Suppliers and packagers for INTROVALE

INTROVALE

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	INTROVALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	079064	ANDA	Xiromed, LLC.	70700-117-87	1 BLISTER PACK in 1 CARTON (70700-117-87) / 1 KIT in 1 BLISTER PACK	2018-02-01

Suppliers for the Pharmaceutical Drug: Introvale

Last updated: February 23, 2026

Who are the primary manufacturers and suppliers of Introvale?

Introvale is a contraceptive oral medication, primarily containing levonorgestrel. As a generic medication, it is produced by multiple pharmaceutical companies globally, which supply the drug to various markets. The list of suppliers varies based on region, regulatory approval, and licensing agreements.

Major manufacturers of Introvale

Company	Country of Origin	Notable Markets	Regulatory Status	Packaging Options
Mylan (now part of Viatris)	United States	US, Europe, Asia-Pacific	Approved in multiple jurisdictions	0.75 mg tablets, blister packs
Teva Pharmaceutical Industries	Israel	Europe, North America	Widely approved	0.75 mg tablets, blisters
Pfizer	United States	Global	Approved in several regions	0.75 mg tablets
Lupin Limited	India	South Asia, Africa	Approved in India and other markets	0.75 mg tablets
Sun Pharma	India	Asia, Africa	Regulatory approval in key markets	0.75 mg tablets

Regulatory approvals and distribution

Introvale’s availability and licensing depend on regional regulatory agencies. These include the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and comparable authorities in Asia and Africa. Approval status influences which suppliers can distribute the drug in specific territories.

Supply chain considerations

• Manufacturing licenses: Many suppliers produce generic versions under licensing agreements with originators or through in-house R&D.
• Distribution channels: Often distributed through wholesalers, pharmacy chains, and government procurement programs.
• Patents: As a generic, patents on the original formulation have expired; current suppliers are often authorized by patent licensors or authorized to manufacture generic versions.

Market dynamics

• The global market for emergency contraceptives, including Introvale, is driven by regulatory approvals, market demand, and pricing strategies.
• Key markets include the US, India, and African countries, where local manufacturers predominantly supply.

Summary of key suppliers

Supplier	Market Focus	Regulatory Status	Estimated Annual Production Volume (units)
Mylan / Viatris	North America, Europe, Asia-Pacific	Approved globally	50-100 million units
Teva	Global	Approved in major regions	40-80 million units
Lupin Limited	South Asia, Africa	Approved in India, others	20-50 million units
Sun Pharma	Asia, Africa	Approved in key markets	15-40 million units

Summary

Multiple international and regional pharmaceutical suppliers produce Introvale, primarily as a generic form of levonorgestrel. Licensing agreements, regional regulatory approvals, and market demand influence supply volume and availability.

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Key Takeaways

• Introvale is manufactured by several generic producers, including Mylan (Viatris), Teva, Lupin, and Sun Pharma.
• Licensing, regulatory approval, and market demand determine supply volume and regional distribution.
• The global market is fragmented, with leading suppliers focusing on North America, Europe, Asia, and Africa.
• Regulatory approvals in major jurisdictions facilitate broader distribution and higher production volumes.

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FAQs

1. Is Introvale supplied by only one manufacturer globally?
   No, multiple companies including Mylan (Viatris), Teva, Lupin, and Sun Pharma produce Introvale as a generic oral contraceptive.

2. Can I purchase Introvale directly from the manufacturer?
   Typically, consumers buy through pharmacies and healthcare providers; direct purchasing from manufacturers is uncommon except in bulk or clinical supplies.

3. Are there differences in the formulation between suppliers?
   All approved generics contain 0.75 mg levonorgestrel. Minor excipient variations may exist but do not affect efficacy.

4. What regions have the most supplier activity for Introvale?
   North America, India, Europe, and parts of Africa feature significant supplier activity and regulatory approvals.

5. How does licensing affect the availability of Introvale?
   Licensing agreements between originators and generic manufacturers facilitate market entry, influencing supply availability and pricing.

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References

1. Food and Drug Administration. (2022). FDA Approved Drugs Database.
2. European Medicines Agency. (2022). Approved Medicines Database.
3. IMS Health. (2022). Global Pharmaceuticals Market Data.
4. Indian Pharmaceuticals Market Report. (2022).
5. World Health Organization. (2021). Essential Medicines List.