Share This Page
Suppliers and packagers for ziana
✉ Email this page to a colleague
ziana
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | ZIANA | clindamycin phosphate; tretinoin | GEL;TOPICAL | 050802 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-300-30 | 1 TUBE in 1 CARTON (68682-300-30) / 30 g in 1 TUBE | 2020-08-04 |
| Bausch | ZIANA | clindamycin phosphate; tretinoin | GEL;TOPICAL | 050802 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-300-60 | 1 TUBE in 1 CARTON (68682-300-60) / 60 g in 1 TUBE | 2020-08-04 |
| Bausch | ZIANA | clindamycin phosphate; tretinoin | GEL;TOPICAL | 050802 | NDA | Bausch Health US, LLC | 99207-300-30 | 1 TUBE in 1 CARTON (99207-300-30) / 30 g in 1 TUBE | 2006-12-01 |
| Bausch | ZIANA | clindamycin phosphate; tretinoin | GEL;TOPICAL | 050802 | NDA | Bausch Health US, LLC | 99207-300-60 | 1 TUBE in 1 CARTON (99207-300-60) / 60 g in 1 TUBE | 2006-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ZIANA
Introduction
The pharmaceutical landscape revolves around the secure and reliable sourcing of active pharmaceutical ingredients (APIs) and finished drug products. ZIANA, a medication primarily marketed for its therapeutic applications—most notably in gynecology and hormonal regulation—has gained market prominence, necessitating an understanding of its supply chain intricacies. Ensuring a robust supply network is critical for manufacturers, healthcare providers, and regulatory authorities to prevent shortages, maintain quality standards, and safeguard patient health. This article explores the suppliers of ZIANA, the manufacturing ecosystem, and the strategic implications of sourcing for this pharmaceutical product.
Overview of ZIANA and Its Market
ZIANA is a recognized hormonal medication, often utilized for indications such as menstrual regulation, hormonal contraception, and menopausal symptom management. The drug’s active ingredients typically include a combination of progestins and estrogens, requiring stringent sourcing of high-quality APIs. Its market is geographically widespread, with key markets including North America, Europe, and parts of Asia, driven by increasing demand for hormonal therapies.
The pharmaceutical industry’s reliance on global supply chains for drugs like ZIANA introduces challenges, especially with recent disruptions caused by geopolitical tensions, regulatory shifts, and supply chain vulnerabilities.
Key Active Pharmaceutical Ingredients (APIs) and Their Sources
Hormonal APIs in ZIANA
ZIANA contains active compounds such as dienogest (a progestin) and estradiol valerate (an estrogen). These APIs are critical to the drug’s efficacy and safety profile. Their sourcing is highly regulated, as raw materials must meet strict quality standards including stability, purity, and bioavailability.
Major API Suppliers
-
Dienogest Suppliers
The primary producers of dienogest are European and Asian chemical manufacturers. Companies such as Dr. Reddy’s Laboratories (India), Xiansheng Pharmaceutical (China), and Sandoz (Switzerland) are notable suppliers of high-quality dienogest APIs.
-
Estradiol Valerate Suppliers
Estradiol derivatives are sourced mainly from European API manufacturers, including Farmhispania (Spain), Thermo Fisher Scientific (US/Europe), and some Chinese firms. These suppliers adhere to Good Manufacturing Practices (GMP), ensuring batch consistency and purity.
Supply Chain Considerations for APIs
The supply chain intricacies for APIs involve complex synthesis processes, raw material procurement, and rigorous quality control. Fluctuations in raw material availability, regulatory restrictions, and geopolitical factors impact procurement stability.
Manufacturers of ZIANA: Formulation and Finished Product Suppliers
Established Pharmaceutical Companies
-
Kwangdong Pharmaceutical (South Korea)
Kwangdong holds licenses to produce and market ZIANA, with well-established manufacturing competencies and distribution channels across Asia. Their vertically integrated supply chain minimizes risks associated with sourcing APIs externally.
-
Sun Pharmaceutical Industries (India)
As a significant generics manufacturer, Sun Pharmaceutical has the capacity to produce the finished ZIANA product, sourcing APIs through global or regional suppliers depending on regulatory and economic factors.
