Suppliers and packagers for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

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

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
Mylan Pharms Inc	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	207825	ANDA	Mylan Pharmaceuticals Inc.	0378-4615-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01)	2020-07-21

Suppliers for the Pharmaceutical Drugs: Doxylamine Succinate and Pyridoxine Hydrochloride

Last updated: July 31, 2025

Introduction

The pharmaceutical landscape features a diverse network of suppliers for active pharmaceutical ingredients (APIs), especially for well-established compounds like Doxylamine Succinate and Pyridoxine Hydrochloride. These compounds serve crucial roles in sleep aid formulations and vitamin B6 supplementation, respectively. Understanding the key suppliers, their global footprints, quality standards, and market influence is vital for pharmaceutical companies, generic drug manufacturers, and healthcare providers aiming to ensure supply chain robustness and regulatory compliance.

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Overview of Doxylamine Succinate and Pyridoxine Hydrochloride

Doxylamine Succinate is an antihistamine primarily used as a short-term sleep aid due to its sedative properties. It is also employed in combination therapies for nausea, especially during pregnancy. Its chemical structure features a succinate salt form, enhancing stability and bioavailability.

Pyridoxine Hydrochloride is the hydrochloride salt form of vitamin B6, essential for amino acid metabolism, neurotransmitter synthesis, and hemoglobin production. It is a widely used vitamin supplement and is integrated into multiple multivitamin formulations.

Both APIs fulfill high-demand segments in pharmaceuticals and OTC markets, necessitating a reliable and compliant supply chain.

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Leading Global Suppliers for Doxylamine Succinate

1. Hubei Meihua Biological Technology Co., Ltd.
   Based in China, Meihua is a prominent manufacturer of pharmaceutical ingredients, including Doxylamine Succinate. The company adheres to Good Manufacturing Practices (GMP) and holds relevant certifications from regulatory bodies such as the NMPA (National Medical Products Administration) and GMP accreditation from Europe and the US.

2. Jiangxi Phalanx Biologicals Co., Ltd.
   Also China-based, Phalanx supplies Doxylamine Succinate APIs globally, emphasizing quality control and consistency. Their facilities comply with international standards, making them a preferred vendor for large-scale pharmaceutical firms.

3. Kaké Pharma Inc.
   Located in India, Kaké Pharma offers Doxylamine Succinate API with ISO 9001 and WHO-GMP certification, catering mainly to North American and European markets.

4. Taiwan MVP Pharmaceutical Corporation
   Recognized for high-quality APIs, MVP Pharmaceutical supplies Doxylamine Succinate with strict quality assurance processes, serving clients in North America, Europe, and Asia.

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**Leading Global