Paracetamol API manufacturers in China

Introduction

Paracetamol, otherwise also known as acetaminophen or more commonly known as PCM  is used to treat fever and mild to moderate aches. Paracetamol is a low-cost medication and is widely available around the world. Its uses include over-the-counter distribution, primary care prescription therapy, secondary care 'post-operative' application, and emergency treatment. (1,2) This medication may take up to an hour to show its effect. Conventionally, the maximum daily adult dose of paracetamol or acetaminophen is 4 g, with a recommended dosage of 352-650 mg every 4-6 hours or 1 g every 6 hours. However, in 2012, the FDA suggested, although did not mandate that the maximum daily dose of paracetamol or acetaminophen for adults is 3 g, with no more than 650 mg every 6 hours. At recommended doses, this medication is safe to be taken during pregnancy and breastfeeding. (1,3,4)

Paracetamol is available as a generic medication. Some well-known paracetamol brands are Tylenol, Panadol, Tempra, Ofirmev, Disprol, Hedex, Actamin, feverall, and Medinol. (1,5,6)

Paracetamol vs ibuprofen

Paracetamol and ibuprofen are both painkillers. While paracetamol belongs to a class of drugs known as analgesics, ibuprofen belongs to a class of drugs commonly known as NSAIDs, i.e., non-steroidal anti-inflammatory drugs. It is therefore also why the mechanism of action of both drugs are different. They both help relieve the symptoms of pain; however, ibuprofen additionally helps decrease inflammation. 

Paracetamol can be taken empty stomach or with food, and ibuprofen is recommended to be always taken with food or a glass of milk to avoid chances of an upset stomach. While both the drugs are safe, paracetamol has fewer risks associated with it, especially with various population groups, such as the elderly, pregnant women, those at risk of GI bleeding, or those with kidney diseases. (7,8)

Chemical features

Paracetamol or acetaminophen is a p-aminophenol derivative. (9)

• CAS number: 103-90-2

• Molecular structure: 

• Molecular formula: C8H9NO2 or HOC6H4NHCOCH3

• Chemical Name: N-acetyl-para-aminophenol (APAP)

• Weight: 151.16 g/mol

• Appearance: Large monoclinic prisms from water

• Other physical features: 

• ­ Odorless

• ­ Slightly bitter taste

• ­ Very slightly soluble in cold water but greater solubility in hot water

• ­ Freely soluble in alcohol; soluble in methanol, ethanol, dimethylformamide, ethylene dichloride, acetone, ethyl acetate; slightly soluble in ether

• ­ Practically insoluble in petroleum ether, pentane, benzene

Paracetamol forms and specifications

Paracetamol is widely available in tablet and capsule formulations. For people who find it difficult to swallow tablets or capsules, the medication is also available as a syrup or as soluble tablets which can be dissolved in water for drinking. Paracetamol is also available in suppository form or as an injection to be given in the vein, usually in the hospital. (1,10,11) 

• Paracetamol API powder is a white crystalline powder used for manufacturing paracetamol medication in various formulations, either alone or in combination with other drugs.

• Paracetamol tablets (500 mg) is the most commonly used formulation of paracetamol with a strength of 500 mg of paracetamol per tablet. They are meant for oral administration. 

• Paracetamol capsules also come in the strength of 500 mg of paracetamol per capsule. The capsules are blue and white in color, containing a white paracetamol powder. The capsules are also meant for oral administration, to be swallowed with water.

Mechanism of action

The exact mechanism through which paracetamol exerts its effect is not yet fully determined. Paracetamol may inhibit the nitric oxide (NO) pathway mediated by a variety of neurotransmitter receptors including N-methyl-D-aspartate (NMDA) and substance P. Thus, resulting in elevation of the pain threshold. The antipyretic activity of paracetamol may result from the inhibition of prostaglandin synthesis and release in the CNS, and prostaglandin-mediated effects in the anterior hypothalamus on the heat-regulating center. (9)

Paracetamol manufacturing process

The starting material for commercially manufacturing paracetamol is phenol. Phenol is nitrated to give a mixture of the ortho and para-nitrotoluene. The o-isomer is then removed by steam distillation, and the p-nitro group is reduced to a p-amino group. This is further acetylated to give paracetamol. (12)

Uses of paracetamol

Paracetamol is intended to be used for treating mild to moderate pain, ranging from headaches, menstrual periods, backaches, toothaches, osteoarthritis, or pain associated with cold and flu. It is also used to reduce fever. (13)

Most people, including pregnant and breastfeeding women, can take paracetamol safely. However, some people must take precautions when taking paracetamol. They need to consult a doctor or pharmacist especially, if: (1)

• They are taking any medication for epilepsy

• They are taking any medication for tuberculosis (TB)

• They have experienced an allergic reaction to paracetamol in past or experienced allergic reactions with any other medication in the past

