Suppliers and packagers for generic pharmaceutical drug: SITAGLIPTIN HYDROCHLORIDE

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

Sitagliptin Hydrochloride Suppliers (API and Finished Dosage): Who Supplies It, Where Sourcing Risks Sit, and How to Shortlist Vendors

Last updated: June 1, 2026

Sitagliptin hydrochloride is supplied by a multi-tier network of API manufacturers (including chemical synthesis and key intermediate makers) and by contract manufacturing organizations (CMOs) that formulate and package finished-dose tablets for brand and generic markets. Supplier selection is typically constrained by (1) regulatory status for the specific site, (2) DMF/CEP readiness and compatibility with FDA ANDA filings, (3) impurity profiles and process validation history, (4) ability to supply commercial volumes and packaging configurations, and (5) quality-system track record.

Who supplies sitagliptin hydrochloride API for ANDA and commercial manufacture?

Finished-dose and API supply is typically split between:

• Sitagliptin API producers supplying to branded manufacturers, generic ANDA filers, and pharma distributors.
• Intermediate producers (for key steps) that feed qualified API sites.
• CMOs that purchase API and produce tablets and finished packaging.

API supplier patterns: what buyers actually look for

For sitagliptin hydrochloride, buyers screen vendors on:

• Regulatory dossiers: whether the vendor’s site is covered by an FDA DMF (or is supporting an ANDA) and whether the profile matches the target ANDA’s impurity limits.
• Parenteral-irrelevant: sitagliptin is oral solid, so supply focus is on solid-state quality, impurity control, and tablet performance.
• Stability and polymorph control: the API supplier’s ability to support consistent physical properties for downstream tableting.
• Audit history: inspection outcomes and remediation performance.

Common sourcing regions

Sitagliptin API supply is concentrated in established small-to-mid sized specialty chemical hubs and broader API ecosystems, typically in:

• China
• India
• Europe (select specialty capabilities)

(These locations dominate global API capacity for many DPP-4 inhibitors, and sitagliptin follows the same sourcing logic for ANDA and generic manufacturing.)

What finished-dose manufacturers supply sitagliptin tablets (Januvia and generics)?

Sitagliptin is marketed as tablets under brand and multiple generics. Finished-dose supply is typically handled by:

• Originator brand manufacturing networks
• Generic tablet manufacturers producing ANDA-labeled tablets using purchased sitagliptin hydrochloride API

How to map finished-dose suppliers to the market

A reliable mapping approach is via:

• FDA labeling and ANDA sponsor/manufacturer names
• Orange Book-linked product records (listed manufacturers per dosage form)
• DMF cross-links (when available through ANDA assignment patterns)

Because sitagliptin is widely generified, finished-dose manufacturing is split across multiple ANDA holders and contract plants.

Which companies have sitagliptin hydrochloride API and intermediate capability?

Sitagliptin hydrochloride API is produced through chemical synthesis routes that require proprietary control over intermediate purity and final impurity profile. In practice, API buyers often short-list vendors that also have:

• Established specialty synthesis capability
• Stable supply chain for key intermediates
• Track record supporting ANDA timelines

Short-list vendor selection rubric (sitagliptin-specific)

For sitagliptin hydrochloride, shortlist vendors that can provide:

• Batch CoA coverage for regulated impurities at the exact ranges used in current ANDA specifications
• Analytical method validation packages aligned to the buyer’s downstream specs
• Stability data for packaging and temperature profiles used by tablet manufacturers
• Demonstrated ability to support scale-ups without impurity drift

How do DMF and Orange Book entries affect which sitagliptin API suppliers qualify?

FDA DMF status and Orange Book product listings drive “qualified supplier” selection more than brand perception.

What DMF readiness means commercially

When a manufacturer files or supports an ANDA, they typically need:

• An API supply chain that can meet the AND A specification for sitagliptin hydrochloride, including impurity profile.
• A site that can be inspected and validated on a timeline compatible with filing and launch.

What Orange Book listings change

Orange Book entries show:

• The ANDA holder and branded counterpart relationship
• Listed dosage forms and sometimes the manufacturer identity on the record

These listings support procurement planning by narrowing the set of suppliers that feed specific ANDA launch platforms.

What patent or exclusivity constraints affect sitagliptin sourcing and generic entry?

Sitagliptin itself is widely available as generic. Patent-driven sourcing constraints usually impact:

• Formulation or method-of-use exclusivity (where applicable)
• Brand-specific process improvements (less common at this stage)
• Fixed-dose combination exclusivity (if relevant, e.g., sitagliptin plus metformin, though this is a different product category than pure sitagliptin hydrochloride)

In the current market, procurement is more constrained by quality/regulatory readiness than by active exclusivity on the base API.

What are the main supply risks for sitagliptin hydrochloride API?

Supplier selection for sitagliptin hydrochloride is primarily a risk management exercise.

Quality and regulatory risks

• Variability in impurity profile from process drift
• Insufficient controls around stability-relevant properties
• Facility inspection outcomes that cause delays in qualification

Operational risks

• Intermediate supply constraints leading to API shortages
• Batch-to-batch consistency problems that slow down tablet formulation validation
• Lead-time variability due to seasonal or energy-related manufacturing disruptions

How should procurement teams shortlist sitagliptin hydrochloride API vendors?

A defensible shortlist typically uses a two-stage filter.

Stage 1: regulatory and technical alignment

• Confirm the vendor’s regulatory dossier pathway for sitagliptin hydrochloride API
• Verify impurity controls match buyer ANDA or commercial tablet specs
• Require stability and analytical method documentation aligned to downstream processing

Stage 2: scale, reliability, and audit readiness

• Confirm production capacity to meet forecasted tablet demand
• Review change-control discipline and deviation history
• Conduct technical and quality audits focused on impurity management and process validation

What documentation do buyers request from sitagliptin hydrochloride suppliers?

Procurement files typically include:

• API CoA and impurity panel
• Specification sheet and analytical methods
• Stability data under intended storage conditions
• GMP certificates and audit reports
• Packaging and labeling controls relevant to oral solid manufacture

Key Takeaways

• Sitagliptin hydrochloride sourcing is driven by regulatory dossier readiness (DMF/ANDA compatibility) and impurity profile control, not just price.
• API supply is global, with concentration in major API hubs; qualification is site-specific.
• Finished-dose manufacturing is multi-sponsor and multi-plant; procurement should link API supplier capability to the intended tablet ANDA platform.
• Shortlist vendors using a two-stage screen: regulatory/technical alignment first, then capacity and audit readiness.

FAQs

1. What impurity profile requirements matter most for sitagliptin hydrochloride API qualification for ANDAs?
2. How do DMF site inspections influence sitagliptin hydrochloride API supplier acceptance?
3. Which documents are typically required to qualify a new sitagliptin hydrochloride supplier for tablet manufacturing?
4. What are common bottlenecks in sitagliptin hydrochloride intermediate supply that delay API production?
5. How does supplier change control affect tablet bioequivalence-relevant quality attributes for sitagliptin products?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. Drug Master Files (DMF). FDA.