DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Try for Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Labs Fl Inc	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	205811	ANDA	Actavis Pharma, Inc.	0591-2132-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2132-01)	2019-06-21
Bionpharma	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	217000	ANDA	Bionpharma Inc.,	69452-206-20	100 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-206-20)	2023-12-11
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA	Duchesnay USA, Inc.	55494-100-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)	2013-05-15
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA	Duchesnay USA, Inc.	55494-100-99	12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)	2013-05-15
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA AUTHORIZED GENERIC	Analog Pharma	70505-100-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE (70505-100-10)	2018-11-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

The pharmaceutical market for doxylamine succinate and pyridoxine hydrochloride, a combination widely used to manage nausea and vomiting during pregnancy, is characterized by a diverse network of manufacturers, suppliers, and distributors. This report examines the global supply chain, regulatory frameworks, pricing strategies, and emerging trends shaping the availability of this antiemetic formulation. Key players such as Matins Pharma, A.D. Pharmaceuticals, and Apotex Inc. dominate regional markets, while platforms like PharmaCompass facilitate connections between buyers and certified suppliers[1][2][11]. Regulatory compliance, particularly adherence to Good Manufacturing Practices (GMP) and certifications like WHO-GMP, remains a critical factor in supplier selection[3][8][12]. The analysis also explores franchise models, formulation innovations, and challenges in raw material sourcing, providing actionable insights for stakeholders navigating this competitive landscape.

Therapeutic Applications and Market Demand

Clinical Indications and Patient Populations

Doxylamine succinate, an antihistamine, and pyridoxine hydrochloride (vitamin B6) are combined to address nausea and vomiting in pregnancy (NVP), a condition affecting approximately 70% of expectant mothers[7][12]. The formulation’s efficacy in mitigating morning sickness has been validated by organizations like the American College of Obstetricians and Gynecologists, which recommends it as a first-line therapy[7][10]. Beyond obstetric use, off-label applications include postoperative nausea and chemotherapy-induced vomiting, though these remain less common[5][12].

Global Prevalence and Market Dynamics

The demand for this combination is driven by rising pregnancy rates in emerging economies and increased awareness of NVP management. India, for instance, hosts over 20 manufacturers, including Matins Pharma and Somacare, catering to domestic needs and export markets[1][6][12]. In North America, branded products like Bonjesta and Diclegis hold formulary coverage under insurers such as Cigna, ensuring steady demand despite generic competition[5][10]. Market analysts project a 4.8% annual growth rate through 2030, fueled by expanding healthcare access in Asia-Pacific regions[6][8].

Key Manufacturers and Branded Products

Leading Suppliers in India

India’s pharmaceutical sector dominates generic production, with companies like Matins Pharma offering Welvom Tablets (doxylamine succinate 10mg + pyridoxine HCl 10mg + folic acid 2.5mg) under PCD franchise models[1]. Amagen India Life Sciences and Habitare Pharma Pvt. Ltd. provide competitive pricing, with strips of 10 tablets retailing at ₹105–₹800 ($1.25–$9.50)[6]. These suppliers emphasize WHO-GMP compliance and direct-to-distributor partnerships to minimize costs[1][12].

International Brands and Regulatory Approvals

In contrast, Apotex Inc.’s Apo-Doxylamine/B6, approved by Health Canada, exemplifies stringent regulatory adherence, with delayed-release tablets ensuring sustained therapeutic effects[11]. Bonjesta (20mg/20mg) and Diclegis (10mg/10mg), marketed in the U.S., undergo rigorous FDA scrutiny, with annual quotas capped at 360–720 tablets per patient to prevent misuse[5][7]. JoinHub Pharma further illustrates global reach, exporting EU-GMP-certified delayed-release tablets to 15 countries[10].

Regulatory Compliance and Quality Standards

Good Manufacturing Practices (GMP)

Suppliers must comply with GMP guidelines to ensure product safety and efficacy. Matins Pharma, for instance, emphasizes “100% quality assurance” through state-of-the-art facilities audited by WHO and Indian regulatory bodies[1][12]. Similarly, PharmaCompass verifies manufacturers’ USDMF (US Drug Master File) and CEP (Certification of Suitability) statuses, enabling buyers to identify compliant partners[3][8].

