Manufacturing of Active Pharma Ingredients (API) (Amoxicillin Trihydrate, Azithromycin & Paracetamol). Investment Opportunity for Startups and Entrepreneurs.
Active pharmaceutical ingredients are the active substances that are utilized in the manufacture of a drug and have a pharmacological impact. They provide health advantages and play an important role in disease diagnosis, prevention, and treatment. Active pharmaceutical ingredients is also synthesized either with chemicals or through biotechnological methods.
The Active Pharmaceutical Ingredient (API) is that the part of any drug that produces the intended effects. Some drugs, similar to combination therapies, have multiple active ingredients to treat different symptoms or act in different ways that.
Amoxicillin is recommended by the world Health Organization for the treatment of infants with signs and symptoms of respiratory illness in resource-limited situations once the parents are unable or unwilling to accept hospitalization of the kid. Amoxicillin in combination with gentamicin is recommended for the treatment of infants with signs of alternative severe infections once hospitalization isn’t a choice.
Azithromycin is used to treat bound bacterial infections, equivalent to bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.
Azithromycin alone and in combination with alternative medications is currently being studied for the treatment of coronavirus disease 2019 (COVID-19). Currently, azithromycin has been used with hydroxychloroquine to treat certain patients with COVID-19. However, there are mixed reports of effectiveness once azithromycin was used at the side of alternative medications to treat other viral respiratory infections. Azithromycin also has been used to treat bacterial infections in hospitalized patients with COVID-19. a lot of information is needed before any conclusions is created relating to the possible advantages and risks of using azithromycin either alone or in combination with hydroxychloroquine in patients with COVID-19.
Amoxicillin Trihydrate may be a hydrate that’s the Trihydrate sort of amoxicillin; a semisynthetic antibiotic, used either alone or in combination with potassium clavulanate (under the trade name Augmentin) for treatment of a variety of bacterial infections. It’s a task as an antibacterial drug and an antimicrobial agent. It contains an amoxicillin.
The manufacturing process of Paracetamol is summarized in the following steps:
-charge acetic acid to the reactor.
-add p-nitro phenol as a starting material and iron powder as catalyst.
-Heat to temp 80-90 ºC.
-The reaction is exothermic and temp will rise to 130 ºC.
-After slight cooling
-Reflux the reaction at 118ºC for 3-4 hours.
-Cool to 60 ºC.
-Add methanol to the reaction.
-Reflux for 1 hour.
-distill the methanol and recycle.
-Add water to the obtained cake.
-And make a solution
-Add activated carbon.
-Dry the cake.
-Pulverize the dry cake to get the Paracetamol fine powder.
Other Therapeutic Applications
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Active Pharmaceutical Ingredient Market is valued at USD 172.69 Billion in 2018 and expected to reach USD 263.80 Billion by 2025 with the CAGR of 6.24% over the forecast period. The increasing incidence of chronic diseases, growing importance of generics, and the increasing uptake of biopharmaceuticals are some of the major factors driving the growth of the global APIs market. On the other hand, the unfavorable drug price control policies across various countries and the increasing penetration of counterfeit drugs are expected to restrain the growth of this market in the coming years.
Based on variety of manufacturer, the APIs market will be divided into captive API manufacturers and merchant API manufacturers. In 2019, the captive API manufacturers segment is expected to account for the biggest share of the APIs market. This will be attributed to the very fact that almost all huge pharmaceutical companies possess their API manufacturing facilities and are vertically integrated across the pharmaceutical supply chain. Moreover, innovator companies prefer in-house manufacturing of innovative products to avail economic benefit and prevent technology leakage.
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Increased investment in R&D by pharmaceutical companies for developing life drugs, adoption of biological therapies in wellness management, increasing outsourcing, increasing biologics approvals within the past year, increasing chronic and autoimmune diseases, increasing variety of branded medicine going off-patent creating a scope for biosimilars, demand of novel biologics therapeutics for rare diseases, increasing demand for antibody conjugates are few factors driving the biotech API market. Biotech API is additional segmented into monoclonal antibodies, recombinant proteins, vaccines and others (stem cell medical care and gene therapy).
Role of Government towards API
The government further approved production linked incentive (PLI) scheme for promotion of domestic manufacturing of critical KSMs/drug intermediates and APIs in the country with financial implications of Rs. 6,940 crore for next eight years.
Financial incentive will be given to eligible manufacturers of identified 53 critical bulk drugs on their incremental sales over the base year (2019-20) for a period of 6 years.
Out of 53 identified bulk drugs, 26 are fermentation based bulk drugs and 27 are chemical synthesis based bulk drugs.
Rate of incentive will be 20 per cent (of incremental sales value) for fermentation based bulk drugs and 10 per cent for chemical synthesis based bulk drugs.
The PLI scheme will lead to expected incremental sales of Rs. 46,400 crore and significant additional employment generation over eight years.
