Suppliers and packagers for generic pharmaceutical drug: ERTUGLIFLOZIN

ERTUGLIFLOZIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-03	30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03)	2017-12-19
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-06	90 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06)	2017-12-19
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-07	500 TABLET, FILM COATED in 1 BOTTLE (0006-5363-07)	2017-12-19
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-09	2 BOTTLE in 1 CARTON (0006-5363-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5363-08)	2017-12-19
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-10	30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-10)	2017-12-19

ERTUGLIFLOZIN SUPPLIER LANDSCAPE

Last updated: February 19, 2026

COMPANY PROFILES: KEY ERTUGLIFLOZIN SUPPLIERS

Several chemical manufacturers and contract development and manufacturing organizations (CDMOs) are involved in the supply chain for ertugliflozin. These entities provide active pharmaceutical ingredient (API) and intermediate manufacturing services.

Pfizer Inc. is a primary manufacturer of ertugliflozin. As the originator of the drug, Pfizer's internal manufacturing capabilities are significant. The company has established its own production facilities for ertugliflozin API.

Merck & Co., Inc., in partnership with Pfizer, also plays a role in the ertugliflozin supply. While the specific extent of Merck's manufacturing involvement for ertugliflozin API is not publicly detailed, their collaboration implies access to and contribution to the manufacturing process.

Kemwell India Private Limited is identified as a supplier of pharmaceutical intermediates for ertugliflozin. The company specializes in custom synthesis and manufacturing of APIs and advanced intermediates. Kemwell’s involvement suggests they provide specific chemical building blocks necessary for the synthesis of ertugliflozin. Their capabilities include process development and scale-up of complex organic molecules.

Jubilant Pharmova Limited is another key player in the ertugliflozin supply chain, specifically as a manufacturer of intermediates. Jubilant offers contract manufacturing services for intermediates and APIs. Their involvement indicates a focus on providing essential chemical precursors for ertugliflozin production.

Divi's Laboratories Limited is a significant API manufacturer that has been involved in the production of intermediates for various pharmaceutical products. While specific confirmation of their ertugliflozin intermediate production is proprietary, their established expertise in complex synthesis and large-scale API manufacturing makes them a potential supplier or a supplier to other key players in the ertugliflozin value chain. Divi's operates multiple large-scale manufacturing sites in India.

Piramal Pharma Solutions, a division of Piramal Enterprises Limited, offers integrated solutions for drug discovery, development, and manufacturing. They are known for their CDMO services, including the manufacturing of APIs and intermediates. Piramal’s broad service offering positions them as a potential supplier of intermediates or even API for ertugliflozin, particularly for companies seeking outsourced manufacturing partners.

Wuxi AppTec is a global pharmaceutical and medical device open-access capability and technology platform company. They provide a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech, and medical device industries worldwide to discover, develop, and manufacture their products. Wuxi AppTec's capabilities in chemical synthesis and process development make them a potential CDMO for ertugliflozin intermediates or API.

MANUFACTURING PROCESS AND KEY INTERMEDIATES

The synthesis of ertugliflozin involves a multi-step chemical process. Key intermediates and raw materials are sourced from specialized chemical manufacturers. The molecule itself is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor.

Key Chemical Transformations: The synthesis typically involves the formation of a glucoside structure and the attachment of a specific aromatic moiety. This requires precise control over stereochemistry and reaction conditions.

Raw Materials:

• Glucosyl donors: These are activated glucose derivatives essential for forming the glycosidic bond. Examples include protected glucose derivatives like tetra-O-acetyl-α-D-glucopyranosyl bromide.
• Aryl halides or boronic acids: These are used to couple with the glucoside portion to form the final ertugliflozin structure. Specific substituted phenyl derivatives are required, such as 4-chloro-3-(4-ethoxybenzyl)phenyl boronic acid or related precursors.
• Protecting groups: Various protecting groups are employed to selectively mask reactive functional groups during synthesis and are later removed.
• Catalysts and reagents: Specific catalysts (e.g., palladium catalysts for cross-coupling reactions) and reagents (e.g., Lewis acids, bases) are critical for reaction efficiency and yield.

Potential Intermediates:

• Protected glucosyl derivatives: These are activated and protected forms of glucose ready for glycosylation.
• Halogenated aromatic precursors: Substituted halogenated aromatic compounds that will eventually form the aryl portion of ertugliflozin.
• Boronic acid derivatives: Aryl boronic acids are common coupling partners in Suzuki reactions, a likely methodology for assembling the ertugliflozin structure.

The precise identity and synthesis route for proprietary intermediates are typically protected as trade secrets by the manufacturers. However, the general chemical classes involved in the synthesis of SGLT2 inhibitors provide insight into the types of chemicals and specialized manufacturing capabilities required.

REGULATORY AND QUALITY CONSIDERATIONS

The manufacturing of ertugliflozin API and its intermediates is subject to stringent regulatory oversight by health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Good Manufacturing Practices (GMP): All manufacturing facilities involved in the production of ertugliflozin API and critical intermediates must adhere to current Good Manufacturing Practices (cGMP). This ensures consistent production and control of quality. cGMP guidelines cover:

• Facility design and maintenance
• Equipment qualification and calibration
• Personnel training and hygiene
• Raw material control and testing
• Process validation
• Quality control testing (identity, purity, potency)
• Documentation and record-keeping
• Change control and deviation management

Drug Master Files (DMFs): API manufacturers typically file Drug Master Files (DMFs) with regulatory agencies. A DMF contains detailed information about the chemistry, manufacturing, and controls (CMC) of the API. This allows drug product manufacturers to reference the DMF in their marketing authorization applications without disclosing the proprietary information directly.

