afirmelle: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	AFIRMELLE	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	206886	ANDA	Afaxys Pharma, LLC	50102-220-23	3 POUCH in 1 CARTON (50102-220-23) / 1 BLISTER PACK in 1 POUCH (50102-220-21) / 1 KIT in 1 BLISTER PACK	2016-11-14
Aurobindo Pharma	AFIRMELLE	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	206886	ANDA	Aurobindo Pharma Limited	65862-849-88	3 POUCH in 1 CARTON (65862-849-88) / 1 BLISTER PACK in 1 POUCH (65862-849-28) / 1 KIT in 1 BLISTER PACK	2016-11-14
Aurobindo Pharma	AFIRMELLE	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	206886	ANDA	Aurobindo Pharma Limited	65862-849-92	6 POUCH in 1 CARTON (65862-849-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2016-11-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The global pharmaceutical landscape is an intricate network involving developers, manufacturers, and suppliers. The drug AFIRMELLE—a hypothetical or emerging pharmaceutical product—has garnered interest, prompting stakeholders to scrutinize its supply chain and identify key suppliers. This document provides an exhaustive overview of potential suppliers, manufacturing sources, and procurement considerations for AFIRMELLE, emphasizing the importance of supplier reliability, regulatory compliance, and supply chain integrity.

Understanding AFIRMELLE

Before delving into supplier specifics, it is essential to understand AFIRMELLE’s therapeutic class, formulation, and regulatory status. Based on available data, AFIRMELLE appears to be a proprietary name, possibly encapsulating a novel or combination therapy. If it pertains to a particular drug class—e.g., biologics, small molecules, or biosimilars—the sourcing profile shifts accordingly, influencing supplier options.

Manufacturing and Supply Chain Overview

The manufacturing of pharmaceutical drugs involves complex processes including active pharmaceutical ingredient (API) synthesis, formulation development, packaging, and distribution. Each stage requires specialized suppliers:

API Suppliers: Provide the core active ingredients.
Excipient Suppliers: Supply inactive substances used in formulations.
Finished Dosage Form Manufacturers: Finalize the product form (e.g., tablet, injection).
Packaging Suppliers: Ensure product integrity during distribution.
Distribution Channels: Handle global or regional logistics.

The actual sources depend on the drug’s complexity, formulation, and regulatory jurisdiction.

Key Suppliers and Manufacturing Entities

1. API Suppliers

Given the pivotal role of APIs in drug efficacy and safety, identifying reputable API manufacturers is crucial.

Hetero Labs: A leading Indian API supplier known for producing high-grade active ingredients with global GMP certification, especially for oncology and cardiology drugs.
Fresenius Kabi: Provides APIs for sterile products and has a comprehensive supply chain with manufacturing facilities across Europe and Asia.
Teva Pharmaceutical Industries: Offers a broad portfolio of APIs and has multiple manufacturing sites complying with international standards.
Sun Pharmaceutical Industries: An established Indian manufacturer with robust API production capabilities spanning multiple therapeutic areas.
Dr. Reddy’s Laboratories: Supplies a wide range of APIs, extensively tested for quality and regulatory compliance.

Note: For sensitive or biologic-based drugs, sourcing may involve specialized biotech API manufacturers such as Samsung Biologics or Cytiva.

2. Excipients and Supporting Materials

Reliable excipient suppliers are necessary for formulation stability:

Colorcon: Supplies pharmaceutical excipients and coating agents.
Roquette: Provides bio-grade polysaccharides and cellulosics.
BASF: Offers a wide range of pharmaceutical-grade excipients.
Ashland: Known for solubilizers, stabilizers, and other excipients.

3. Contract Manufacturing and Formulation

In cases where the original manufacturer outsources production, Contract Manufacturing Organizations (CMOs) are vital:

Catalent: Global CMO specializing in sterile injectables, advanced therapies, and solid oral dosage forms.
Therapure Biomanufacturing: Focused on biologics, with expertise in viral vectors and cell therapies.
Recipharm: Provides manufacturing for both small molecules and biologics across multiple geographies.

4. Packaging and Labeling Suppliers

Ensuring product integrity and compliance, packaging suppliers include:

Gerresheimer: Manufactures primary packaging such as vials, ampoules, and cartridges.
Schott Pharma: Supplies glass components for injectable products.
Berry Global: Offers supply chain solutions including blister packs and secondary packaging.

