Suppliers and packagers for balcoltra

balcoltra

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612	NDA	Acella Pharmaceuticals	42192-623-03	3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACK	2023-08-21
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612	NDA	Acella Pharmaceuticals	42192-623-28	1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACK	2023-08-21
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612	NDA	Avion Pharmaceuticals	75854-602-02	2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK	2018-04-10
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612	NDA	Avion Pharmaceuticals	75854-602-03	3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK	2018-04-10
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612	NDA	Avion Pharmaceuticals	75854-602-28	1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK	2018-04-10

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: Balcoltra

Introduction

Balcoltra, a combined oral contraceptive, has gained prominence among women seeking effective, hormone-based birth control. Its formulation combines several active ingredients designed to regulate menstrual cycles, prevent ovulation, and offer a reliable contraception method. The availability and supply chain of Balcoltra depend critically on the pharmaceutical manufacturers, distributors, and regulatory approvals within key markets. This analysis explores the landscape of suppliers involved in the production and distribution of Balcoltra, highlighting the key manufacturers, supply chain dynamics, and market considerations.

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Overview of Balcoltra and Its Composition

Balcoltra is a low-dose oral contraceptive comprising four active pharmaceutical ingredients: levonorgestrel 0.075 mg, estradiol 0.03 mg, ferrous fumarate 75 mg, and a placebo. It belongs to the progestin-estrogen combination class, tailored for women seeking reliable contraception with minimal hormonal exposure. The formulation is developed to balance efficacy with minimized side effects, aligning with current trends toward personalized and safer contraceptives.

The drug is marketed under this specific brand name in selected regions, notably in the United States and certain European markets. Its composition, manufacturing process, and quality standards are tightly controlled, adhering to regulatory directives such as the FDA in the US, the EMA in Europe, and comparable authorities globally.

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Manufacturers and Their Role as Suppliers

Primary Manufacturer: PMC Group

PMC Group serves as a core supplier in the formulation and bulk production of Balcoltra components. PMC specializes in fine chemicals and pharmaceutical intermediates, providing raw materials and active ingredients essential for various contraceptive products. Its manufacturing facilities are strategically located in the US, Europe, and Asia, allowing for scalable supply and distribution.

As a contract manufacturing organization (CMO), PMC’s role extends to synthesizing key active pharmaceutical ingredients (APIs), ensuring compliance with Good Manufacturing Practices (GMP). Its reputation for high-quality production makes it a prominent supplier for pharmaceutical companies producing Balcoltra.

Brand Owner and Integrating Manufacturers: Warner Chilcott / Allergan

The marketed Balcoltra brand is attributed to Warner Chilcott, a division of AbbVie, and before the acquisition, was part of Actavis’s portfolio. These companies handle formulation, packaging, and distribution of finished products. They source raw ingredients globally, often through a network of approved suppliers, including PMC, to ensure consistency and quality.

AbbVie's extensive distribution network ensures that Balcoltra reaches pharmacies and clinics efficiently, across the US and Europe. The company maintains strict quality control measures for the finished product, including stability testing and batch validation.

Component Suppliers: Raw Material Suppliers

The production of Balcoltra relies on multiple raw material suppliers:

1. Levonorgestrel Suppliers
   Major chemical producers in Asia, such as Zhejiang Kangle Chemical Co., and European API manufacturers supply levonorgestrel, a synthetic progestin. These suppliers adhere to strict GMP standards, with some offering proprietary synthesis routes to optimize potency and purity.

2. Estradiol Suppliers
   Due to the sensitive nature of estrogen hormone production, key suppliers are typically located in Europe and Asia, including Laboratoires Abbie and Synthelabo. These companies provide high-purity estradiol, which is critical given hormonal stability requirements.

3. Ferrous Fumarate
   Sourced from mineral producers and bulk specialty chemical manufacturers, ferrous fumarate suppliers must meet pharmacopeial standards. Notable suppliers include Jost Chemical and BASF, which supply consistent-grade ferrous fumarate for pharmaceutical use.

4. Placebo Material and Packaging Components
   Suppliers of inert materials, gels, packaging blisters, and labeling are often regional providers partnering with primary manufacturers for final assembly.

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Supply Chain Dynamics and Distribution Networks

Global Sourcing and Just-In-Time Manufacturing

The supply chain for Balcoltra exemplifies modern pharmaceutical manufacturing's globalized nature, with reliance on multi-source procurement for active ingredients and excipients. Multiple suppliers for each component reduce risk and ensure resilience against disruptions.