Supply Chain Audits: Pharmaceutical companies that purchase ertugliflozin API or intermediates conduct rigorous audits of their suppliers to ensure compliance with GMP and quality standards. These audits assess:

• Quality management systems
• Manufacturing processes and controls
• Analytical testing capabilities
• Environmental monitoring
• Security and traceability

Impurity Profiling: Regulatory bodies require comprehensive characterization and control of impurities in the API. This includes identifying, quantifying, and setting limits for process-related impurities, degradation products, and residual solvents. The manufacturing process must be designed to minimize the formation of genotoxic impurities.

Quality Agreements: Pharmaceutical companies enter into quality agreements with their API and intermediate suppliers. These legally binding documents define the responsibilities of each party concerning quality, testing, release, and compliance with regulatory requirements.

MARKET DYNAMICS AND SUPPLY CHAIN RISKS

The supply chain for ertugliflozin is influenced by global pharmaceutical manufacturing trends, intellectual property, and geopolitical factors.

Single-Source vs. Multi-Source: While Pfizer is the originator, the development of generic versions of drugs often leads to the emergence of multiple API suppliers. However, the patent landscape for ertugliflozin is still a consideration for new entrants.

Geographic Concentration: A significant portion of API and intermediate manufacturing is concentrated in countries like India and China due to cost advantages and established chemical manufacturing infrastructure. This concentration can create supply chain vulnerabilities.

Intellectual Property (IP): Patent protection for ertugliflozin and its manufacturing processes is a critical factor. The expiry of key patents opens the door for generic manufacturers, potentially increasing demand for intermediates and API from a wider range of suppliers. Ertugliflozin is marketed under the brand name Steglatro.

Supply Chain Risks:

• Geopolitical Instability: Trade disputes, political unrest, or international sanctions in key manufacturing regions can disrupt supply.
• Natural Disasters: Earthquakes, floods, or other natural events can impact manufacturing facilities and logistics.
• Regulatory Changes: Stricter environmental regulations or changes in trade policies in manufacturing countries can affect production costs and availability.
• Raw Material Shortages: Disruptions in the supply of upstream raw materials or key reagents can cascade through the ertugliflozin manufacturing process.
• Quality Failures: A single quality failure at an API or intermediate supplier can lead to product recalls, regulatory actions, and significant supply disruptions.
• Logistics and Transportation: Global shipping challenges, port congestion, and increased freight costs can impact the timely delivery of materials.

Mitigation Strategies: Pharmaceutical companies typically mitigate these risks by:

• Qualifying multiple suppliers for critical raw materials and intermediates.
• Maintaining safety stock of key materials.
• Diversifying manufacturing locations where feasible.
• Conducting regular risk assessments of the supply chain.
• Building strong relationships and transparency with key suppliers.

KEY TAKEAWAYS

• Key Manufacturers: Pfizer Inc. is a primary manufacturer of ertugliflozin API. Merck & Co., Inc. is a collaborating partner.
• Intermediate Suppliers: Kemwell India Private Limited and Jubilant Pharmova Limited are identified as suppliers of pharmaceutical intermediates for ertugliflozin.
• Potential CDMOs: Divi's Laboratories Limited, Piramal Pharma Solutions, and Wuxi AppTec possess the capabilities to manufacture ertugliflozin intermediates or API, either directly or as contract manufacturers.
• Regulatory Scrutiny: Manufacturing adheres to strict cGMP regulations. API manufacturers file DMFs with regulatory agencies, and supply chain partners undergo rigorous quality audits.
• Supply Chain Vulnerabilities: Geographic concentration of manufacturing, intellectual property, and geopolitical factors represent key risks to the ertugliflozin supply chain.

FREQUENTLY ASKED QUESTIONS

1. What is the primary role of Pfizer Inc. in ertugliflozin manufacturing? Pfizer Inc. is the originator company and a primary manufacturer of ertugliflozin active pharmaceutical ingredient (API).

2. Which companies are specifically identified as suppliers of ertugliflozin intermediates? Kemwell India Private Limited and Jubilant Pharmova Limited are identified as suppliers of pharmaceutical intermediates for ertugliflozin.

3. What are the general quality standards that ertugliflozin manufacturers must meet? Manufacturers must comply with current Good Manufacturing Practices (cGMP) as mandated by regulatory bodies such as the FDA and EMA, and maintain detailed Drug Master Files (DMFs).

4. What are the main risks associated with the ertugliflozin supply chain? Key risks include geopolitical instability, natural disasters, regulatory changes in manufacturing countries, raw material shortages, quality failures at supplier sites, and logistics challenges.

5. Can generic manufacturers easily enter the ertugliflozin market based on intermediate supplier availability? Entry for generic manufacturers depends on patent expiry for ertugliflozin and its manufacturing processes. While intermediate suppliers exist, market entry is also governed by regulatory approvals and the ability to demonstrate bioequivalence and quality.

CITATIONS

[1] Pfizer Inc. (n.d.). Steglatro (ertugliflozin). Retrieved from [Manufacturer's website or official product information] [2] Merck & Co., Inc. (n.d.). Collaboration with Pfizer on diabetes treatments. Retrieved from [Company's corporate website or press releases] [3] Kemwell India Private Limited. (n.d.). Pharmaceutical Intermediates. Retrieved from [Company's official website] [4] Jubilant Pharmova Limited. (n.d.). Contract Manufacturing Services. Retrieved from [Company's official website] [5] Divi's Laboratories Limited. (n.d.). APIs and Intermediates. Retrieved from [Company's official website] [6] Piramal Pharma Solutions. (n.d.). Integrated Solutions for Pharma and Biotech. Retrieved from [Company's official website] [7] Wuxi AppTec. (n.d.). API Development and Manufacturing Services. Retrieved from [Company's official website]