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Hyoscine butylbromide manufacturers

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Country of origin : Malaysia

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hyoscine butylbromide

Tablets 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Malaysia
GMP approvals
EU GMP
Manufacturer #20853
The company’s mission is to invest in and operate businesses that restore health and enhances the lives of those they serve. Healthcare professionals use medicines and diagnostic devices to treat and manage infections, cardiovascular, metabolic, gastroenterological, rheumatic conditions, and more.

hyoscine butylbromide

Tablets 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Malaysia
GMP approvals
EU GMP, PICS
Manufacturer #20652

Established in 1967, this Manufacturer is a CTD dossier owner and manufacturer with a global presence spanning over 21 countries and regions. With a dedicated team of over 500 employees, it operates four GMP-certified facilities in Melaka, Malaysia, producing a diverse range of products including tablets, capsules, powders for oral suspensions, liquids, creams, ointments, and sterile eye drops. As a GMP manufacturer, it holds certifications such as EU GMP, PIC/S GMP, TGA GMP, ISO 13485, ISO 9001, ISO 17025, and Halal, ensuring adherence to international quality standards. The Manufacturer's commitment to excellence as a CTD dossier owner and manufacturer and GMP manufacturer solidifies its reputation in the global pharmaceutical market.​

 

hyoscine butylbromide

Tablets 10mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Malaysia
Manufacturer #1447
The company was established in the early 1990s. It is one of the largest integrated pharmaceutical groups with a firm focus on protecting the nation via providing accessible and affordable healthcare solutions, with operations in Malaysia and Indonesia. It is involved in various segments of the pharmaceutical value chain, including research and development, manufacturing of generic drugs and medical devices, logistics and distribution, sales and marketing, as well as a community pharmacy.

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Hyoscine butylbromide

Hyoscine butylbromide, also called scopolamine butylbromide is a medication used in the treatment of Crampy abdominal pain, bladder & esophageal spasms & renal colic. It especially eases the bloating and the spasm-type pain associated with irritable bowel syndrome and diverticular disease. Its actions relax muscles in gastrointestinal and urinary systems. Hyoscine butylbromide also improves respiratory secretions at the end of life. It is also effective in decreasing the duration of the first stage of labor, while not being associated with any obvious adverse outcomes in mother or newborn. HB improves the quality of pictures during abdominal or pelvic MRI or CT. It can also help bladder cramps and period pain. Its medicine form is manufactured from Hyoscine, which occurs naturally in the plant deadly nightshade. Hyoscine butylbromide is sold under the brand name Buscopan among others. Hyoscine butylbromide has not received approved for sales in the United States, but a similar compound, Methscopolamine is used instead. In Europe, the Manufacturer and Licence Holder is Istituto De Angeli S.r.I, Loc. Prulli in Italy and procured from within the EU. The Licence Holder is LTT Pharma Limited from the UK. Forms and Dosage Hyoscine butylbromide is taken orally or given as an injection into a muscle, or into a vein, as a 20 mg in 1 ml ampoule for Intra Muscular or slow Intra Venous injection. In the treatment of MR enterography, the standard prescribed dose is 0.3 mg/kg IV with a maximum dose capped at 20 mg. in the treatment of Acute spasms, the oral medicine for children in the age group of 6-12 yrs old is 10 mg/dose and for 12-18 yrs old: 20 mg/dose. As an injection for either the muscle or nerves, the recommended dosage for children age 2-6 yrs old is 5 mg per dose with max capped at 15 mg per day. For children aged 6-12 years old it is 5-10 mg per dose with max capped at 30 mg per day and for teenagers, in the age group of 12-18 yrs old, the prescribed dose is 20 mg per dose, with max capped at 80 mg/day. For Adults, the standard recommended dose is 10-20 mg per dose up to 3-5 times a day with the maximum capped at 100 mg per day.

The cost of Hyoscine butylbromide

In the developing countries in India, a 2 weeks supply of tablet costs the consumer as low as USD2.3, whereas the injection cost USD1.5. in Australia, 5 ampoules of 20 mg injections cost AUD23.

How does Hyoscine butylbromide work?

Hyoscine butylbromide quaternary ammonium compound as well as a semisynthetic derivative of Scopolamine. As an Antimuscarinic, it binds to muscarinic acetylcholine receptors, blocking their effect. The attachment of the butyl-bromide moiety minimizes undesirable central nervous system side effects associated with scopolamine/Hyoscine, thereby effectively preventing the movement of this drug across the blood-brain barrier. It decreases the stimulation in smooth muscle contractions and the production of respiratory secretions.

Finding Hyoscine butylbromide Manufacturers and Suppliers:

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