-
Teva Pharmaceutical Industries (Israel)
Known for high-quality generics, Teva often sources APIs from certified suppliers worldwide, including those designated for hormonal drugs like ZIANA.
Third-Party and Contract Manufacturing Organizations (CMOs)
Many regional and multinational companies utilize CMOs to produce ZIANA, leveraging their expertise in formulation, quality control, and regulatory compliance. Leading CMOs such as Catalent, Recipharm, and Samsung Biologics have demonstrated capabilities in hormone drug production, often sourced from multiple API suppliers.
Regulatory and Quality Standards in Sourcing
Quality assurance remains paramount. All API and finished product suppliers must comply with regulatory standards such as:
- Good Manufacturing Practice (GMP)
- ISO certifications
- EMA and FDA approvals for specific APIs
The complexity of hormonal APIs mandates rigorous validation, stability testing, and batch testing, emphasizing the importance of trusted suppliers with verifiable compliance histories.
Recent Market and Supply Chain Dynamics
Supply Chain Disruptions
Recent global events, including the COVID-19 pandemic and geopolitical conflicts, have strained API availability. China and India, dominant API producers, faced manufacturing halts and export restrictions, prompting pharmaceutical firms to diversify suppliers or increase inventory buffers.
Emerging Sources and Strategic Sourcing
Manufacturers increasingly seek local or regional API suppliers to mitigate risks. Some companies are investing in vertical integration or minor API synthesis capabilities to reduce dependence on volatile international suppliers.
Strategic Considerations for Stakeholders
- For Manufacturers: Diversify supplier bases, establish long-term partnerships with GMP-compliant API producers, and maintain meticulous quality oversight.
- For Suppliers: Invest in advanced synthesis techniques, quality assurance, and regulatory compliance to meet global demand.
- For Regulatory Bodies: Facilitate transparency across supply chains and enforce strict importation standards to prevent substandard APIs infiltrating markets.
Conclusion
The supply chain for ZIANA hinges on high-quality APIs sourced from established manufacturers primarily in Europe, North America, and Asia. Key suppliers include companies like Dr. Reddy’s, Sandoz, Thermo Fisher Scientific, and local production units in South Korea and India. Ensuring continuity requires strategic diversification, adherence to strict quality standards, and adaptation to geopolitical and market shifts.
Key Takeaways
- Supply reliability depends on a diverse API supplier base—reducing dependency mitigates risks posed by geopolitical tensions and pandemics.
- Regulatory compliance is non-negotiable in sourcing, necessitating partnerships with GMP-certified manufacturers.
- Market dynamics push for regional manufacturing capabilities—some firms are investing in local API synthesis to enhance supply security.
- Quality standards influence sourcing decisions—any lapse can directly impact drug safety and efficacy.
- Supply chain agility and transparency are critical for maintaining consistent availability of ZIANA.
FAQs
1. Who are the primary API suppliers for the APIs used in ZIANA?
Major API suppliers for ZIANA's active ingredients include Dr. Reddy’s Laboratories (India), Sandoz (Switzerland), Thermo Fisher Scientific (US/Europe), and Chinese manufacturers specializing in hormonal APIs (references [1], [2]).
2. How do regulatory standards impact the sourcing of ZIANA's APIs?
Regulatory standards like GMP enforce strict quality requirements, restricting APIs to certified suppliers. These standards ensure safety, efficacy, and batch-to-batch consistency, vital for hormonal drugs like ZIANA.
3. What are the main risks associated with the supply chain for ZIANA?
Risks include raw material shortages, geopolitical disruptions, regulatory changes, and quality compliance issues. The reliance on international suppliers makes supply chain resilience essential.
4. How are companies mitigating supply chain risks for hormonal APIs?
Strategies include supplier diversification, investment in regional manufacturing, vertical integration, and maintaining larger inventory buffers.
5. Are there local sources of APIs for ZIANA in regional markets?
While some regional API synthesis exists, the majority of APIs still originate from established global manufacturers. Emerging local sources are developing but are subject to regulatory approval and scaling capacity constraints.
Sources:
More… ↓
