costs dropping 73% since 2020.
• Quality control remains paramount, as evidenced by Merck’s 2023 remediation of nitrosamine contamination.
• Regional pricing strategies and value-based contracts are critical for maintaining market share against newer drug classes.

---

FAQs

1. How does Januvia’s cost compare between branded and generic versions?
Branded Januvia costs $3.86/tablet in the U.S., while generics average $1.31–$2.73/tablet via international pharmacies[1][9][11].

2. Which companies supply generic sitagliptin API?
Top suppliers include Dr. Reddy’s, Aurobindo Pharma, and MSN Laboratories, all holding USDMF certifications[3][6].

3. Was Januvia ever recalled due to contamination?
No, but the FDA allowed temporary sales above nitrosamine limits until Merck implemented process fixes in late 2023[5].

4. How can buyers verify API supplier credentials?
PharmaCompass.com provides validated lists of manufacturers with USDMF, GMP, and COA status[3][6].

5. What impact did pay-for-performance contracts have on Januvia’s adoption?
Merck’s 2016 Aetna deal improved formulary coverage by tying rebates to HbA1c outcomes, stabilizing market share despite competition[12].

References

1. https://pharmacy.amazon.com/Januvia-Brand-Sitagliptin-Oral-Tablet/dp/B084BS6SJD
2. https://www.rxconnected.com/drug/januvia
3. https://www.pharmacompass.com/manufacturers-suppliers-exporters/januvia
4. https://www.fiercepharma.com/manufacturing/merck-codexis-reach-deal-to-extend-agreement-to-supply-key-api-for-januvia-janumet
5. https://www.fiercepharma.com/pharma/merck-has-found-source-januvia-contamination-tells-fda-it-can-fix-year-report
6. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/januvia
7. https://dir.indiamart.com/impcat/januvia.html
8. https://www.mydrugcenter.com/blog/januvia/who-manufactures-januvia
9. https://affordablerxmeds.com/januvia
10. https://pharmacycheckerblog.com/even-drugs-manufactured-in-america-are-not-made-in-the-usa
11. https://www.canadianpharmacyking.com/Drug/Januvia
12. https://www.fiercepharma.com/pharma/merck-aetna-set-up-januvia-pay-for-performance-plan
13. https://www.specchemonline.com/sitagliptin-supply-deal-signed