Suppliers and packagers for generic pharmaceutical drug: LOXAPINE SUCCINATE

LOXAPINE SUCCINATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Elite Labs Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076868	ANDA	Elite Laboratories, Inc.	64850-890-01	100 CAPSULE in 1 BOTTLE (64850-890-01)	2020-01-27
Elite Labs Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076868	ANDA	Elite Laboratories, Inc.	64850-891-01	100 CAPSULE in 1 BOTTLE (64850-891-01)	2020-01-27
Elite Labs Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076868	ANDA	Elite Laboratories, Inc.	64850-892-01	100 CAPSULE in 1 BOTTLE (64850-892-01)	2020-01-27
Elite Labs Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076868	ANDA	Elite Laboratories, Inc.	64850-893-01	100 CAPSULE in 1 BOTTLE (64850-893-01)	2020-01-27

Loxapine Succinate Suppliers: Market Landscape and Manufacturing Capabilities

Last updated: February 19, 2026

This analysis identifies key suppliers of Loxapine Succinate API and its intermediates, detailing manufacturing capacities, regulatory compliance, and supply chain considerations for pharmaceutical companies. The market is characterized by a mix of established and emerging manufacturers, with a focus on quality control and Good Manufacturing Practices (GMP).

Who are the Primary Manufacturers of Loxapine Succinate API?

The production of Loxapine Succinate Active Pharmaceutical Ingredient (API) is concentrated among a limited number of specialized chemical manufacturers. These entities possess the requisite synthesis capabilities and adhere to stringent pharmaceutical quality standards.

• Key Manufacturers:
  • Actavis Pharma AS: A significant player with established API manufacturing facilities.
  • Sun Pharmaceutical Industries Limited: A global pharmaceutical company with a broad API portfolio, including antipsychotic agents.
  • Teva Pharmaceutical Industries Ltd.: A major generic drug manufacturer with extensive API production capabilities.
  • Mylan N.V. (now Viatris): Another large generic and specialty pharmaceutical company involved in API supply.
  • Aurobindo Pharma Limited: An Indian multinational pharmaceutical company with a strong API division.

These manufacturers typically operate multi-purpose plants capable of handling complex organic synthesis required for Loxapine Succinate. Their production sites are often subject to inspections by major regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What are the Critical Intermediates in Loxapine Succinate Synthesis?

The synthesis of Loxapine Succinate involves several key chemical intermediates. The reliable and consistent supply of these intermediates is crucial for API manufacturers.

• Primary Intermediates:
  • 2-chloro-11-(4-methyl-1-piperazinyl)dibenzo[b,f][1,4]oxazepine: This is a direct precursor to Loxapine. Its synthesis involves multiple steps, starting from simpler aromatic compounds.
  • Succinic Acid: A dicarboxylic acid that forms the succinate salt of Loxapine. It is a common commodity chemical, but pharmaceutical-grade succinic acid with controlled impurity profiles is required.
  • Dibenz[b,f][1,4]oxazepine derivatives: Various substituted dibenz[b,f][1,4]oxazepine structures are often synthesized as early-stage intermediates.
  • 4-methylpiperazine: A key building block for introducing the piperazine moiety.

Suppliers of these intermediates range from large-scale chemical producers to specialized fine chemical companies. The quality and purity of these intermediates directly impact the final API's specifications and regulatory compliance. Companies sourcing Loxapine Succinate API often conduct due diligence on their API manufacturers' sourcing of these critical raw materials.

What is the Regulatory Landscape for Loxapine Succinate API Manufacturers?

Manufacturers of Loxapine Succinate API must comply with rigorous regulatory standards to ensure product quality, safety, and efficacy.

• Key Regulatory Requirements:
  • Good Manufacturing Practices (GMP): Compliance with ICH Q7 guidelines for API GMP is mandatory. This includes robust quality management systems, documented procedures, validated processes, and rigorous analytical testing.
  • Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies (e.g., FDA, EMA). These confidential documents provide detailed information about the API's manufacturing process, facilities, quality control, and stability data. Pharmaceutical companies reference these DMFs in their drug product applications.
  • Inspections and Audits: API manufacturing sites are subject to routine inspections by regulatory authorities (FDA, EMA, PMDA, etc.). Pharmaceutical companies also conduct supplier audits to verify compliance and assess manufacturing capabilities.
  • Impurity Profiling: Comprehensive identification, qualification, and control of impurities are essential. This includes process-related impurities, degradation products, and residual solvents, as per ICH Q3A and Q3C guidelines.
  • Stability Studies: Manufacturers must conduct stability studies according to ICH Q1 guidelines to establish the retest period or shelf life of the API under defined storage conditions.

The presence of a US-DMF or CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia) is often a prerequisite for sourcing API for regulated markets.

Which Companies Offer Loxapine Succinate API for Commercial Supply?

Several companies are known to offer Loxapine Succinate API for commercial pharmaceutical product manufacturing. The availability and scale of supply can vary.

• Commercial Suppliers:
  • Sun Pharmaceutical Industries Limited: Offers Loxapine Succinate API, often referenced in generic drug filings.
  • Teva Pharmaceutical Industries Ltd.: A consistent supplier of API for its own generic products and potentially for external sale.
  • Aurobindo Pharma Limited: Has demonstrated capacity for producing a range of antipsychotic APIs, including Loxapine Succinate.
  • Actavis Pharma AS (part of Teva): May supply Loxapine Succinate API through its established API division.

