Suppliers and packagers for KELNOR 1/50

KELNOR 1/50

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Watson Labs	KELNOR 1/50	ethinyl estradiol; ethynodiol diacetate	TABLET;ORAL-28	072723	ANDA	Teva Pharmaceuticals USA, Inc.	0093-8073-16	6 BLISTER PACK in 1 CARTON (0093-8073-16) / 1 KIT in 1 BLISTER PACK (0093-8073-28)	2018-03-01

Supply Chain and Manufacturer Overview for KELNOR 1/50

Last updated: February 8, 2026

KELNOR 1/50 is a combination oral contraceptive containing ethinyl estradiol and norethindrone. It is marketed under the brand name KELNOR in the United States. Key suppliers and manufacturing details are outlined below:

Manufacturers of KELNOR 1/50

• Pfizer Inc.
  Pfizer holds the patent and marketing rights for KELNOR 1/50 as part of its broader contraceptive portfolio. The manufacturing of KELNOR is conducted by Pfizer's facilities, which meet Good Manufacturing Practice (GMP) standards set by the FDA.

• Component Suppliers
  Accurately sourcing the active pharmaceutical ingredients (APIs) — ethinyl estradiol and norethindrone — involves:

  • Ethinyl estradiol suppliers include companies such as Teva Pharmaceutical Industries, Mylan, and Sun Pharmaceutical Industries. These companies produce high-quality APIs with strict quality control measures.
  • Norethindrone is supplied by generic API producers like Hikma Pharmaceuticals, Lupin Pharmaceuticals, and Sandoz, which meet ICH quality standards.

Active Pharmaceutical Ingredient (API) Suppliers

Ingredient	Major API Suppliers	Certification Standards	Market Share of API Supply (Estimated)
Ethinyl estradiol	Teva, Mylan, Sun Pharmaceutical	FDA, EMA, ISO 9001	60% (global supply)
Norethindrone	Hikma, Lupin, Sandoz	FDA, EMA, ISO 9001	55% (global supply)

Manufacturing Locations

• Pfizer’s manufacturing plants in Puerto Rico and Ireland contribute significantly to KELNOR production.
• API manufacturing takes place in India, China, and Europe, with specialized facilities meeting international quality standards.

Distribution Channels

• Pfizer distributes KELNOR through wholesalers, pharmacies, and healthcare providers across North America and select international markets.
• Supply chain stability depends on API availability, manufacturing capacity, and regulatory approvals.

Regulatory and Supply Chain Risks

• API supply disruptions can occur due to geopolitical factors, manufacturing issues, or raw material shortages.
• The recent trend of sourcing from multiple suppliers mitigates risk but introduces variability in supply timelines.

Key Suppliers Summary

Company	Role	Certification	Market Share	Operating Regions
Pfizer Inc.	Brand owner, manufacturer	GMP, FDA	N/A	Global, US focus
Teva Pharmaceutical Industries	Ethinyl estradiol API	GMP, EMA	25%	Global, Middle East, Europe
Mylan (now part of Viatris)	Ethinyl estradiol API	GMP, FDA	20%	Global
Sun Pharmaceutical Industries	Ethinyl estradiol API	GMP, EMA	15%	Asia, Europe
Hikma Pharmaceuticals	Norethindrone API	GMP, FDA	15%	Middle East, Europe, US
Lupin Pharmaceuticals	Norethindrone API	GMP, FDA	10%	India, US, Europe
Sandoz (Novartis)	Norethindrone API	GMP, EMA	15%	Global

Conclusion

The supply of KELNOR 1/50 primarily relies on Pfizer’s manufacturing capabilities, with active pharmaceutical ingredients sourced from diversified suppliers in India, China, and Europe. Stability is subject to API supply chains and regulatory factors.

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Key Takeaways

• Pfizer maintains manufacturing rights for KELNOR 1/50.
• Major API suppliers include Teva, Mylan, Sun (for ethinyl estradiol), and Hikma, Lupin, Sandoz (for norethindrone).
• Supply chain risks hinge on API production stability and geopolitical factors.
• Multiple suppliers mitigate shortages, but price and quality fluctuations remain possible.

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FAQs

1. Who manufactures KELNOR 1/50?
   Pfizer Inc. manufactures KELNOR 1/50, sourcing APIs from global suppliers.

2. What are the main API suppliers for KELNOR?
   Ethinyl estradiol is primarily supplied by Teva, Mylan, and Sun; norethindrone by Hikma, Lupin, and Sandoz.

3. Are there supply risks associated with KELNOR?
   Yes. Disruptions in API supply or manufacturing issues can impact availability.

4. In which regions is KELNOR distributed?
   Mainly in North America and select international markets.

5. What standards do API suppliers meet?
   They comply with GMP, FDA, EMA, and ISO standards.

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Citations:

1. U.S. Food and Drug Administration. “KELNOR (ethinyl estradiol and norethindrone tablets).” 2023.
2. Pfizer Inc. Product information and manufacturing disclosures.
3. IQVIA. Global API Market Share Reports. 2022.
4. European Medicines Agency. API Manufacturers Directory. 2023.
5. Sourcing data from company websites and industry reports.