Regional Regulatory Variations

While the U.S. and EU mandate bioavailability studies for delayed-release formulations, India’s CDSCO (Central Drugs Standard Control Organization) permits abbreviated pathways for generic equivalents[5][10][12]. This disparity impacts export strategies; for example, Somacare prioritizes WHO prequalification to access African markets, whereas JoinHub Pharma aligns with EMA (European Medicines Agency) standards for European distribution[10][12].

Global Supply Chain and Distribution Networks

Raw Material Sourcing and API Production

Doxylamine succinate API (Active Pharmaceutical Ingredient) manufacturers, such as those listed on PharmaCompass, source intermediates from China and India, where production costs are 30–40% lower than in Western nations[3][8]. Pyridoxine hydrochloride, however, faces supply chain vulnerabilities due to vitamin B6’s reliance on corn-derived substrates, which are susceptible to agricultural price fluctuations[6][12].

Logistics and Cold Chain Management

Temperature-controlled transport is critical for maintaining pyridoxine stability, particularly for extended-release tablets. Suppliers like Healsglobe Exports employ IoT-enabled packaging to monitor real-time conditions during transit, reducing spoilage rates by 15%[6][10]. Conversely, smaller distributors in rural India rely on insulated containers, limiting their reach to urban centers[1][6].

Pricing Strategies and Market Competitiveness

Cost Breakdown and Profit Margins

A strip of 10 tablets typically retails for ₹105–₹190 ($1.25–$2.25) in India, with manufacturers netting 40–50% margins after accounting for API procurement (₹35/strip), labor (₹20/strip), and regulatory fees (₹10/strip)[1][6]. In contrast, U.S. brands like Bonjesta are priced at $120–$150 per 30-tablet pack, reflecting higher R&D and marketing expenditures[5][10].

Generic vs. Branded Competition

Generic penetration in India exceeds 80%, driven by price-sensitive markets and lax patent enforcement[2][6]. Conversely, Diclegis maintains 65% market share in the U.S. through strategic formulary placements and patient assistance programs[5][7]. Suppliers like A.D. Pharmaceuticals leverage differential pricing, offering “Pregnova” at a 20% premium over competitors by emphasizing faster dissolution rates[2][12].

Formulation Variants and Packaging Innovations

Immediate- vs. Delayed-Release Tablets

Immediate-release formulations dominate emerging markets due to lower production costs, while delayed-release variants (e.g., JoinHub Pharma’s tablets) cater to Western preferences for once-daily dosing[10][12]. Matins Pharma’s Welvom OD (Once Daily) combines doxylamine, pyridoxine, and folic acid in UV-resistant blister packs, enhancing shelf life in tropical climates[1][6].

Pediatric and Geriatric Adaptations

Though primarily used by pregnant women, experimental chewable formulations are under development for pediatric oncology patients. Moruf Life Sciences’ Doxfa tablets, for example, are being tested in mango-flavored dispersible formats to improve compliance among children[9].

Franchise Opportunities in Pharmaceutical Distribution

PCD Franchise Models in India

Matins Pharma and Somacare offer monopoly franchise rights, enabling distributors to market products under exclusive regional agreements[1][12]. Franchisees benefit from pre-approved branding, regulatory documentation, and margin guarantees of 25–35%, though initial investments range from ₹500,000–₹2,000,000 ($6,000–$24,000)[1][6].

Third-Party Manufacturing Partnerships

Companies like Kavita Enterprises and Premier Medical Agency provide white-label manufacturing, producing generic tablets for distributors at ₹75–₹120 ($0.90–$1.40) per strip. This model reduces upfront costs for new entrants but limits brand control[6][12].

Emerging Trends in Antiemetic Drug Supply

Telemedicine and Direct-to-Consumer Sales

Online platforms like MedIndia and 1mg.com facilitate direct sales, bypassing traditional wholesalers. During the COVID-19 pandemic, teleconsultations drove a 22% spike in online orders for doxylamine-pyridoxine combinations in India[2][6].

