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terbutaline + ambroxol hydrochloride + guaifenesin + menthol

Syrup 1.5 mg + 15 mg + 50 mg + 1 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #38728

Established in 2012, this Manufacturer is a CTD dossier owner and manufacturer and GMP manufacturer with products sold in over 39 countries across four continents. With multiple WHO-GMP and other regulatory approvals (e.g., Ghana FDA, Philippines FDA, Kenya PBB, Tanzania TFDA, Nigeria NAFDAC), it operates several finished dosage and R&D production lines (tablets, capsules, injectables, liquids, softgels, effervescent, suppositories). As a CTD dossier owner and manufacturer, it supports regulatory filings worldwide. Headquartered in India and employing a global workforce, it serves diverse markets as a CTD dossier owner and manufacturer and GMP manufacturer.

Manufacturer usually replies in 17 days

ambroxol hydrochloride + terbutaline + gabapentin

Syrup 15 mg + 1.250 mg + 50 mg / 5 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA, EU GMP, WHO
Manufacturer #18135
This pharmaceutical company is a global leader specializing in ophthalmic, ENT, and dermatological medications. Founded over four decades ago, they boast a portfolio of over 300 products sold in over 67 countries across regions like the EU, Africa, and Asia. Their key therapeutic areas include dry eyes, eye infections, respiratory tract infections, ear infections, eczema, psoriasis, and acne. They offer various dosage forms such as eye drops, ointments, gels, nasal sprays, creams, and oral medications. The company adheres to international GMP certifications and possesses state-of-the-art manufacturing facilities. Their expertise extends to the development of specialized pharmaceutical excipients, including Stabilized Oxychloro Complex (SOC).

Manufacturer usually replies in 26 days

terbutaline

Tablets 2.5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #38728

Established in 2012, this Manufacturer is a CTD dossier owner and manufacturer and GMP manufacturer with products sold in over 39 countries across four continents. With multiple WHO-GMP and other regulatory approvals (e.g., Ghana FDA, Philippines FDA, Kenya PBB, Tanzania TFDA, Nigeria NAFDAC), it operates several finished dosage and R&D production lines (tablets, capsules, injectables, liquids, softgels, effervescent, suppositories). As a CTD dossier owner and manufacturer, it supports regulatory filings worldwide. Headquartered in India and employing a global workforce, it serves diverse markets as a CTD dossier owner and manufacturer and GMP manufacturer.

Manufacturer usually replies in 17 days

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Terbutaline

Terbutaline is used to treat conditions with symptoms of wheezing and shortness of breath from lung conditions like Asthma, Chronic obstructive pulmonary disease, Bronchitis and Emphysema. As a bronchodilator, Terbutaline is a beta-agonist. It relaxes the muscles around the airways causing them to open up making it easy to breathe. It is a fast-acting bronchodilator, which often used for short-term asthma relief. It starts working within 15 minutes and can provide relief for up to 6 hours. Terbutaline is used to delay premature labour and is not approved by the FDA. It is a pregnancy medication routinely used to stop contractions. After uterine inversion, in the third stage of labour, terbutaline can be used to relax the uterus before replacing uterine. Terbutaline is sold under the brand name Bricanyl among others Aktiebolaget Braco of Sweden patented it in 1966 and it came into medical use in 1970.

Dosage Forms & Strengths

Terbutaline is sold as a Tablets of 2.5mg, 5mg strength, as an injectable solution in 1mg/mL. While treating a Bronchospasm, the usual Initial dose is set at 2.5 mg three to four times a day, while the Maintenance dose is 5 mg, taken three times daily every 6 hours while the patient is awake. In the delaying Preterm Labor (Off-label), the usual initial dose is 2.5-5 mcg per min administered through an IV, this slowly increased as it is tolerated, at 20-30 minute intervals.

The wholesale price of Terbutaline

In the USA, consumers have to pay an average retail price of $163 for a supply of 30, 2.5mg tablets. However the price of this medication significantly lower in the developing world. The price of this medicine for the same supply in India costs US$0.25.

How does Terbutaline work?

When used as tocolytic, it works by delaying preterm labour. It actions prevent and slow contractions of the uterus. Eventually resulting in the delay of birth for several hours or days. When used as a bronchodilator, it is a fast-acting bronchodilator which helps the muscles in the lungs to relax, opening the airways, thus making it easy to breathe.

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