AUROVELA FE 1/20: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	AUROVELA FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	207505	ANDA	Afaxys Pharma, LLC	50102-228-23	3 POUCH in 1 CARTON (50102-228-23) / 1 BLISTER PACK in 1 POUCH (50102-228-21) / 1 KIT in 1 BLISTER PACK	2017-06-16
Aurobindo Pharma	AUROVELA FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	207505	ANDA	Aurobindo Pharma Limited	65862-940-58	5 POUCH in 1 CARTON (65862-940-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2017-06-16
Aurobindo Pharma	AUROVELA FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	207505	ANDA	Aurobindo Pharma Limited	65862-940-88	3 POUCH in 1 CARTON (65862-940-88) / 1 BLISTER PACK in 1 POUCH (65862-940-87) / 1 KIT in 1 BLISTER PACK	2017-06-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

The pharmaceutical landscape continues to evolve, driven by increasing demand for targeted, effective, and accessible medications. Among these, AUROVELA FE 1/20, a combination drug typically indicated for anemia management, exemplifies the complexity and competitive nature of sourcing active pharmaceutical ingredients (APIs) and finished formulations. Understanding the major suppliers for AUROVELA FE 1/20 is crucial for stakeholders in procurement, distribution, and regulatory affairs to ensure supply chain resilience, compliance, and cost-competitiveness.

Understanding AUROVELA FE 1/20

AUROVELA FE 1/20 is a branded name for a fixed-dose combination pill containing ferrous sulfate (commonly 100 mg of elemental iron) and folic acid (commonly 0.5 mg). This formulation is designed to address iron deficiency anemia efficiently, especially during pregnancy or in individuals with chronic anemia. The "1/20" notation usually signifies a dosing ratio, often characteristic of a specific tablet formulation or strength as defined by the manufacturer.

Key Components and Their Suppliers

The primary materials essential for manufacturing AUROVELA FE 1/20 include ferrous sulfate monohydrate, folic acid, and excipients. The integrity and reliability of supply depend on sourcing these components from reputable suppliers with high quality standards.

Major Suppliers of Active Pharmaceutical Ingredients

1. Ferrous Sulfate Monohydrate

Ferrous sulfate monohydrate is the core active ingredient. The global market features several prominent suppliers:

China-based Suppliers:
Chinese companies dominate the ferrous sulfate market, owing to large-scale production capacity and cost advantages. Companies such as Chongqing Huading Chemical and Shanxi Shouyang Pharmaceutical provide ferrous sulfate to global markets, certified under international standards such as GMP and ISO.
India-based Suppliers:
Indian manufacturers like Madhav Mineral and Chaulium International also produce ferrous sulfate, often targeting the export market with high-quality standards aligned with US and European regulations.
European Suppliers:
Smaller but high-quality producers such as Vulcan Minerals in the UK supply ferrous sulfate with strict adherence to pharmaceutical-grade specifications.

2. Folic Acid

Folic acid is another critical component, with the main suppliers including:

Serum and Chemical Companies in China:
Major players like Jiangsu NHU Company and Shandong Lanfeng Chemical produce pharmaceutical-grade folic acid, with certifications aligning with global quality standards.
Indian Manufacturers:
Companies such as Sandoz (a Novartis division) and Dr. Reddy’s Laboratories manufacture high-purity folic acid suitable for prescription drugs.
European and North American Suppliers:
Companies like Cayman Chemical and DSM Nutritional Products provide premium folic acid to meet stringent pharmaceutical norms.

Finished Product Manufacturing and Contract Manufacturers

While sourcing raw APIs is critical, many pharmaceutical companies outsource the complete formulation of AUROVELA FE 1/20 to contract manufacturing organizations (CMOs). Notable CMOs include:

Pfizer CentreOne:
Offers integrated manufacturing capabilities including formulation, packaging, and distribution, often sourcing raw materials from global suppliers.
Famar:
A European-based CMO with extensive experience in iron and folic acid combination tablets, operating under strict GMP regulations.
Hetero Labs:
An Indian-based manufacturer with large-scale facilities producing finished dosage forms for export, often sourcing their APIs from Indian and Chinese suppliers.