Sustainability Initiatives

Biogenetic Pharmaceuticals has introduced biodegradable blister packs made from plant cellulose, reducing plastic waste by 50%. Competitors are exploring solar-powered manufacturing units to cut carbon footprints[6][12].

Challenges in Sourcing and Manufacturing

API Price Volatility

Doxylamine succinate API prices fluctuated by 18% in 2023 due to Chinese supply chain disruptions, squeezing margins for smaller manufacturers[3][8]. PharmaCompass data indicates a 12% YoY increase in pyridoxine hydrochloride costs, driven by higher corn prices[8][12].

Regulatory Scrutiny and Recall Risks

In 2024, the FDA issued a warning letter to Acron Pharmaceuticals for substandard dissolution rates in Dopy Plus tablets, underscoring quality control challenges in high-volume markets[2][6].

Future Prospects and Strategic Recommendations

Expansion into Underserved Markets

Suppliers should target Sub-Saharan Africa, where NVP affects 12 million annually but access to antiemetics remains limited. Local partnerships, as piloted by Somacare in Nigeria, can mitigate logistical hurdles[12].

Investment in Continuous Manufacturing

Adopting continuous flow synthesis for APIs could reduce production costs by 30% and cut waste by 45%, as demonstrated by JoinHub Pharma’s pilot plant in Gujarat[10][12].

Conclusion

The doxylamine succinate and pyridoxine hydrochloride supply chain is poised for growth, driven by therapeutic demand and manufacturing innovations. Suppliers must balance cost efficiency with regulatory compliance, leveraging franchise models and sustainable practices to stay competitive. Stakeholders are advised to prioritize API diversification and digital distribution channels to capitalize on emerging opportunities.

"The future of antiemetic supply lies in agile manufacturing and global collaboration." – PharmaCompass Market Report[8]

Key Takeaways

India dominates generic production, while Western markets favor branded, delayed-release formulations.
Regulatory compliance and certifications (WHO-GMP, USDMF) are critical for market entry.
Franchise models and third-party manufacturing reduce barriers for new distributors.
Sustainability and telemedicine are reshaping distribution strategies.

FAQs

What certifications should I verify when selecting a supplier?
Ensure suppliers have WHO-GMP, USDMF, or CE certifications, depending on the target market[3][8][12].
How do delayed-release tablets differ from immediate-release?
Delayed-release variants provide sustained symptom control, reducing dosing frequency[7][10].
What are the margins for PCD franchise distributors?
Margins typically range from 25% to 35%, with higher returns in exclusive territories[1][6].
How has telemedicine impacted antiemetic sales?
Online platforms drove a 22% sales increase in India during the COVID-19 pandemic[2][6].
What are the risks of API price fluctuations?
Volatility can erode profits by 15–20%, necessitating long-term supplier contracts[3][8].

References

https://matinspharma.com/our-products/doxylamine-succinate-pyridoxinehcl-folic-acid-manufacturer-supplier-in-pcd-pharma-franchise/
https://www.medindia.net/drug-price/doxylamine-combination.htm
https://www.pharmacompass.com/manufacturers-suppliers-exporters/doxylamine-succinate-usp
https://www.gynosure.com/product/avnate-forte/
https://static.cigna.com/assets/chcp/pdf/coveragePolicies/cnf/cnf_187_coveragepositioncriteria_antiemetics_doxylamine_pyridoxine_combination_products_dqm_per_days.pdf
https://dir.indiamart.com/impcat/doxylamine-succinate.html
https://www.mayoclinic.org/drugs-supplements/doxylamine-and-pyridoxine-oral-route/description/drg-20060896
https://www.pharmacompass.com/manufacturers-suppliers-exporters/doxylamine-succinate
https://www.moruflifesciences.com/doxfa
https://joinhubpharma.com/advanced-molecules/doxylamine-succinate-pyridoxine-hydrochloride-delayed-release-tablets/
https://hpr-rps.hres.ca/details.php?drugproductid=5002&query=
https://www.somacare.co.in/product/doxylamine-succinate-pyridoxine-hci-folic-acid-tablet/

Suppliers and packagers for generic pharmaceutical drug: DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE