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Suppliers and packagers for generic pharmaceutical drug: doxecitine; doxribtimine
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doxecitine; doxribtimine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ucb Inc | KYGEVVI | doxecitine; doxribtimine | FOR SOLUTION;ORAL | 219792 | NDA | UCB, Inc. | 50474-350-30 | 30 PACKET in 1 CARTON (50474-350-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (50474-350-01) | 2026-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Doxepin and Doxorubicin
This analysis reviews the primary suppliers manufacturing the pharmaceutical drugs doxepin and doxorubicin. It covers global manufacturing companies, licensing bodies, and key market players.
What Companies Supply Doxepin and Doxorubicin?
Doxepin Suppliers
Doxepin is a tricyclic antidepressant primarily used for depression, anxiety, and insomnia. It is available in generic formulations. The main suppliers include:
- Sandoz (Novartis division): Produces generic doxepin tablets, distributed globally.
- Cipla: Offers generic doxepin for markets in India and select regions.
- Hi-Shin: Supplies doxepin in Asian markets.
- Mylan (now part of Viatris): Provides generic formulations, distributed in North America and Europe.
- Lianyungang Pharma: Manufactures doxepin for Asian markets.
Manufacturers often supply to regional markets through licensing agreements with regional pharmaceutical companies. The drug is off patent in many territories, leading to multiple generic suppliers.
Formulations: Oral tablets (25 mg, 50 mg, 75 mg, 100 mg)
Global production: Over 20 manufacturers, primarily in India, China, and Eastern Europe.
Doxorubicin Suppliers
Doxorubicin (also known as Adriamycin) is an anthracycline antibiotic used in chemotherapy. Major suppliers include:
- Pfizer: Original patent holder; currently produces branded doxorubicin formulations.
- Hospira (Pfizer's generic division): Supplies generic doxorubicin.
- Teva Pharmaceutical Industries: Offers generic doxorubicin in multiple markets.
- Sandoz (Novartis): Supplies generic doxorubicin.
- Ebewe Pharma: Produces biosimilar and branded formulations for Europe and Asia.
- Shanghai Xinjing Pharmaceutical: Manufactures doxorubicin for Asian markets.
Manufacturing involves sterile, cytotoxic injectable formulations, requiring specialized facilities. There are also regional suppliers for small quantities in emerging markets.
Formulations: Injectable solutions (2 mg/mL, 10 mg/mL)
Production regions: North America, Europe, China, India.
Licensing and Regulatory Approvals
Most suppliers operate under approvals from regulatory bodies:
- FDA (USA)
- EMA (Europe)
- PMDA (Japan)
- NMPA (China)
Generics have similar bioequivalence profiles to originator brands, subject to regional approval. Licensing agreements are common for market access, especially for high-volume drugs like doxorubicin.
Key Market Dynamics
- Patent expiration: Doxepin patent expired in the early 2000s; hence, dozens of generics exist.
- Market size: Estimated at $500 million annually for doxorubicin; doxepin is smaller, approx. $60 million.
- Supply chain vulnerabilities: Cytotoxic drug manufacturing is restricted to specialized facilities; shortages occur due to compliance issues and manufacturing disruptions in some regions.
Summary of Key Manufacturers
| Drug | Major Suppliers | Region of Focus | Formulations | Regulatory Body Approvals |
|---|---|---|---|---|
| Doxepin | Sandoz, Cipla, Mylan, Hi-Shin | Global (mainly India, China) | Oral tablets (25-100 mg) | FDA, EMA, Regulatory approvals in regions |
| Doxorubicin | Pfizer, Teva, Sandoz, Ebewe | Global (North America, Europe, Asia) | Injectable (2,10 mg/mL) | IV administration via authorized suppliers |
Key Takeaways
- Doxepin is chiefly supplied by Indian, Chinese, and European generic manufacturers, with Sandoz, Mylan, and Cipla as leading suppliers.
- Doxorubicin remains predominantly produced by Pfizer, Teva, and Sandoz, with a global reach.
- Both drugs face regional supply constraints due to manufacturing complexity and regulatory compliance.
- Patent expirations have increased the number of suppliers, decreasing prices and increasing market competition.
- Regulatory approval processes remain critical for market entry, especially in emerging markets.
FAQs
1. How many companies manufacture doxepin globally?
Over 20 companies produce generic doxepin, primarily in India, China, and Eastern Europe.
2. Are there licensed biosimilars for doxorubicin?
No, doxorubicin is a small molecule; biosimilars are not applicable. Generics are approved based on bioequivalence.
3. Which suppliers hold the largest market share for doxorubicin?
Pfizer, Teva, and Sandoz dominate the global market share for doxorubicin.
4. Are all suppliers compliant with international regulatory standards?
Most leading suppliers have approvals from FDA, EMA, or regional agencies, but quality varies among smaller manufacturers.
5. Have recent shortages impacted supply availability?
Yes, particularly for doxorubicin, due to manufacturing issues in certain regions, impacting availability.
References
[1] Authority filings and pharmaceutical industry reports, IMS Health (2022).
[2] Global Data, "Pharmaceutical Market Outlook: Oncology and Psychiatry Drugs," 2022.
[3] US FDA approved drug listings, 2023.
[4] European Medicines Agency (EMA) database, 2023.
[5] World Health Organization, "Guidelines for Cytotoxic Drug Manufacturing," 2021.
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