Suppliers and packagers for generic pharmaceutical drug: FOSAMPRENAVIR CALCIUM

FOSAMPRENAVIR CALCIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	FOSAMPRENAVIR CALCIUM	fosamprenavir calcium	TABLET;ORAL	204060	ANDA	Mylan Pharmaceuticals Inc.	0378-3520-91	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91)	2017-09-18
Sun Pharm	FOSAMPRENAVIR CALCIUM	fosamprenavir calcium	TABLET;ORAL	204024	ANDA	Sun Pharmaceutical Industries, Inc.	63304-583-01	100 TABLET, COATED in 1 BOTTLE (63304-583-01)	2019-11-28
Sun Pharm	FOSAMPRENAVIR CALCIUM	fosamprenavir calcium	TABLET;ORAL	204024	ANDA	Sun Pharmaceutical Industries, Inc.	63304-583-30	30 TABLET, COATED in 1 BOTTLE (63304-583-30)	2019-11-28
Sun Pharm	FOSAMPRENAVIR CALCIUM	fosamprenavir calcium	TABLET;ORAL	204024	ANDA	Sun Pharmaceutical Industries, Inc.	63304-583-60	60 TABLET, COATED in 1 BOTTLE (63304-583-60)	2019-11-28

FOSAMPRENAVIR CALCIUM SUPPLY CHAIN ANALYSIS

Last updated: February 19, 2026

This report details key suppliers, manufacturing considerations, and intellectual property relevant to the pharmaceutical drug FOSAMPRENAVIR CALCIUM. The analysis focuses on the chemical synthesis and production of the active pharmaceutical ingredient (API).

API MANUFACTURING CAPABILITIES

Companies specializing in complex organic synthesis and cGMP (current Good Manufacturing Practice) compliant production are critical for FOSAMPRENAVIR CALCIUM API manufacturing. The synthesis involves multiple steps, often requiring chiral resolution and specialized reagents.

Primary Chemical Synthesis Routes

Several synthetic pathways exist for FOSAMPRENAVIR CALCIUM. Key intermediates and their suppliers are identified where publicly available or inferable from patent literature.

• Route 1 (Example Pathway): Involves coupling a protected amino alcohol with a substituted phenylacetic acid derivative. This route requires specific coupling reagents and controlled reaction conditions.
• Route 2 (Alternative Pathway): May utilize a different order of functional group introduction and protection strategies. This could impact intermediate sourcing and overall yield.

Key Intermediate Suppliers

Identification of specific suppliers for intermediates is often proprietary. However, based on chemical structures and common outsourcing practices in the pharmaceutical industry, the following types of companies are likely involved:

• Specialty Chemical Manufacturers: Companies with expertise in producing advanced intermediates, often on a custom synthesis basis. These firms typically operate under strict quality control protocols.
• API Manufacturers with Backward Integration: Larger API manufacturers may produce key intermediates in-house to ensure supply chain security and cost control.

PATENT LANDSCAPE AND INTELLECTUAL PROPERTY

The patent landscape for FOSAMPRENAVIR CALCIUM, particularly concerning its synthesis and polymorphic forms, is a significant factor for market entry and competitive strategy.

Core Compound Patents

• Original composition of matter patents have expired or are nearing expiration, opening avenues for generic development.
• Patents related to specific salt forms, such as FOSAMPRENAVIR CALCIUM, may still be in force, requiring careful examination.
• Formulation patents, covering specific dosage forms and delivery methods, also exist.

Process Patents

• Patents covering novel or improved synthetic routes are crucial. These can provide a competitive advantage by offering higher yields, lower impurity profiles, or more cost-effective production methods.
• Patents on specific purification techniques or crystallization processes can impact API quality and cost.

Polymorphism and Patent Protection

• Different crystalline forms (polymorphs) of FOSAMPRENAVIR CALCIUM can exhibit varying solubility, stability, and bioavailability.
• Patents protecting specific polymorphic forms are common and can extend market exclusivity for branded products. Generic manufacturers must ensure their API does not infringe on these patents.
• Studies of solid-state properties are essential for identifying and characterizing polymorphic forms.

FOSAMPRENAVIR CALCIUM API SUPPLIERS

Direct identification of FOSAMPRENAVIR CALCIUM API suppliers requires access to confidential market intelligence. However, companies with demonstrated capabilities in antiviral API manufacturing, particularly protease inhibitors, are the most probable sources.

Potential API Manufacturing Organizations (CMOs/CDMOs)

Based on their historical involvement in similar complex APIs and their regulatory compliance, the following types of companies are likely candidates:

• API Manufacturers specializing in HIV Antivirals: Companies that have produced other protease inhibitors or nucleoside reverse transcriptase inhibitors.
• Global API Producers with cGMP Capabilities: Large-scale manufacturers with a broad portfolio and established quality systems.
• Specialty Chemical Companies with API Development Services: Firms that offer integrated services from process development to commercial API manufacturing.

Table 1: Indicative Supplier Categories for FOSAMPRENAVIR CALCIUM API

Category	Rationale
Specialty Organic Synthesis	Expertise in multi-step synthesis of complex chiral molecules.
cGMP Compliant Pharmaceutical Manufacturers	Demonstrated adherence to regulatory standards for API production and quality assurance.
HIV/Antiviral Drug Manufacturers	Proven track record in producing APIs for this therapeutic class, including related structural motifs.
Contract Development and Manufacturing Organizations (CDMOs)	Offer custom synthesis and manufacturing services, often with intellectual property protection.

Supply Chain Considerations for Generic Entry

For generic manufacturers, securing a reliable and cost-effective API supplier is paramount. This involves:

• Supplier Auditing: Rigorous evaluation of manufacturing sites for quality, capacity, and regulatory compliance (FDA, EMA, etc.).
• Cost Analysis: Negotiating API pricing based on volume, synthesis efficiency, and competitive landscape.
• Intellectual Property Clearance: Ensuring the chosen API manufacturing process does not infringe on existing patents. This includes reviewing process patents and polymorphic patents.
• Regulatory Filings: Working with suppliers to gather necessary documentation for Drug Master Files (DMFs) or Active Substance Master Files (ASMFs).

REGULATORY AND QUALITY STANDARDS

Production of FOSAMPRENAVIR CALCIUM API must adhere to stringent global regulatory requirements.

Current Good Manufacturing Practices (cGMP)

• FDA and EMA Guidelines: Manufacturers must comply with the latest cGMP regulations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
• ICH Q7: This guideline outlines the specific cGMP requirements for the manufacturing of Active Pharmaceutical Ingredients.
• Quality Management Systems: Robust QMS, including change control, deviation management, CAPA (Corrective and Preventive Actions), and OOS (Out-of-Specification) investigations.

Impurity Profiling and Control

• ICH Q3A and Q3B: Guidelines for impurities in new drug substances and drug products, respectively.
• Process-Related Impurities: Identification and control of impurities arising from raw materials, reagents, and by-products of the synthesis.
• Degradation Products: Understanding potential degradation pathways and controlling impurities formed during storage.
• Genotoxic Impurities: Special attention must be paid to the identification and control of potentially genotoxic impurities, as per ICH M7.

KEY TAKEAWAYS

• The FOSAMPRENAVIR CALCIUM supply chain relies on specialty chemical manufacturers and experienced API producers with cGMP compliance.
• Patent expiration of the core compound opens opportunities, but process and polymorphic patents require careful navigation by generic entrants.
• Key considerations for API sourcing include quality, cost, regulatory compliance, and intellectual property clearance.
• Manufacturers must adhere to strict global cGMP standards and rigorously control impurity profiles.

FREQUENTLY ASKED QUESTIONS

1. What are the primary chemical building blocks for FOSAMPRENAVIR CALCIUM synthesis? The synthesis typically involves coupling a protected amino alcohol derivative with a substituted phenylacetic acid fragment, requiring various specialized reagents and catalysts.
2. Which regulatory bodies' guidelines are most critical for FOSAMPRENAVIR CALCIUM API manufacturers? Manufacturers must adhere to guidelines from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), including ICH Q7 for API cGMP.
3. How does polymorphism impact FOSAMPRENAVIR CALCIUM API sourcing for generic companies? Patents on specific polymorphic forms can extend market exclusivity. Generic companies must ensure their API production does not infringe on these patents and that the chosen polymorph meets bioequivalence requirements.
4. What is the typical lead time for securing a supply agreement for a complex API like FOSAMPRENAVIR CALCIUM? Lead times can vary significantly but often range from 6 to 18 months, encompassing supplier qualification, process validation, and initial production batches.
5. Beyond the API, what other components are critical in the FOSAMPRENAVIR CALCIUM finished drug product supply chain? Critical components include excipients (binders, fillers, disintegrants), packaging materials (bottles, blisters), and specialized manufacturing equipment for tablet or capsule production.

CITATIONS

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidance-industry [2] European Medicines Agency. (n.d.). Guidance Documents. Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-ich-harmonisation-harmonisation-ich-region_en.html [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2000). ICH Harmonised Tripartite Guideline Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2021). ICH Harmonised Guideline M7(R2): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. [5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2006). ICH Harmonised Tripartite Guideline Q3A(R2): Impurities in New Drug Substances.