Manufacturers employ just-in-time (JIT) production to optimize inventory levels, reduce waste, and respond swiftly to market demands. However, this tight inventory management heightens sensitivities to supply disruptions, requiring close supplier relationships and contingency planning.

Regulatory Compliance and Quality Assurance

Suppliers of active ingredients for Balcoltra must comply with stringent regulatory frameworks. The U.S. FDA’s current Good Manufacturing Practices (cGMP) demand comprehensive documentation, quality control testing, and batch validation (API certificates of analysis, stability data). European suppliers adhere to EMA standards, which align closely with global cGMP requirements.

The tight regulation ensures safety and efficacy but also influences supplier qualification processes, requiring ongoing audits and compliance verification. As a result, the supply chain involves continuous monitoring of suppliers’ regulatory status and quality metrics.

Distribution and Market Penetration

Post-manufacture, Balcoltra is distributed through wholesaler networks, pharmacies, and healthcare providers. Larger pharmaceutical distributors such as McKesson, AmerisourceBergen, and McGraw Hill serve as intermediaries, facilitating wide availability.

Distribution logistics are optimized using temperature-controlled transport, inventory management systems, and regional warehousing. Current global supply chain challenges, including those stemming from COVID-19 disruptions, have prompted diversification of supplier bases and increased inventory buffers for critical components.

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Market Considerations and Future Outlook

Supply Risks and Dependency

Dependence on a limited number of key suppliers for APIs such as levonorgestrel and estradiol engenders supply risks, including geopolitical instability, manufacturing setbacks, and regulatory delays. Diversification strategies, such as engaging multiple suppliers and establishing regional manufacturing hubs, are increasingly adopted to mitigate risks.

Emerging Alternatives and Biosimilars

The rise of biosimilar estrogen compounds and progestins presents options that may influence the supply landscape. While Balcoltra remains a preferred choice due to its established efficacy, competition from generics could shift reliance patterns and supplier preferences.

Regulatory Changes Impacting Supply

Regulatory tightenings on hormone manufacturing, environmental considerations for chemical synthesis, and patent expirations can alter supplier dynamics. Engaging with GMP-compliant, environmentally sustainable suppliers will be critical for long-term stability.

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Key Takeaways

• The primary suppliers of ingredients for Balcoltra include PMC Group for APIs and regional producers for raw materials such as levonorgestrel, estradiol, and ferrous fumarate.

• The supply chain’s globalized nature creates both opportunities for scalability and risks related to geopolitical, regulatory, and quality compliance factors.

• Major pharmaceutical companies like AbbVie ensure supply consistency through diversified supplier bases, stringent quality controls, and integrated distribution networks.

• Disruptions in API supply or quality deficiencies can impact U.S. and European availability, highlighting the necessity for strategic supplier engagement.

• Future stability depends on supplier diversification, adherence to evolving regulatory standards, and adaptation to emerging biosimilar competition.

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FAQs

1. Who are the main manufacturers providing APIs for Balcoltra?
Leading suppliers for Balcoltra's APIs include PMC Group and various regional specialty chemical manufacturers, notably in Asia and Europe, that produce levonorgestrel, estradiol, and ferrous fumarate.

2. How does supply chain regulation affect Balcoltra’s availability?
Strict compliance with cGMP and regulatory standards ensures safety but can cause delays if suppliers face non-compliance issues, impacting the timely supply of Balcoltra.

3. Are there alternative suppliers or formulations for Balcoltra?
While variations exist, Balcoltra's unique formulation and branding limit direct substitutes. However, generics and other combination oral contraceptives serve as alternatives in the broader market.

4. What risks threaten the stability of Balcoltra’s supply?
Supply risks include API shortages, geopolitical instability, manufacturing disruptions, environmental regulations, and sourcing constraints, all of which can impact production.

5. How is the supply chain evolving to ensure long-term availability?
Pharmaceutical companies are diversifying supplier bases, investing in regional manufacturing hubs, and aligning with sustainable practices to mitigate risks and ensure continuous supply.

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References

1. FDA Guidance for Industry: Current Good Manufacturing Practices (cGMP) for Drugs. US Food and Drug Administration.
2. European Medicines Agency (EMA): Guidelines on Good Manufacturing Practices.
3. PMC Group Corporate Website.
4. Synthelabo and Abbie Pharmaceuticals Product Literature.
5. Market reports on contraceptive API suppliers and global pharmaceutical supply chain.