Suppliers and packagers for generic pharmaceutical drug: BIMATOPROST

BIMATOPROST

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911	NDA	Allergan, Inc.	0023-9652-01	1 IMPLANT in 1 POUCH (0023-9652-01)	2020-03-04
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911	NDA	Allergan, Inc.	0023-9652-03	1 IMPLANT in 1 POUCH (0023-9652-03)	2020-03-04
Alembic	BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	210263	ANDA	Alembic Pharmaceuticals Limited	46708-507-05	1 BOTTLE in 1 CARTON (46708-507-05) / 5 mL in 1 BOTTLE	2019-04-12

Suppliers for the Pharmaceutical Drug: Bimatoprost

Last updated: July 27, 2025

Introduction

Bimatoprost is a synthetic prostaglandin analog primarily used in ophthalmology to reduce intraocular pressure in conditions such as glaucoma and ocular hypertension. It is also marketed under the brand names Lumigan, Latisse, and others. As a widely prescribed medication, understanding its supplier landscape is vital for pharmaceutical companies, healthcare providers, and supply chain stakeholders. This article provides a comprehensive analysis of key suppliers for Bimatoprost, examining manufacturing sources, regulatory considerations, and market dynamics that influence its distribution globally.

Manufacturers Producing Bimatoprost

Major Pharmaceutical Companies

1. AbbVie Inc.
   AbbVie is the original developer of Bimatoprost, marketing it as Lumigan for glaucoma treatment and Latisse for eyelash growth. The company supplies Bimatoprost directly in several markets, leveraging its robust manufacturing infrastructure and regulatory approvals. The proprietary formulation, backed by extensive research, positions AbbVie as the primary source for many regions.

2. Sun Pharmaceutical Industries Ltd.
   Sun Pharma is a prominent generic manufacturer of Bimatoprost. The company produces both branded and generic versions, following stringent Good Manufacturing Practices (GMP). Sun Pharma's manufacturing facilities are compliant with international standards, allowing it to supply Bimatoprost in multiple markets, particularly in developing economies.

3. Sandoz (Novartis Group)
   As a leading generic pharmaceutical company, Sandoz offers Bimatoprost in various formulations. Its extensive global network and focus on biosimilars and generics make it a significant supplier, especially in regions with high demand for cost-effective glaucoma therapies.

4. Ajanta Pharma
   Ajanta Pharma manufactures Bimatoprost as part of its ophthalmic portfolio, primarily distributing within Asia, Africa, and some Middle Eastern markets. Their manufacturing is compliant with international GMP standards, and they have a reputation for affordable generics.

5. Macleods Pharmaceuticals
   Based in India, Macleods produces Bimatoprost and supplies it across Asia, Africa, and parts of Latin America. Its manufacturing facilities are certified by global regulators and focus on high-volume, low-cost production.

Emerging and Regional Suppliers

• Farmaco Ltd. (Latin America)
  Provides Bimatoprost in Latin American markets, emphasizing affordability and regional regulatory compliance.

• Intas Pharmaceuticals
  An Indian-based manufacturer offering Bimatoprost for various markets. Intas emphasizes quality manufacturing aligned with international standards.

• BioReperia
  Specialized in biosimilar and generic ophthalmic drugs, supplying Bimatoprost primarily in Europe.

Contract Manufacturers and Outsourcing

Many pharmaceutical companies outsource Bimatoprost manufacturing to third-party Contract Manufacturing Organizations (CMOs). Notable CMOs operating in this space include Ajinomoto, Formosa Laboratories, and Alcami, which provide bulk production services for branded and generic Bimatoprost.

Regulatory and Licensing Factors

For supply continuity and market approval, manufacturers must comply with stringent regulatory standards set by agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and local health authorities. These regulatory approvals certify manufacturing quality and influence which companies can be primary suppliers in specific regions.

Additionally, patent status significantly impacts supply channels. Currently, Bimatoprost’s original patents have expired in many regions, enabling generic manufacturers to produce and market their versions legally. However, some regions still maintain patent protections, limiting the supplier pool and influencing market competition.