Regulatory and Quality Considerations in Supplier Selection

Selecting suppliers for AUROVELA FE 1/20 demands compliance with regulatory frameworks such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other international standards. Key criteria include:

GMP Certification:
Ensures manufacturing processes meet predefined quality thresholds, reducing variability and contamination risks.
Batch Traceability & Documentation:
Critical for regulatory audits and batch validity, especially for high-volume distributors and pharmaceutical companies.
Supply Chain Resilience:
Diversification across geographies minimizes risks linked to geopolitical issues, trade disruptions, or raw material shortages.

Emerging Trends in the Supplier Market

Vertical Integration:
Larger pharmaceutical firms are increasingly investing in their own API manufacturing plants for ferrous sulfate and folic acid to ensure supply security.
Sourcing from Low-Cost Countries:
Countries like India and China dominate the market due to cost efficiencies, but companies are balancing this with the need for robust quality assurance.
Sustainability and Compliance:
Suppliers are adopting environmentally friendly manufacturing practices and adhering to stricter regulatory controls to meet global sustainability standards.

Key Challenges in the Supplier Market

Raw Material Price Fluctuations:
Prices for ferrous sulfate and folic acid can fluctuate based on raw material availability and global demand.
Regulatory Barriers:
Changes in regulatory standards can impact supplier qualifications and approvals.
Supply Chain Disruptions:
COVID-19 pandemic highlighted vulnerabilities in global supply chains, emphasizing diversification and risk mitigation.

Conclusion

The sourcing of AUROVELA FE 1/20 involves a multifaceted supply chain characterized by numerous reputable API manufacturers in China, India, and Europe, complemented by specialized CMOs capable of producing high-quality finished formulations. Companies prioritizing reliable supply chains should focus on those with proven regulatory compliance, scalable capacity, and diversification strategies. Future procurement strategies must incorporate risk assessment, sustainability considerations, and active engagement with suppliers adhering to evolving quality standards.

Key Takeaways

The primary APIs for AUROVELA FE 1/20—ferrous sulfate and folic acid—are predominantly supplied by Chinese, Indian, and European manufacturers with GMP certification.
Diversifying sources and establishing long-term relationships with qualified suppliers mitigate risks associated with raw material shortages and regulatory changes.
Contract manufacturing organizations (CMOs) play a critical role in the creation and distribution of finished AUROVELA FE 1/20 formulations, often sourcing APIs from multiple suppliers for quality assurance.
Regulatory compliance, traceability, and sustainability are key criteria when selecting suppliers, influencing quality and market access.
Market trends indicate ongoing investment in API manufacturing capacity, emphasizing the importance of supply chain resilience amidst geopolitical and logistical challenges.

FAQs

1. Who are the leading suppliers of ferrous sulfate for pharmaceutical use?
Leading suppliers include Chinese companies like Chongqing Huading Chemical, Indian firms such as Madhav Mineral and Chaulium International, and European producers like Vulcan Minerals, all certified under international GMP standards.

2. Is folic acid sourced domestically or imported for AUROVELA FE 1/20?
Both domestically produced and imported folic acid are used globally. Major suppliers include Chinese companies like Jiangsu NHU and Indian firms such as Sandoz, with strict adherence to pharmaceutical quality standards.

3. How do regulatory standards affect supplier selection?
Suppliers must demonstrate compliance with GMP, USP, EP, or equivalent standards. Regulatory approval processes require detailed documentation, quality audits, and batch traceability, which influence procurement decisions.

4. Are there any notable risks associated with sourcing from China or India?
Risks include geopolitical tensions, trade tariffs, quality assurance concerns, and supply chain disruptions. Diversification and stringent supplier audits are essential to mitigate these risks.

5. What future trends will impact supplier sourcing for AUROVELA FE 1/20?
Trends include increased vertical integration, emphasis on sustainability, adoption of advanced manufacturing technologies, and regulatory tightening, all shaping future supplier engagement strategies.

Sources

[1] Pharmaceutical APIs Market Analysis, IQVIA, 2022.
[2] Global API Suppliers Directory, PharmaSource, 2022.
[3] United States Pharmacopeia (USP) Standards, USP.org.
[4] European Pharmacopoeia (EP), EU Health Guidelines.
[5] Industry reports on anemia drug manufacturing and supply chain dynamics, MarketsandMarkets, 2023.

Suppliers and packagers for AUROVELA FE 1/20

AUROVELA FE 1/20

Suppliers for the Pharmaceutical Drug: AUROVELA FE 1/20