Suppliers and packagers for generic pharmaceutical drug: nateglinide

nateglinide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cadila Pharms Ltd	NATEGLINIDE	nateglinide	TABLET;ORAL	206432	ANDA	Cadila Pharmaceuticals Limited	71209-030-04	90 TABLET, COATED in 1 BOTTLE (71209-030-04)	2014-02-10
Cadila Pharms Ltd	NATEGLINIDE	nateglinide	TABLET;ORAL	206432	ANDA	Cadila Pharmaceuticals Limited	71209-030-05	100 TABLET, COATED in 1 BOTTLE (71209-030-05)	2014-02-10
Cadila Pharms Ltd	NATEGLINIDE	nateglinide	TABLET;ORAL	206432	ANDA	Cadila Pharmaceuticals Limited	71209-031-04	90 TABLET, COATED in 1 BOTTLE (71209-031-04)	2014-02-10

Suppliers and packagers for generic pharmaceutical drug: nateglinide

Last updated: May 25, 2026

Nateglinide Suppliers: Who Manufactures, Supplies APIs, and Controls Commercial Supply

Nateglinide commercial supply is dominated by a mix of global generics manufacturers (finished-dose tablets) and specialized API producers (nateglinide bulk drug substance). The supplier landscape also includes contract manufacturers for tablets and secondary packaging, plus API/finished-dose licensors supporting product launches and line extensions.

Which companies supply nateglinide tablets (finished-dose products)?

Finished-dose nateglinide products are supplied through generic and branded channels. In most jurisdictions, tablets are manufactured by generic drug companies and supplied to local distributors, wholesalers, and tenders.

Typical supplier structure for nateglinide tablets

• API-to-finished-dose vertically integrated firms: companies that produce or qualify nateglinide API and then manufacture tablets.
• API purchasers using contract manufacturers: firms that buy nateglinide API and outsource tablet manufacturing, coating, and packaging.
• Local marketing authorization holders (MAHs): often separate from actual manufacturing sites.

Common tablet supply pattern

• Multiple strengths exist by market (notably 60 mg, 120 mg).
• Each market’s supply depends on which MAH holds the local marketing authorization and which manufacturing site is listed for GMP release.

Who supplies nateglinide API (bulk drug substance)?

Nateglinide API is supplied by bulk drug manufacturers that produce nateglinide and sell to formulation makers under supply agreements and DMFs/letters of authorization. The key procurement drivers for API buyers are DMF status, stability/impurity profile, polymorph control, and auditability of production sites.

API supplier selection criteria buyers use

• DMF or ASMF support and ability to support regulatory submissions
• Verified impurity and residual solvent profile consistent with approved specs
• Batch-to-batch consistency and validated analytical methods
• GMP inspection history and capacity availability
• Ability to support scale-up for commercial production

What API manufacturers are active suppliers for nateglinide (global)?

API suppliers for older small-molecule generics like nateglinide typically include:

• Tier-1 Indian generic API producers
• Chinese API manufacturers supplying global intermediates and APIs
• Specialty European/US API providers (less common for widely marketed older molecules, more common where there is stronger customer concentration or tighter impurity/spec requirements)

A complete, jurisdiction- and strength-specific supplier roster requires tying nateglinide API vendors to (1) labeled finished-dose MAHs and (2) the listed manufacturing sites for each product, because API sourcing is often shared across multiple tablet SKUs.

Which contract manufacturing organizations (CMOs) make nateglinide tablets?

CMOs supply tablet manufacturing services for generic MAHs:

• Blending and granulation (wet or dry, depending on formulation)
• Tablet compression and coating
• Quality control release testing (in-process and finished product)
• Secondary packaging and labeling under GMP

Caution points that impact CMO qualification

• Tableting excipient compatibility and bioavailability alignment
• Stability data adequacy for the proposed packaging configuration
• Analytical method transfer for dissolution and related assays
• Ability to produce in commercial volumes with validated cleaning and impurity controls

What are the main procurement channels for nateglinide supply?

Nateglinide supply is typically procured through:

• Direct contracts with API makers for bulk drug substance
• Supply agreements with finished-dose manufacturers for tender/market launches
• Distributor frameworks for short lead-time procurement
• Regulatory-linked sourcing where procurement is constrained by DMF/ASMF and validated manufacturing sites already accepted by regulators

Procurement driven by regulatory readiness

For regulated markets, buyers usually lock in supply only after:

• Approved manufacturing site listings
• Release testing comparability
• Regulatory filing alignment (DMF/CEP/ASMF references)

How do nateglinide tablet suppliers differ by strength (60 mg vs 120 mg)?

Strength can change supplier economics because:

• Some plants may be optimized for one tablet strength based on tooling and compression settings.
• Coating parameters and dissolution targets can vary by strength, even when the active ingredient is the same.
• Stability packaging and shelf-life commitments can create supplier switching friction.

Procurement typically favors suppliers that can produce both strengths on the same equipment train or with tightly managed change controls.

What patent or regulatory factors affect who can supply nateglinide?

Nateglinide is an older small molecule, so supplier entry is typically driven by:

• DMF ownership and right-to-reference
• ANDA/market authorization availability in each country
• cGMP inspection outcomes
• bioequivalence and formulation comparability

Once product-level authorizations exist, supply depends less on exclusivity and more on manufacturing approvals and dossier status.

What generic entry risks exist for nateglinide suppliers?

For tablet suppliers, the main risks are not clinical but operational:

• Failure to meet dissolution specifications in process transfers
• Impurity excursions (including byproducts from synthesis route variations)
• Inadequate stability under real-time conditions for the intended shelf-life
• Regulatory delays if the manufacturing site change triggers filing updates

Key Takeaways

• Nateglinide supply is handled by a combination of nateglinide API makers, tablet manufacturers, and CMOs supporting GMP production.
• Procurement is usually constrained by regulatory dossier linkage (DMF/ASMF) and listed manufacturing sites rather than by theoretical technical ability.
• Strength-specific manufacturing parameters (60 mg vs 120 mg) can influence which suppliers are operationally best positioned.
• Commercial supplier selection focuses on cGMP track record, impurity/spec compliance, and ability to support scale-up and regulatory maintenance.

FAQs

1) Who are the main nateglinide API suppliers used by generic tablet manufacturers?
API sourcing is generally concentrated in established small-molecule API producers that can support DMF/ASMF documentation and maintain tight impurity controls.

2) Can different suppliers provide nateglinide tablets with the same strength (60 mg/120 mg)?
Yes, but bioequivalence and dissolution specification adherence must be maintained under each product authorization, and manufacturing sites are typically tied to regulatory filings.

3) What determines whether a new supplier can enter the nateglinide market?
Ability to manufacture under GMP, dossier/DMF referencing rights, and regulatory clearance for the specific market and strength.

4) What are the most common reasons a nateglinide supplier change gets delayed?
Analytical method transfer issues, dissolution nonconformance, impurity profile drift, and packaging/stability gaps that require regulatory updates.

5) Are contract manufacturers a common source of nateglinide tablets?
Yes. Many MAHs rely on CMOs for tablet compression, coating, QC release testing, and packaging under GMP.

References

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA database).
2. FDA. Drug Master Files (DMF) and regulatory guidance on referencing. (FDA website).
3. EMA. European public assessment reports (EPAR) and related procedural guidance for generic medicinal products. (EMA website).