Market Dynamics and Supply Chain Considerations

Global Distribution and Local Production

The supply of Bimatoprost relies heavily on regional manufacturing hubs. India and China lead as major manufacturing centers due to cost advantages and robust API (Active Pharmaceutical Ingredient) production capabilities. Many international companies source APIs from these markets, extricating themselves from sole reliance on regional producers.

API Supply and Raw Material Sources

The active pharmaceutical ingredient (API) for Bimatoprost is synthesized through complex chemical processes involving multiple chemical intermediates. Suppliers for Bimatoprost API include companies such as:

• Dongling Pharmaceutical (China)
• Shandong Topscience (China)
• ALK-Abelló (Europe)

These API suppliers form the backbone of the Bimatoprost manufacturing supply chain, supporting both branded and generic formulations.

Supply Chain Risks

Global disruptions—such as regulatory changes, geopolitical tensions, or pandemics—affect supply stability. For example, the COVID-19 pandemic led to temporary shortages in ophthalmic drugs, emphasizing the need for diversified supplier bases and regional manufacturing capabilities.

Future Trends in Bimatoprost Suppliers

• Increased regional manufacturing to mitigate supply chain disruptions and meet regional regulatory requirements.
• Expansion of generic manufacturing due to patent expirations, resulting in increased supplier competition.
• Development of biosimilar versions and innovator reformulations, potentially impacting the supplier landscape.

Conclusion

The global supply landscape for Bimatoprost is characterized by a mix of established pharmaceutical giants, regional generics manufacturers, and contract manufacturing organizations. Key players like AbbVie, Sun Pharma, and Sandoz dominate the space, supported by an extensive API supply chain predominantly from Chinese and Indian API producers. Manufacturers must navigate complex regulatory environments, patent landscapes, and supply chain risks to ensure uninterrupted availability. The ongoing expansion of generic manufacturers and regional production hubs suggests a diversifying and resilient supply ecosystem.

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Key Takeaways

• Leading suppliers include AbbVie (original innovator), Sun Pharma, Sandoz, Ajanta Pharma, and Macleods.
• API production from Chinese and Indian companies underpins global supply chains; diversification reduces dependency risks.
• Regulatory approvals from agencies like the FDA and EMA influence supplier access and market approval.
• Market dynamics favor increased generic competition and regional manufacturing to enhance supply resilience.
• Supply chain risks necessitate strategic sourcing and diversified manufacturing locations to ensure consistent availability.

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FAQs

1. Who is the original manufacturer of Bimatoprost?
AbbVie Inc. developed and launched Bimatoprost as Lumigan and Latisse, maintaining control over its proprietary formulations.

2. Are there generic versions of Bimatoprost available globally?
Yes, numerous generic manufacturers—mainly from India and China—produce Bimatoprost, especially following patent expirations in many regions.

3. What are the main sources of API for Bimatoprost?
Chinese and Indian API producers, such as Dongling Pharmaceutical and Shandong Topscience, supply the active ingredient used by pharmaceutical companies worldwide.

4. How does patent status affect Bimatoprost supply?
Patent expirations in many jurisdictions have facilitated increased generic manufacturing, expanding supplier options and reducing prices.

5. What risks might impact the supply of Bimatoprost?
Supply disruptions can result from regulatory changes, geopolitical tensions, pandemic-related manufacturing issues, or API shortages.

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Sources

1. [1] U.S. Food and Drug Administration. “FDA Approved Drugs Database.”
2. [2] European Medicines Agency. “Bimatoprost Summary of Product Characteristics.”
3. [3] IMS Health Data. “Global Ophthalmic Market Overview.”
4. [4] Industry Reports. “Global API Market for Ophthalmic Drugs;” MarketLine, 2022.
5. [5] Company Websites: AbbVie, Sun Pharmaceutical, Sandoz, Ajanta Pharma, Macleods Pharmaceuticals.