ORIAHNN (COPACKAGED): Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388	NDA	AbbVie Inc.	0074-1017-14	1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK	2020-05-29
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388	NDA	AbbVie Inc.	0074-1017-56	4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK	2020-05-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Oriahnn is a prescription combination drug used primarily for the treatment of heavy menstrual bleeding associated with uterine fibroids in women who desire to preserve fertility. The drug’s formulation includes relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, combined with estradiol and norethindrone acetate, packaged as a copackaged therapy. As a relatively new entrant in the pharmaceutical landscape, understanding the supply chain, key suppliers, and manufacturing partnerships for Oriahnn is essential for industry stakeholders, healthcare providers, and investors.

This report details the current landscape of suppliers contributing to Oriahnn’s manufacturing, including those involved in active pharmaceutical ingredient (API) sourcing, formulation, packaging, and distribution.

Manufacturers and Supply Chain Overview

1. Oriahnn: Composition and Manufacturing

Oriahnn’s complexity arises from its combination formulation of three active components: relugolix, estradiol, and norethindrone acetate. Each component requires specialized synthesis, purification, and formulation processes, often handled by different manufacturers before final assembly and packaging.

2. Active Pharmaceutical Ingredient (API) Suppliers

Relugolix API Suppliers:
Relugolix, the core component, is a small-molecule GnRH receptor antagonist developed by Takeda Pharmaceutical Company. Takeda is also responsible for the formulation and commercialization of Oriahnn.
- Takeda’s Role: Takeda oversees the procurement of relugolix API directly or through licensed manufacturers. Historically, Takeda collaborates with API suppliers in countries such as China and India to ensure supply stability.
- Key API Manufacturers:
- Suzhou Yuejiang Pharmaceutical Co., Ltd. (China): Known for producing relugolix API and related compounds, often supplying APIs for domestically marketed products in the Chinese market.
- Embopharma (India): An Indian API manufacturer with capabilities in hormone synthesis, likely a supplier or potential supplier for relugolix API, given India’s role in generic API manufacturing.
Estradiol API Suppliers:
Estradiol, a widely used hormone, is produced by numerous generic pharmaceutical manufacturers globally.
- Major Suppliers Include:
- Bayer AG: Historically supplied high-quality estradiol formulations.
- Dr. Reddy's Laboratories (India): Produces generic estradiol APIs for global export.
- Mitsubishi Tanabe Pharma (Japan): Also a supplier for premium-grade estrogen APIs.
Norethindrone Acetate API Suppliers:
Several manufacturers produce norethindrone acetate, often sourced from Indian and Chinese facilities.
- Prominent Suppliers:
- Hetero Labs (India): Known for producing steroid hormone APIs including norethindrone acetate.
- Mitsubishi Tanabe Pharma (Japan): Provides high-grade norethindrone acetate APIs.
- Xinhua Pharmaceutical (China): Expanding presence in hormone API production.

Formulation and Packaging

3. Final Formulation and Copacking

Takeda has established in-house and contracted facilities for the formulation and copackaging of Oriahnn:

Contract Manufacturing Organizations (CMOs):
Takeda partners with specialized CMOs globally to manage formulation, encapsulation, or copacking of biologic/dosage forms. These facilities must meet stringent cGMP standards, especially given the hormonal content and sensitive nature of the compound.
Packaging Partners:
Packaging involves blister packs and labeling adhered to regulatory standards. Takeda’s strategic partnerships include global packaging firms such as:
- Amcor Ltd.
- Schreiner Group
- Local regional packaging firms depending on the target market jurisdiction.

4. Distribution Channels

Takeda manages distribution either directly or through licensed partners in different regions, including North America, Europe, and Asia. The company maintains a robust supply chain ensuring regulatory compliance, efficient delivery, and shelf stability.

Key Global Suppliers and Market Dynamics

API Market Concentration:
The APIs for hormones like estradiol and norethindrone acetate are relatively commoditized, with a significant portion supplied by Indian and Chinese manufacturers. Despite the availability of generics, Takeda’s high-quality standards and regulatory requirements likely restrict the pool of approved suppliers for Oriahnn.
Regulatory Stringency & Quality Standards:
Takeda’s stringent Quality Assurance (QA) protocols ensure that only suppliers with GMP certification and proven traceability supply APIs. Recent regulatory trends in the US and Europe emphasize transparency and adherence to FDA and EMA standards, further narrowing supplier options.
Supply Chain Risks:
geopolitical tensions, pandemic disruptions, and geopolitical sanctions impact the supply chain. Diversification of API suppliers and the development of regional manufacturing hubs are ongoing strategies to mitigate these risks.

Recent Development and Strategic Outlook

Takeda’s strategic initiatives focus on securing reliable supply chains for Oriahnn by:

Expanding partnerships with API manufacturers in India and China.
Developing in-house API manufacturing capabilities.
Establishing regional manufacturing hubs for formulation and copackaging.

Moreover, patent expirations and the advent of generic alternatives could influence sourcing strategies, potentially allowing increased competition and lower costs in the future.

Conclusion

The supply chain for Oriahnn hinges on a complex network of high-quality API producers, formulation specialists, and packaging firms, predominantly based in India, China, and Japan. Takeda’s oversight and stringent quality controls ensure product integrity across markets.

Stability in API supply, geopolitical stability, regulatory compliance, and strategic partnerships remain paramount for uninterrupted Oriahnn production and distribution. Future developments may include vertical integration by Takeda and increased regional manufacturing investments to strengthen supply resilience.

Key Takeaways

API sourcing is concentrated in India and China, with Takeda partnering with multiple manufacturers to ensure supply security for relugolix, estradiol, and norethindrone acetate.
High regulatory standards limit API supplier pool, emphasizing quality, traceability, and GMP compliance.
Formulation and packaging are managed through global CMOs, with Takeda selecting partners based on quality standards.
Supply chain risks stem from geopolitical and pandemic-related factors, prompting strategic diversification and regional manufacturing plans.
Future trends suggest increased vertical integration and regional manufacturing, reducing dependency on external suppliers.

FAQs

1. Who are the primary API suppliers for Oriahnn?
Primary API suppliers include Suzou Yuejiang Pharmaceutical (China) for relugolix, and Indian manufacturers like Hetero Labs for norethindrone acetate, with established suppliers for estradiol globally.

2. Does Takeda manufacture any of the APIs in-house?
Takeda primarily sources APIs from qualified external suppliers but is actively developing in-house manufacturing capabilities to ensure supply security.

3. Are there risks associated with API suppliers from China and India?
Yes. Geopolitical tensions, regulatory changes, and supply disruptions pose risks. Diversification and regional manufacturing initiatives aim to mitigate such concerns.

4. How does regulatory oversight impact supplier selection?
High standards for GMP, traceability, and quality approval restrict supplier choices, emphasizing compliance with FDA, EMA, and other regional agencies’ requirements.

5. Could future patents or generics affect supply chain dynamics?
Potential patent expirations and increased generic competition may lead to additional suppliers, potentially lowering costs but heightening the need for strict quality oversight.

Sources:

Takeda Pharmaceutical Company. “Oriahnn (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) [Prescribing Information].” 2022.
Global API market reports—ICIS, Pharmaceutical Technology.
“API Manufacturing in India,” Indian Drug Manufacturers Association, 2021.
US FDA API inspections and compliance reports, 2022.
Industry analyses on hormonal API supply chains—EvaluatePharma, 2022.

Suppliers and packagers for ORIAHNN (COPACKAGED)