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Suppliers and packagers for generic pharmaceutical drug: SITAGLIPTIN HYDROCHLORIDE
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SITAGLIPTIN 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 |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | BRYNOVIN | sitagliptin hydrochloride | SOLUTION;ORAL | 219122 | NDA | Azurity Pharmaceuticals, Inc. | 24338-017-01 | 1 BOTTLE in 1 CARTON (24338-017-01) / 120 mL in 1 BOTTLE | 2025-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Sitagliptin Hydrochloride
Introduction
Sitagliptin hydrochloride is an oral antihyperglycemic agent primarily used in the management of type 2 diabetes mellitus. It functions as a dipeptidyl peptidase-4 (DPP-4) inhibitor, facilitating increased incretin levels, which enhance insulin secretion and suppress glucagon production. Given its widespread adoption, the supply chain for sitagliptin HCl is complex, involving multiple suppliers across the pharmaceutical manufacturing landscape. Ensuring a reliable supply of high-quality sitagliptin hydrochloride is crucial for pharmaceutical companies, healthcare providers, and patients.
This report examines the key suppliers manufacturing sitagliptin hydrochloride, their sources of raw materials, manufacturing capacities, quality certifications, and implications for the supply chain.
Manufacturers of Sitagliptin Hydrochloride
1. Merck & Co., Inc. (MSD)
Overview:
Merck, the original developer of sitagliptin (marketed as Januvia), maintains an extensive internal supply chain for the active pharmaceutical ingredient (API). The company’s manufacturing plants for sitagliptin HCl are located in the United States and Europe, emphasizing high-quality standards aligned with cGMP compliance.
Supply capacity and control:
Merck supplies sitagliptin API predominantly for its proprietary formulations. Its integrated manufacturing process ensures supply stability, but direct procurement by external companies is limited and typically restricted to licensing or partnership agreements.
Certifications:
Merck's manufacturing facilities adhere to international standards such as GMP, ISO 9001, and regulatory approvals from agencies like the FDA, EMA, and WHO.
2. Hetero Labs Ltd. (India)
Overview:
Hetero is a leading Indian pharmaceutical company recognized for its extensive portfolio of APIs, including sitagliptin hydrochloride. It has invested significantly in manufacturing infrastructure to meet global standards.
Raw Material Sourcing:
Hetero sources precursor chemicals and intermediates from certified suppliers globally, ensuring high purity levels for API synthesis.
Production capacity:
Hetero’s facilities are equipped to produce thousands of kilograms monthly, serving both domestic and export markets.
Certifications:
GMP certification from the State Drug Standard Control, and export licensing to regulated markets such as the US, Europe, and Latin America, validate quality standards.
3. Natco Pharma Ltd. (India)
Overview:
Natco is another prominent Indian API manufacturer with capabilities in sitagliptin HCl production, leveraging advanced synthesis techniques and large-scale manufacturing.
Supply chain:
Natco operates under strict adherence to cGMP guidelines, sourcing high-grade intermediates, and maintaining quality assurance processes that meet international standards.
Global reach:
The company exports sitagliptin API to pharmaceutical manufacturers worldwide, including the US, Europe, and Asia.
Certifications:
GMP, ISO 9001, and certifications from regulatory authorities bolster its credibility.
4. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
Overview:
Zhejiang Huahai is one of the largest Chinese API manufacturers, with a significant portfolio including sitagliptin hydrochloride.
Manufacturing capability:
The company's facilities are equipped with advanced synthesis technology, capable of producing large quantities of sitagliptin API to meet global demand.
Market positioning:
Although the company faced some quality control issues in the past, recent compliance improvements have enhanced its reputation.
Certifications:
GMP compliance, with approvals from China’s NMPA (formerly CFDA), and some certifications for exports to regulated markets.
5. Other Notable Suppliers
-
Zhejiang Hisun Pharmaceutical Co., Ltd.
An established Chinese manufacturer providing sitagliptin API with global distribution. -
Alkem Laboratories Ltd. (India)
Known for producing campaign-specific batches, mainly for Indian markets but expanding globally. -
Sandoz (Novartis)
As a generic arm of Novartis, Sandoz supplies sitagliptin HCl formulations but not necessarily the API; however, their contracted manufacturers may supply sitagliptin raw materials.
