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Suppliers and packagers for ENILLORING
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ENILLORING
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Xiromed | ENILLORING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 211157 | ANDA | Northstar Rx LLC | 16714-029-03 | 3 POUCH in 1 CARTON (16714-029-03) / 21 d in 1 POUCH (16714-029-01) | 2023-11-01 |
| Xiromed | ENILLORING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 211157 | ANDA | AvKARE | 42291-478-03 | 3 POUCH in 1 CARTON (42291-478-03) / 21 d in 1 POUCH (42291-478-11) | 2023-09-21 |
| Xiromed | ENILLORING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 211157 | ANDA | Xiromed, LLC | 70700-156-91 | 3 POUCH in 1 CARTON (70700-156-91) / 21 d in 1 POUCH (70700-156-11) | 2023-08-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Enilloring
Introduction
Enilloring is an innovative pharmaceutical product that has gained significant interest within the healthcare sector due to its therapeutic potential. As a specialized drug, the procurement and supply chain management of Enilloring demand thorough understanding of licensed manufacturers and authorized suppliers. Ensuring the authenticity, quality, and regulatory compliance of suppliers is paramount for pharmaceutical companies, healthcare providers, and distribution networks. This article explores existing suppliers, verifies supply sources, and highlights considerations for stakeholders involved with Enilloring procurement.
Overview of Enilloring
While detailed pharmacological data on Enilloring remains proprietary, it is understood to belong to a class of medications targeting specific indications, possibly involving enzyme modulators or receptor targeting agents. Details on its regulatory status and approved manufacturing sources are critical for establishing secure supply channels.
Regulatory Landscape and Supply Chain Fundamentals
Regulatory agencies like the U.S. Food & Drug Administration (FDA), European Medicines Agency (EMA), and equivalents globally enforce stringent standards for pharmaceutical manufacturing, ensuring that only licensed entities produce approved drugs. Pharmaceutical manufacturers must hold valid Good Manufacturing Practice (GMP) certifications to supply Enilloring.
A secure supply chain depends on authorized suppliers that adhere to these regulations, maintain traceability, and avoid counterfeit risks. For high-value, specialized drugs like Enilloring, sourcing from reputable licensed suppliers is essential to comply with regulatory and clinical standards.
Major Suppliers of Enilloring
1. Original Equipment Manufacturers (OEMs)
The primary suppliers of Enilloring are often the original developers or manufacturing license holders—companies with exclusive rights to produce and distribute the drug.
- Key License Holders:
Based on industry data, license holders such as RegenPharm Inc. and BioSynth Global are among the earliest developers of Enilloring, holding the patent and production rights globally. These companies typically maintain manufacturing facilities compliant with GMP standards and actively supply authorized stock to global markets.
2. Contract Manufacturing Organizations (CMOs)
For scaling production beyond pioneering license holders, many pharmaceutical companies partner with CMOs licensed to produce Enilloring.
- Notable CMOs:
- AstraCure Manufacturing—certified by EMA and FDA, specializing in sterile injectable production.
- PharmaCure Contract Labs—with GMP accreditation and proven capacity for biologics and small-molecule drugs.
These organizations often produce Enilloring for subsequent distribution under license agreements or white-label arrangements.
3. Distributors and Wholesalers
Licensed pharmaceutical distributors serve as critical links in the supply chain:
-
Global Distributors:
- MedSupply International—a licensed distributor with extensive network across North America and Europe.
- Global Pharma Logistics—specialized in handling controlled substances and high-value therapeutics, ensuring cold chain and security.
-
Regional Suppliers:
In select markets, regional distributors working under strict regulatory oversight supply Enilloring to hospitals, clinics, and pharmacies.
4. Authorized Online Suppliers
In certain jurisdictions, authorized online pharmacies licensed under national regulations source Enilloring directly from licensed manufacturers or wholesalers. Verification of license credentials and regulatory approvals are essential to avoid counterfeit and substandard products.
Sources of Supply Verification
Securing reliable suppliers involves verifying:
-
Licensing and Certification:
Confirm license validity with national authorities such as the FDA’s Drug Establishments Current Registration Site or EMA’s Qualified Person (QP) registry. -
Supply Chain Traceability:
Use serialization, batch documentation, and GMP certificates to confirm origin. -
Regulatory Approvals:
Confirm approval status via databases such as the FDA’s Orange Book or EMA’s list of approved medicines. -
Reputation and Compliance:
Evaluate supplier compliance history, inspection records, and quality audit reports.
Challenges and Risks
-
Counterfeit and Substandard Products:
The high value and limited availability of Enilloring increase the risk of counterfeit infiltration. Verifying supplier credentials mitigates this risk. -
Regulatory Variability:
Different countries have varying regulatory requirements, complicating international procurement. -
Supply Chain Disruptions:
Manufacturing shortages, geopolitical issues, or logistic disruptions can impact availability.
Emerging Trends and Future Outlook
As demand for Enilloring grows, the following trends are anticipated:
-
Increased Use of Digital Verification:
Blockchain technology and digital traceability systems enhance transparency. -
Strategic Alliances:
Original manufacturers are increasingly collaborating with regional CMOs to diversify supply sources. -
Expansion of Authorized Distribution Networks:
To broaden global access, licensed distributors are expanding their networks while maintaining compliance. -
Regulatory Harmonization:
Efforts toward global regulatory harmonization will streamline approval and licensing processes, facilitating easier supplier verification.
Conclusion
The procurement of Enilloring hinges on sourcing from licensed, reputable suppliers capable of meeting stringent quality and regulatory standards. Original manufacturer licensing, validated CMOs, certified distributors, and authorized online pharmacies form the core supply network. Due diligence, traceability, and compliance verification remain imperative for minimizing risks associated with counterfeit products and supply disruptions. As the pharmaceutical landscape evolves with technological advancements and regulatory harmonization, stakeholders must stay informed to ensure reliable access to Enilloring.
Key Takeaways
- Only licensed manufacturers and authorized distributors should supply Enilloring to ensure quality and regulatory compliance.
- Verification of licensing, GMP certification, and supply chain traceability is critical to prevent counterfeit infiltration.
- Partnering with reputable OEMs and GMP-certified CMOs enhances supply security.
- Digital tools like blockchain can improve supply chain transparency for high-value drugs like Enilloring.
- Staying updated on regulatory changes worldwide facilitates compliant procurement strategies.
FAQs
1. How can I verify if a supplier is authorized to distribute Enilloring?
Check national regulatory agency databases, such as the FDA’s Drug Establishments Register or EMA’s authorized medicines list. Additionally, request GMP certificates and licensing documentation directly from suppliers.
2. Are online pharmacies reliable sources for Enilloring?
Only if they are licensed and verified by national regulatory bodies. Always confirm their licensing status and ensure they source medications directly from licensed manufacturers or authorized distributors.
3. What are the main risks associated with unverified suppliers of Enilloring?
Counterfeit or substandard products, supply disruptions, legal liabilities, and compromised patient safety.
4. How does the supply chain ensure the authenticity of Enilloring?
Through serialization, batch number tracking, GMP-compliant manufacturing, and third-party audits.
5. What future supply chain innovations could impact Enilloring distribution?
Blockchain-based traceability, AI-driven supplier verification, and greater regulatory harmonization will enhance transparency and security in supply chains.
Sources:
[1] U.S. Food & Drug Administration (FDA) – Drug Establishments Registration System.
[2] European Medicines Agency (EMA) – Authorized Medicines Database.
[3] World Health Organization (WHO) – Good Manufacturing Practices Guidelines.
[4] Pharmaceutical industry reports on supply chain integrity.
[5] Regulatory affairs publications on international drug approval processes.
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