The drug industry has welcomed the incentives offered by the government to promote API units in India.
Besides APIs, the Cabinet also approved the scheme for promotion of medical device parks in the country in partnership with the states. A maximum grant-in-aid of Rs. 100 crore per park will be provided to the states. It will have financial implications of Rs. 400 crore.
The PLI scheme for promoting domestic manufacturing of medical devices will have financial implications of Rs. 3,420 crore for next five years.
Medical device is a growing sector and its potential for growth is the highest among all sectors in the healthcare market. It is valued at Rs. 50,026 crore for 2018-19 and is expected to reach to Rs. 86,840 crore by 2021-22. India depends on imports up to an extent of 85 per cent of total domestic demand of medical devices.
The coronavirus outbreak disrupting supply of active pharmaceutical ingredients (APIs) and medical devices from China to India, the government has come out with four schemes worth Rs 13,760 crore to encourage manufacturing of bulk drugs and medical devices in the country and their exports.
On March 21, the Union Cabinet under the chairmanship of Prime Minister Narendra Modi had approved an expenditure of Rs. 9,940 crore and Rs. 3,820 crore for APIs and medical devices, respectively.
The Cabinet also approved a scheme on promotion of bulk drug parks for financing common infrastructure facilities in three bulk drug parks with financial implication of Rs. 3,000 crore for next five years. The government will give grants-in-aid to states with a maximum limit of Rs. 1,000 crore per bulk Drug Park. Parks will have common facilities such as solvent recovery plant, distillation plant, power and steam units, common effluent treatment plant etc.
Union Cabinet scheme on Promotion of Bulk Drug Parks
- The scheme on Promotion of Bulk Drug Parks for financing Common Infrastructure Facilities in 3 Bulk Drug Parks with financial implication of Rs. 3,000 crore for next five years.
- Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical KSMs/Drug Intermediates and APIs in the country with financial implications of Rs6,940 crore for next eight years.
Promotion of Bulk Drug Parks
- Decision is to develop 3 mega Bulk Drug parks in India in partnership with States.
- Government of India will give Grants-in-Aid to States with a maximum limit of Rs. 1000 Crore per Bulk Drug Park.
- Parks will have common facilities such as solvent recovery plant, distillation plant, power & steam units, common effluent treatment plant etc.
- A sum of Rs. 3,000 crore has been approved for this scheme for next 5 years.
Production Linked Incentive Scheme
- Financial incentive will be given to eligible manufacturers of identified 53 critical bulk drugs on their incremental sales over the base year (2019-20) for a period of 6 years.
- Out of 53 identified bulk drugs, 26 are fermentation based bulk drugs and 27 are chemical synthesis based bulk drugs.
- Rate of incentive will be 20 % (of incremental sales value) for fermentation based bulk drugs and 10% for chemical synthesis based bulk drugs.
- A sum of Rs. 6,940 crore has been approved for next 8 years.
Active Pharmaceutical Ingredients Market Dynamics
The growing cases of chronic diseases are one of the leading causes of hospitalization, and a majority of the patients with these conditions may need re-admission in hospitals due to infection leading to other chronic diseases. For instance, according to the report published by the Centers for Disease Control and Prevention (CDC), nearly 92.1 million adults in the US dealt with at least one type of cardiovascular disease in 2017. Besides, CDC has also stated that out of the total annual healthcare expenditure, i.e., USD 27 trillion, 86% is for the people with chronic health conditions in the US.
The global increase within the patient pool having chronic ailments and rising infectious diseases round the world has created huge long-term demand of the small molecule active pharmaceutical ingredients (API) in the specialty active pharmaceutical ingredients (API) global market. Plus, growing demand for generic medicine is also expected to realize traction within the long-term market opportunities.
The emergence of COVID-19 has brought the world to a standstill. We have a tendency to perceive that this health crisis has brought an unprecedented impact on businesses across industries. However, this too shall pass. Rising support from governments and several companies will help within the fight against this highly contagious disease. There are some industries that are struggling and a few are thriving. Overall, almost every sector is anticipated to be wedged by the pandemic.
The increasing occurrences of chronic diseases, growth in abbreviated new drug applications (ANDA), rising acceptance and uptake of biopharmaceuticals, and the growing importance of generics across the globe is expected to boost the Active Pharmaceutical Ingredients Market growth. However, the rigorous regulatory policies and adverse drug control policies across various countries are likely to curb the growth of the market.
Pfizer, Inc. (US), Novartis AG (Switzerland), Sanofi (France), Boehringer Ingelheim (Germany), Bristol-Myers Squibb (US), Teva Pharmaceutical Industries Ltd. (Israel), Eli Lilly and Company (US), GlaxoSmithKline plc (UK), Merck & Co., Inc. (US), AbbVie Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), and AstraZeneca plc (UK).
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