• They regularly drink more than the maximum recommended amount of alcohol that is 14 units a week

• They have any liver or kidney related problems

• They take blood-thinner medications such as warfarin and need to take paracetamol too, regularly 

Paracetamol dosage

Paracetamol or acetaminophen is an active ingredient in many OTC and prescription medicines. It is also combined with other APIs to treat allergy, cough, colds, flu, and sleeplessness. Acetaminophen can cause serious liver damage if used in quantities more than directed and the US FDA has issued guidance on its dosage to improve the safety of the consumers when using acetaminophen. (4)

Overdose of paracetamol occurs when a person has taken more than the recommended maximum daily dose of paracetamol. This recommended maximum daily dose of paracetamol for healthy adults is three or four grams in a day, beyond which, taking this medication can cause potentially fatal liver damage. As per the latest FDA directions, the maximum daily dose of paracetamol or acetaminophen for adults is 3 g, with no more than 650 mg every 6 hours. (3,4)

Side effects of paracetamol

Side effects from taking paracetamol are rare but can include: (10)

• Allergic reaction, such as a rash or swelling

• Low blood pressure, flushing, fast heartbeat, often observed when paracetamol is given in a hospital setting directly into a vein in your arm

• Thrombocytopenia or leukopenia

• Liver and kidney damage due to an overdose can be fatal in severe cases 

Paracetamol API manufacturers in China

Various manufacturers around the globe follow cGMP guidelines for producing paracetamol. Leading active pharmaceutical ingredients manufacturers from China are: (14,15,16)

• Anqiu Lu'an Pharmaceutical Co., Ltd.: Anqiu Lu'an Pharmaceutical Co., Ltd. is the largest Asian bulk pharmaceutical enterprises that specialize in producing and exporting paracetamol (acetaminophen) with an annual capacity of 40,000 tons; paracetamol DC (DC90, DC96, DC85, DC83, DC77, etc.) at an annual capacity of 7,000 tons and paracetamol DC by spray drying with an annual capacity of 5,000 tons). They also contract manufacture paracetamol finish dosage with an annual capacity of 8 billion tablets. Their staff and systems comply with cGMP guidelines. Almost 80% of their products are exported worldwide.

• Anhui BBCA Pharmaceutical Co., Ltd.: AnHui BBCA Pharmaceutical Co., Ltd. is the mainstay subsidiary of BBCA Group which was found in the 1960s. It is the second-largest manufacturer of paracetamol (acetaminophen) in China. The company constitutes of three systems - pharmaceutical R&D, production, and sale. It has 5 pharmaceutical plants and 45 GMP certified production lines, mainly involving R&D, production, and sale of biological pharmacy, chemical pharmacy, and traditional Chinese medicine. They manufacture products across nine classes of drugs including antipyretic-analgesics, cardiovascular, antibiotics, nervous system drugs, anti-tumor drugs, anti-ulcer drugs, hormonal drugs, and nutraceuticals among others.

You can also find details around more suppliers for paracetamol API in bulk at PharmaSources.com. PharmaSources.com is one of the leading and trustworthy vertical e-commerce online pharmaceutical marketplaces. It provides information on quality pharmaceutical products and suppliers for its customers and delivers services to 90,000+ active members. The services are provided globally, across 211 countries and regions. PharmaSources.com sells over 1,600,000 products in 30 major pharmaceutical categories across the supply chain.

Sources:

1. https://www.nhs.uk/medicines/paracetamol-for-adults/

2. https://pubmed.ncbi.nlm.nih.gov/19058473/

3. https://www.medscape.com/answers/820200-27207/what-are-the-recommended-maximum-daily-dosages-of-acetaminophen-in-adults-and-children

4. https://www.fda.gov/drugs/information-drug-class/acetaminophen-information

5. Tarascon Pocket Pharmacopoeia, 2013 edition, page 12

6. https://medlineplus.gov/druginfo/meds/a681004.html

7. https://www.healthline.com/health/pain-relief/ibuprofen-vs-acetaminophen

8. https://www.nib.com.au/the-checkup/healthy-living/ibuprofen-vs-paracetamol-difference

9. https://pubchem.ncbi.nlm.nih.gov/compound/Acetaminophen#section=Mechanism-of-Action

10. https://www.nhsinform.scot/tests-and-treatments/medicines-and-medical-aids/types-of-medicine/paracetamol

11. https://www.medicines.org.uk/emc/product/4195/pil#gref

12. https://www.ch.ic.ac.uk/vchemlib/mim/bristol/paracetamol/paracet.htm

13. https://www.webmd.com/drugs/2/drug-57595/paracetamol-oral/details

14. http://www.luanpharm.com/english/about.asp

15. http://en.bbcayy.com/

16. www.Pharmasources.com