Raw Material and Intermediates Sourcing
The synthesis of sitagliptin hydrochloride involves complex chemical intermediates, including amino acids, heterocyclic compounds, and chiral catalysts.
Key raw materials include:
- Amino acids (e.g., D-Ala or D-Phenylalanine derivatives): Sourced globally from reputed chemical suppliers such as Evonik, Ajinomoto, and Merck KGaA.
- Heterocyclic intermediates: Manufactured by specialized chemical companies capable of producing high-purity compounds.
- Chiral catalysts and reagents: Critical for stereoselective synthesis, often procured from established chiral chemical suppliers with stringent quality standards.
Global supply disruptions of critical raw materials can impact API production. Therefore, manufacturers maintain multiple sourcing partnerships and inventory buffers.
Supply Chain Considerations
Regulatory and Quality Certifications
Manufacturers of sitagliptin hydrochloride must comply with cGMP standards and obtain certifications such as ISO 9001, ISO 13485 (for related medical devices), and rigorous audits from regulatory authorities like the FDA and EMA.
Manufacturing Capacity and Scalability
High demand for sitagliptin, driven by the increasing prevalence of type 2 diabetes, necessitates scalable manufacturing processes. Leading suppliers have invested in expanding capacity and adopting continuous manufacturing techniques to meet global needs.
Geopolitical and Trade Factors
The global supply chain faces risks from geopolitical tensions, trade restrictions, and pandemic-related disruptions. Diversification of suppliers across regions—India, China, and Western countries—is essential for supply resilience.
Implications for Stakeholders
-
Pharmaceutical Companies:
Need to establish relationships with multiple API suppliers to mitigate risks associated with supply shortages and quality issues. -
Regulatory Authorities:
Require robust oversight to ensure API quality, especially from multinational suppliers operating in regions with evolving regulatory landscapes. -
Patients:
Rely on a consistent supply of high-quality drugs; supply chain disruptions could affect affordability and access. -
Investors and Market Analysts:
Should monitor production capacities, raw material sourcing stability, and geopolitical risks to gauge market stability for sitagliptin hydrochloride.
Key Takeaways
- Major suppliers of sitagliptin hydrochloride include Merck (internal), Indian companies such as Hetero and Natco, and Chinese manufacturers like Zhejiang Huahai.
- Raw material sourcing involves complex intermediates from global chemical suppliers, emphasizing the importance of diversified supply chains.
- Quality certification and adherence to GMP standards remain critical to ensuring safety and efficacy.
- Supply chain resilience depends on capacity expansion, geopolitical stability, and operational agility.
- Pharmaceutical companies should maintain multiple supplier relationships, monitor raw material markets, and ensure compliance to mitigate risks.
FAQs
1. Are there regional differences in sitagliptin hydrochloride suppliers?
Yes. Indian and Chinese manufacturers dominate the global supply due to cost advantages, while Western companies like Merck primarily supply their own formulations or licensed partners. Regional supply chains are influenced by regulatory standards and manufacturing capacity.
2. How does raw material sourcing impact the quality of sitagliptin API?
High-quality raw materials are essential for producing pure and effective sitagliptin hydrochloride. Suppliers adhering to international quality standards help ensure product consistency and regulatory compliance.
3. What are the risks associated with sourcing sitagliptin API from emerging markets?
Risks include varying quality standards, potential regulatory lapses, geopolitical instability, and supply disruptions. Diversification and rigorous quality audits mitigate these risks.
4. Can new suppliers enter the sitagliptin API market easily?
Entry requires substantial investment in R&D, GMP-compliant manufacturing facilities, and regulatory approvals. The high complexity of synthesis and strict quality standards serve as barriers to new entrants.
5. How do regulatory factors influence the global supply of sitagliptin hydrochloride?
Regulatory approvals from agencies like the FDA and EMA are critical. Non-compliance can result in supply restrictions, recalls, or bans, significantly impacting availability.
Sources
[1] Merck & Co. Official Website, 2022.
[2] Hetero Labs Ltd. Annual Report 2022.
[3] Natco Pharma Ltd. Product Portfolio, 2022.
[4] Zhejiang Huahai Pharmaceutical Official Reports, 2022.
[5] Regulatory standards: WHO, FDA, EMA guidelines on API manufacturing.
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