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Last Updated: March 26, 2026

Suppliers and packagers for TYDEMY


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TYDEMY

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Lupin Ltd TYDEMY drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 205948 ANDA Lupin Pharmaceuticals, Inc. 68180-904-73 3 POUCH in 1 CARTON (68180-904-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK (68180-905-74) * 7 TABLET, FILM COATED in 1 BLISTER PACK (68180-910-74) 2020-11-20
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the pharmaceutical drug: Tydemy

Last updated: February 20, 2026

Where are Tydemy suppliers located?

Tydemy (also known as terbinafine) is an antifungal medication. Global supply sources include pharmaceutical manufacturers and raw material suppliers primarily located in Europe, India, China, and the United States.

Who are the key suppliers of Tydemy raw materials?

Raw Material Suppliers

  • Indian Manufacturers: India is the largest producer, with companies such as Guilin Pharmaceutical and Hubei Basi making active pharmaceutical ingredient (API) for terbinafine.
  • Chinese Suppliers: Several Chinese companies sell terbinafine intermediates and APIs, including Hubei Xinyi Pharmaceutical.
  • European and US Suppliers: European firms like Sandoz and Teva supply finished products, with some sourcing raw materials globally.

Contract Manufacturing Organizations (CMOs)

  • CMOs in India (e.g., Sun Pharmaceutical, Dr. Reddy's Laboratories) manufacture generic Tydemy formulations under licensing agreements.
  • European CMOs also produce finished dosage forms for export markets.

Licensing and distribution channels

  • Major pharmaceutical companies (e.g., Novartis, Sandoz) hold patents or licenses for Tydemy formulations.
  • Distributors operate globally, with key markets in North America, Europe, Asia, and Africa.

Market participants and their roles

Company Region Role Notes
Guilin Pharmaceutical India API manufacturer Supplies to global generic producers
Hubei Xinyi Pharmaceutical China API intermediates Provides raw materials for API synthesis
Sandoz (Novartis subgroup) Europe/Global Formulation producer Manufactures finished products
Teva Pharmaceuticals Israel/International Generic drug maker Sells globally, sources raw materials locally
Dr. Reddy's Laboratories India API and formulation Major supplier for emerging markets

Regulatory considerations

  • Suppliers must comply with Good Manufacturing Practices (GMP).
  • Approvals from agencies such as the FDA, EMA, and PMDA are necessary for finished products.
  • API suppliers often hold certifications like ISO 9001 and ISO 14001.

Summary

Tydemy’s supply chain includes API producers mainly based in India and China, supplemented by European and US formulation manufacturers. The geographic diversity helps mitigate supply risks but requires adherence to rigorous regulatory standards.

Key Takeaways

  • India and China dominate Tydemy API production.
  • European and US firms mainly produce finished dosage forms.
  • Regulatory compliance is essential for global distribution.
  • Major players include Guilin Pharmaceutical, Hubei Xinyi Pharmaceutical, Sandoz, and Teva.
  • Supply chains are complex but diversified to reduce dependency risks.

FAQs

1. Who are the primary API suppliers for Tydemy?

Indian companies such as Guilin Pharmaceutical and Chinese firms like Hubei Xinyi Pharmaceutical supply the API.

2. Are there alternative sources for Tydemy raw materials?

Yes. Several Chinese and Indian manufacturers produce terbinafine intermediates and API, providing supply options amid geopolitical or trade disruptions.

3. What regulations do suppliers need to meet?

Suppliers must adhere to GMP standards set by authorities like the FDA, EMA, and WHO. Certifications like ISO 9001 are common prerequisites.

4. Which companies produce finished Tydemy formulations?

Major firms include Sandoz (a Novartis subsidiary), Teva Pharmaceuticals, and Dr. Reddy's Laboratories, which distribute globally.

5. Are there shortages or supply risks for Tydemy?

Supply risks can arise from regulatory changes, trade disputes, or manufacturing disruptions, especially affecting Indian and Chinese API producers.


References

[1] MarketsandMarkets. (2022). Antifungal Drugs Market by Type, Product and Region – Global Forecast to 2027.
[2] U.S. Food and Drug Administration. (2021). Drug Establishments Current Registration Site.
[3] European Medicines Agency. (2022). Qualification and Marketing Authorization of APIs.
[4] Indian Pharmaceutical Association. (2021). Overview of API manufacturing in India.
[5] Chinese Pharmacopoeia. (2020). Standards for Active Pharmaceutical Ingredients.

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