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diphenhydramine hydrochloride + codeine phosphate + sodium citrate

Syrup 13.5 mg + 11.95 mg + 54.4 mg - 100 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #20110
This pharmaceutical contract manufacturer specializes in a wide range of dosage forms including tablets, capsules, injections, syrups, suspensions, and eye/ear drops. They operate across numerous key regions globally, with a strong presence in Africa, Asia Pacific, North America, and the EU. Their expertise spans several therapy areas such as generics, rare diseases, nutraceuticals, and functional ingredients. The company boasts several patented products and holds GMP certifications, ensuring high-quality manufacturing standards. They are known for their commitment to research and development, constantly innovating with new ingredients like Fibronectin for wound healing.

Manufacturer usually replies in 8 days

diphenhydramine hydrochloride

Oral solution 12.5 mg/5 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #13225

It is an Indian manufacturer that is active in 40+ countries. They are in this line of business for 85+ years. The company has a more than $150 million turnover. The company manufactures and distributes more than 100 APIs and 200 formulations which is responsible for 25000+ SKUs. Quality control and quality assurance are one of the focus areas for the company.

Manufacturer usually replies in 16 days

diphenhydramine hydrochloride + ibuprofen

Capsules 200 mg + 25 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #31580

Established in 1990, this Indian manufacturer employs approximately 3,065 individuals and specializes in developing and manufacturing IP-led niche finished dosage formulations. As a CTD dossier owner and manufacturer, it holds GMP certifications from major regulatory authorities, including the US FDA, EU-GMP, Health Canada, and UK MHRA, ensuring compliance with stringent international quality standards. The company operates eight manufacturing units across India, Singapore, Italy, the United States, and Kenya, producing a range of products, including soft gelatin capsules, tablets, and ointments. As a CTD dossier owner and manufacturer, its products are distributed in over 100 countries worldwide.

Manufacturer usually replies in 30 days

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Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride as the name suggests is the hydrochloride salt form of diphenhydramine. It is a first-generation histamine antagonist and an ethanolamine with anti- allergic activity. Diphenhydramine Hydrochloride relieves symptoms of red, irritated, itchy, watery eyes, sneezing, runny nose caused by hay fever, allergies, or the common cold and cough caused by airway irritation. It has antiemetic, antitussive, hypnotic, and antiparkinson properties. When used to cure allergies, its receptors exist both peripherally and in the CNS and can sedate as an antagonist of histamine H1 receptors in the CNS. Due to its sedative effect, it is not the first choice of medicine for curing allergies. However, it has been used in many non-prescription OTC sleep medicines and cough-and-cold medications sold for nighttime use. Diphenhydramine Hydrochloride is sold under the brand names like Allerdryl, Benadryl, Benhydramin and Benylin to name a few. George Rieveschl, a former professor at the University of Cincinnati discovered it in 1943. It has the distinction of being the first prescription antihistamine approved by the U.S. FDA In 1946. Further research in the 1960s revealed that its effective in inhibiting the reuptake of neurotransmitter serotonin.

Dosage and administration

Diphenhydramine Hydrochloride is sold as tablets and capsules. The recommended dose for adults and children older than 12 years is 25 mg to 50 mg or 1 to 2 capsules. The pediatric dose for children aged 6 to 12 years, is 12.5 mg. and parents should consult for dose in kids younger than 6 years.

The cost of Diphenhydramine Hydrochloride

In the USA, the consumers pay an average retail price of $5 for a generic 30 capsules of 25mg. However, this medicine is significantly cheaper in the developing world. In India, for 20 capsules, the consumers pay an average retail price of USD0.40 or 40 cents.

How does Diphenhydramine Hydrochloride Work?

Diphenhydramine hydrochloride competitively blocks H1receptors. This results in the prevention of histamine actions on bronchial smooth muscle, capillaries, and gastrointestinal smooth muscle. This achieves the desired reduction in histamine-induced bronchoconstriction, vasodilation, increased capillary permeability, and GI smooth muscle spasms. Diphenhydramine hydrochloride has antitussive, hypnotic, antiemetic, and antiparkinson actions. In its actions in curing allergies, its receptors exist both peripherally and in the CNS and can sedate as an antagonist of histamine H1 receptors in the CNS. Due to its sedative effect, it is not the first choice of medicine for curing allergies.

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