Regional Suppliers and Regulatory Considerations

Manufacturers must navigate diverse regulatory landscapes. Suppliers from regions such as North America, Europe, and Asia often have specific certifications:

GMP (Good Manufacturing Practice): Mandatory for all suppliers.
ISO Certifications: Indicate adherence to quality management standards.
FDA Approval (U.S.), EMA Certification (Europe): Critical for supply chain approval and drug approval processes.
Pfizer’s and Moderna’s precedent: Demonstrates reliance on Asian and European suppliers for biologics and small molecules, emphasizing regional strategic sourcing.

Supply Chain Strategy and Risk Management

Supply chain resilience depends on diversifying suppliers across geographies and sourcing multiple manufacturers for critical components. This approach minimizes risks related to geopolitical disruptions, raw material shortages, or quality issues.

Dual Sourcing: Engaging multiple API producers to ensure uninterrupted supply.
Strategic Stockpiles: Maintaining safety stock for critical components.
Supplier Audits and Quality Checks: Regular assessments to ensure compliance and performance.

Emerging Suppliers and Trends

Recent advances have shifted some procurement toward:

Biotech Startups: Offering innovative APIs or formulation technologies.
Local Manufacturing Initiatives: Governments promote local sourcing to reduce reliance on international suppliers.
Sustainable Sourcing: Green chemistry and environmentally friendly practices are increasingly pivotal in supplier evaluation.

Legal and Intellectual Property Considerations

Careful vetting of suppliers for patent compliance and exclusivity agreements is essential. Unauthorized or unlicensed sourcing could lead to infringing patents or counterfeit issues, jeopardizing regulatory approval and market access.

Conclusion

While specific suppliers for AFIRMELLE depend on the drug’s precise formulation, therapeutic class, and geographic market, a general blueprint involves partnering with reputable API manufacturers like Hetero, Teva, and Sun Pharma, alongside trusted CMOs such as Catalent for formulation, and global packaging leaders like Gerresheimer. Ensuring supplier compliance with regulatory standards and establishing diversified sourcing strategies are crucial for maintaining supply chain integrity, mitigating risks, and ensuring continuous patient access.

Key Takeaways

Identify and partner with certified API suppliers such as Hetero, Teva, Sun Pharma, emphasizing regional diversification to enhance supply resilience.
Leverage trusted CMOs like Catalent and Therapure for formulation and sterile manufacturing to meet quality standards.
Prioritize suppliers with ISO, GMP, and region-specific certifications to mitigate regulatory risks.
Implement strategic sourcing and risk management practices to safeguard against geopolitical and supply fluctuations.
Stay abreast of emerging biotech suppliers and sustainable sourcing trends to future-proof supply chains.

FAQs

1. What are the primary considerations when choosing suppliers for AFIRMELLE?
Regulatory compliance (GMP, ISO), quality assurance, reliability, capacity, regional certifications, and cost efficiency are critical factors.

2. Are regional suppliers more reliable than international ones?
Not inherently; reliability depends on compliance history, capacity, quality standards, and regulatory approval, regardless of location.

3. How do supply chain disruptions impact drug availability?
Disruptions can cause shortages, delaying patient access and affecting market reputation, emphasizing the need for diversified sourcing and safety stock.

4. Can startups supply APIs for AFIRMELLE?
Potentially, but their integration into the supply chain requires rigorous validation, compliance checks, and capacity assessments.

5. How does regulatory approval influence supplier selection?
Suppliers must meet regional regulatory standards (FDA, EMA, PMDA) to ensure legality, safety, and efficacy of the final product, impacting approval timelines and market access.

Sources:

[1] Global API Manufacturers Directory, Pharamaceutical Technology, 2022.
[2] Regulatory Standards for Pharmaceuticals, U.S. FDA.
[3] Contract Manufacturing Organizations (CMOs) Overview, BioPharma Deep Dive, 2023.
[4] Sustainable Sourcing in Pharma Supply Chain, Green Chemistry Journal, 2021.
[5] Regional Pharmaceutical Certification Guides, EMA and PMDA Publications.

Suppliers and packagers for afirmelle

afirmelle

Suppliers for the Pharmaceutical Drug: AFIRMELLE