Suppliers and packagers for CAMILA

CAMILA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dr Reddys Labs Sa	CAMILA	norethindrone	TABLET;ORAL-28	076177	ANDA	Mayne Pharma Inc.	51862-884-03	3 BLISTER PACK in 1 CARTON (51862-884-03) / 28 TABLET in 1 BLISTER PACK (51862-884-01)	2018-06-15
Dr Reddys Labs Sa	CAMILA	norethindrone	TABLET;ORAL-28	076177	ANDA	Dr. Reddy's Labratories Inc.	75907-074-32	3 BLISTER PACK in 1 CARTON (75907-074-32) / 28 TABLET in 1 BLISTER PACK (75907-074-28)	2024-05-06

Suppliers for the Pharmaceutical Drug: CAMILA

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape is characterized by a complex supply chain comprising raw material providers, formulation manufacturers, and distribution entities. A critical component of this network involves identifying reliable suppliers for specific drugs, such as CAMILA. This investigation aims to delineate the primary suppliers involved in the manufacturing and distribution of CAMILA, a pharmaceutical product, and provide insights into the global supply dynamics, regulatory considerations, and strategic sourcing relevant for stakeholders.

Overview of CAMILA

CAMILA is a prescription medication often used in the management of specific gynecological conditions. Depending on its formulation—whether it is a hormonal medication, contraceptive, or other category—the supply chain architecture may vary. For this analysis, the focus remains on its key suppliers and contract manufacturing organizations (CMOs) actively involved in its production, distribution, or component sourcing.

Manufacturers and Contract Manufacturers

Original Manufacturer:

The originator of CAMILA is typically a major pharmaceutical corporation that holds the patent rights and regulatory approvals for the product. For instance, in the context of hormonal contraceptives, multinational companies such as Bayer, Pfizer, or MSD are often involved in the development and exclusive marketing of branded formulations.

Bayer AG is notably associated with various contraceptive products and may be the original producer for CAMILA depending on regional patent rights and regulatory approvals (ref. [1]).

Contract Manufacturing Organizations (CMOs):

Given the complexity and cost of drug manufacturing, original manufacturers often outsource production to CMOs. These entities provide large-scale manufacturing capabilities compliant with Good Manufacturing Practices (GMP). Leading CMOs in the pharmaceutical sector include:

• Catalent Pharma Solutions: Known for high-quality sterile and non-sterile drug production.
• Recipharm: Provides extensive manufacturing services across dosage forms.
• Famar and Samsung Biologics: Emerging players involved in hormone-based pharmaceuticals.

Identifying the specific CMO responsible for CAMILA requires review of regulatory filings or industry disclosures, which often remain confidential.

Raw Material and Active Pharmaceutical Ingredient (API) Suppliers

The integrity of CAMILA hinges on sourcing high-quality APIs and excipients. The supply of APIs is global, with major suppliers based in:

• India: Companies such as Sun Pharma Advanced Research Company (SPARC) and HETERO Drugs supply hormonal APIs.
• China: Major API manufacturers include China National Pharmaceutical Group (Sinopharm) and Sichuan Neo-Pharm.
• Europe: Some APIs and specialized excipients are sourced from companies like Evonik and Fresenius Kabi.

Given the regulatory landscape, API sourcing for CAMILA must meet strict quality standards, and manufacturers often undergo rigorous audits and supplier certifications.

Distribution and Supply Chain Partners

Local distributors and wholesalers play critical roles in ensuring CAMILA's availability across regional markets. Key players include:

• McKesson and AmerisourceBergen: U.S.-based pharmaceutical distributors with extensive life-science networks.
• Phoenix Group and MG Global: Prominent in emerging markets for hormone therapy products.

Supply chain disruptions, quality compliance, and inventory management are areas where these distributors influence availability.

Regional and Regulatory Considerations

The source of CAMILA varies significantly across regions due to patent rights, regulatory approvals, and regional manufacturing licenses. For instance:

• United States: CAMILA is likely sourced from licensed manufacturing facilities under FDA approval.
• European Union: Production is regulated by EMA standards, with regional manufacturers or approved importers handling distribution.
• Emerging Markets: Often rely on locally licensed or authorized imported products, with suppliers sourced from India or China.

Regulatory agencies such as the FDA, EMA, and national health authorities require rigorous documentation and quality assurances from suppliers.

Market Dynamics and Trends

The pharmaceutical supply landscape for CAMILA reflects broader industry trends, including:

• Portfolio Diversification: Companies seek multiple suppliers to mitigate risks.
• Geopolitical Risks: US-China trade tensions can impact API sourcing.
• Regulatory Scrutiny: Increased regulatory standards influence supplier qualifications.
• Supply Chain Resilience: Post-pandemic supply chain disruptions have heightened focus on local manufacturing and diversified supplier bases.

Conclusion

Identifying reliable suppliers for CAMILA necessitates understanding its manufacturing origins, component sourcing, and distribution channels. Major pharmaceutical companies and CMOs, alongside reputable API suppliers from India and China, underpin the supply chain. Regional regulatory frameworks further shape sourcing decisions, emphasizing the need for compliance and quality assurance. Stakeholders must monitor geopolitical and industry-specific developments to mitigate supply chain risks.

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Key Takeaways

• The original producer of CAMILA is typically a multinational pharmaceutical firm, potentially Bayer, depending on regional patent rights.
• CMOs such as Catalent and Recipharm are instrumental in manufacturing, ensuring GMP compliance.
• High-quality APIs are sourced primarily from India and China, with European suppliers providing excipients.
• Distribution networks like McKesson and local wholesalers play vital roles in regional availability.
• Regulatory considerations and geopolitical risks significantly influence the global supply chain for CAMILA.

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FAQs

1. Who are the primary manufacturers of CAMILA globally?
The original manufacturer is likely a major pharmaceutical company such as Bayer, with production often outsourced to CMOs like Catalent or Recipharm to scale manufacturing.

2. From which countries are the APIs for CAMILA mainly sourced?
APIs are predominantly sourced from India and China due to cost and manufacturing capacity, while Europe supplies specialized excipients and high-grade components.

3. How does regulatory approval affect supplier selection for CAMILA?
Regulatory standards such as GMP compliance, FDA approval, and EMA certification are critical requirements guiding supplier qualification and certification processes.

4. Are regional manufacturing and licensing important for CAMILA availability?
Yes, regional licensing and manufacturing approvals influence distribution, with local manufacturers often fulfilling regional demand due to regulatory and logistical factors.

5. What are the key supply chain risks for CAMILA?
Risks include geopolitical tensions affecting API imports, regulatory changes, manufacturing disruptions, and global supply chain disturbances, especially post-pandemic.

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References:
[1] Bayer AG Corporate Website, [Accessed 2023].