These suppliers are often found through regulatory filings (e.g., FDA's Orange Book for approved generics which list API sources) and direct engagement with their business development teams. Contract Manufacturing Organizations (CMOs) can also play a role in producing Loxapine Succinate API under contract for pharmaceutical companies.

What are the Considerations for Sourcing Loxapine Succinate API?

Pharmaceutical companies evaluating Loxapine Succinate API suppliers must consider several critical factors to ensure a secure and compliant supply chain.

• Key Sourcing Factors:
  • Quality and Purity: Verification of API specifications, impurity profiles, and adherence to pharmacopoeial standards (e.g., USP, EP).
  • Regulatory Compliance: Confirmation of GMP certification, DMF filing status, and successful inspection history with relevant health authorities.
  • Manufacturing Capacity and Reliability: Assessment of the supplier's production volume capabilities, lead times, and historical reliability in meeting supply commitments.
  • Supply Chain Security: Evaluation of the supplier's raw material sourcing, risk mitigation strategies for supply disruptions, and geographical diversification of manufacturing if applicable.
  • Cost: Competitive pricing while ensuring quality and compliance are maintained.
  • Intellectual Property: Understanding patent landscapes for manufacturing processes, especially for newer or improved synthesis routes.
  • Technical Support: Availability of technical expertise from the supplier for formulation development and troubleshooting.

A robust supplier qualification program, including site audits and comprehensive quality agreements, is essential.

Are There any Specific Patent Considerations for Loxapine Succinate Manufacturing?

While Loxapine Succinate itself is a well-established drug with expired primary patents on the molecule, process patents and patents on specific crystalline forms or improved synthesis routes can still be relevant.

• Patent Landscape:
  • Composition of Matter Patents: The original patents covering Loxapine and its salts have long expired, allowing for generic competition.
  • Process Patents: Companies may develop and patent novel or improved synthetic routes that offer advantages in terms of yield, purity, cost, or environmental impact. These patents can influence which manufacturing processes are permissible for generic producers.
  • Polymorph Patents: Different crystalline forms (polymorphs) of Loxapine Succinate can have distinct physical properties (e.g., solubility, stability). Patents may exist for specific, advantageous polymorphs.
  • Formulation Patents: Patents may also cover specific pharmaceutical compositions or delivery systems utilizing Loxapine Succinate.

Manufacturers must conduct thorough freedom-to-operate (FTO) analyses to ensure their chosen manufacturing process and commercialization strategy do not infringe on existing patents. This is particularly important for API manufacturers developing proprietary synthesis methods or for generic companies selecting their API source.

Key Takeaways

• The Loxapine Succinate API market is served by established pharmaceutical manufacturers, with Sun Pharma, Teva, and Aurobindo Pharma identified as key players.
• Critical intermediates, notably 2-chloro-11-(4-methyl-1-piperazinyl)dibenzo[b,f][1,4]oxazepine and succinic acid, are essential for API production.
• Manufacturers must adhere to strict GMP regulations and maintain comprehensive DMFs for supply to regulated markets.
• Sourcing decisions require careful consideration of quality, regulatory compliance, manufacturing capacity, supply chain security, and cost.
• While the molecule is off-patent, process and polymorph patents can still impact manufacturing routes and commercialization strategies.

Frequently Asked Questions

What is the typical impurity profile of Loxapine Succinate API?

The typical impurity profile is detailed in pharmacopoeial monographs (e.g., USP, EP) and the DMFs submitted by manufacturers. Common impurities may include related substances from the synthesis, residual solvents, and degradation products. Manufacturers must control these to levels specified by regulatory guidelines (ICH Q3A/B/C).

How does the succinate salt form impact Loxapine's properties?

The succinate salt is chosen to improve Loxapine's physicochemical properties, such as solubility, stability, and bioavailability, compared to the free base. This is a standard practice for improving the performance of basic drug molecules.

What is the difference between Loxapine and Loxapine Succinate from a chemical perspective?

Loxapine is the free base form of the antipsychotic drug. Loxapine Succinate is the salt formed by reacting Loxapine with succinic acid. Salt formation is a common pharmaceutical technique to modify a drug's properties.

Can Loxapine Succinate API be sourced from China or India?

Yes, manufacturers in China and India are significant producers of APIs, including Loxapine Succinate. However, rigorous due diligence regarding GMP compliance, regulatory filings (DMFs), and quality control is essential when sourcing from any region.

What are the primary therapeutic uses of Loxapine Succinate?

Loxapine Succinate is an antipsychotic medication used primarily in the treatment of schizophrenia and other psychotic disorders. It is available in various dosage forms, including oral capsules and an inhaled formulation.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-file-system/drug-master-files-dmfs [2] European Medicines Agency. (n.d.). Active substances (APIs). Retrieved from https://www.ema.europa.eu/en/human-regulatory/production-quality-control/active-substances-apis [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Quality Guidelines. Retrieved from https://www.ich.org/page/quality-guidelines [4] United States Pharmacopeia. (n.d.). Monographs. Retrieved from https://www.uspnf.com/ [5] European Pharmacopoeia. (n.d.). Home. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia