Startup Opportunities in Active Pharma Ingredients (API) (Amoxicillin Trihydrate, Azithromycin & Paracetamol). Most Profitable Business Idea with Huge Demand.

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 in which.

Active Pharmaceutical Ingredient (API), is that the term accustomed refer to the biologically active component of a drug product (e.g. tablet, capsule). Drug product are usually composed of many components. The said API is that the primary ingredient. Alternative ingredients are usually known as excipients and these substances are always needed to be biologically safe, usually creating up a variable fraction of the drug product. The procedure for optimizing and compositing this mixture of components utilized in the drug is known as formulation.

Amoxicillin is susceptible to degradation by β-lactamase-producing bacteria, that are resistant to most β-lactam antibiotics, similar to penicillin. For this reason, it should be combined with clavulanic acid, a β-lactamase inhibitor. This drug combination is usually known as co-amoxiclav.

Azithromycin is used to treat sure bacterial infections, similar to bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.

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Azithromycin alone and in combination with alternative medications is currently being studied for the treatment of coronavirus wellness 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 along with 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 data is needed before any conclusions are often made regarding the possible benefits and risks of using azithromycin either alone or in combination with hydroxychloroquine in patients with COVID-19.

Amoxicillin Trihydrate could be a hydrate that's the Trihydrate form 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 role as an antibacterial drug and an antimicrobial agent. It contains an amoxicillin.

Manufacturing Process

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.

-Filter

-Dry the cake.

-Pulverize the dry cake to get the Paracetamol fine powder.

Applications:-

Communicable Diseases

Oncology

Diabetes

Cardiovascular Diseases

Pain Management

Respiratory Diseases

Other Therapeutic Applications

Market Outlook

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.

Increasing prevalence of congenital heart disease acts as a growth driver for the general market. Epidemiological studies have shown however lifestyle habits similar to smoking and dietary irregularities-which may end up in obesity-are associated with increased risk of wellness. Increasing prevalence of blubber is hence estimated to drive the demand for APIs. Genus Apis are used as antibody drug conjugates (ADCs). ADCs are important and effective treatment modalities utilized in combination with monoclonal antibodies and biologically active drugs for cancer. APIS target cancer cells effectively, whereas causing minimum exposure of medicine to healthy tissues.

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Development of next-generation antibodies similar to antibody-drug conjugates and rising venture capital investments and applications of organism antibodies are the factors booming monoclonal antibodies market growth. Based on the customer, biotech API is further divided into biologics and biosimilars. Biologics accounted for the most important share in 2018 and is expected to grow at a high single-digit. Biologics market is driven globally because of the adoption of biological therapies in disease management, increasing biologics approvals within the past year, increasing chronic and autoimmune illnesses and increasing elderly population globally.

Global Active Pharmaceutical Ingredient Market Dynamics

The key factor for growth of global Active Pharmaceutical Ingredient market is the rise of demand for the new drug discovery for treatment of various chronic and infectious diseases like HIV, cancer, arthritis, bone & joint infections, hepatitis-B, Aids etc. across the globe. According to WHO in 2018, the global cancer burden has risen to 18.1 million new cases including 9.6 million deaths across the globe. Due to such rise in the cases of cancer, the new drugs discovery using the Active Pharmaceutical Ingredient has become essential. Recently according to the American Chemical Society in 2019, there has been 48 new drugs has been approved by the FDA U.S. out of which 11 for new cancer treatments with the innovative molecular pharmaceutical ingredients. However, the Active Pharmaceutical Ingredient market is hampered by need for high investment with huge capital requirement for research and developments. Moreover rising health cautiousness among the people with technological advancement huge investment for launching of new drugs and biological products, acquisitions, collaborations, and regional expansion will provide huge opportunity for Active Pharmaceutical Ingredient market. For instance in 2019, Raquel has been acquired by Merck & Co. for roughly around USD 2.7 billion in cash, for making cancer drug using Active Pharmaceutical Ingredient with the latest small-molecule-focused.

Specialty active pharmaceutical ingredients (API) manufacturers will need to focus on cost management and product sale and distribution to target wider geography. Portfolio strengthening and development of specialty active pharmaceutical ingredients (API) for wider application such in the pediatric and geriatric patient base are the key strategies needed to be focused by the leading industry.

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The emergence of COVID-19 has brought the world to a standstill. We understand 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 can help in the fight against this highly contagious disease. There are some industries that are struggling and some are thriving. Overall, almost every sector is anticipated to be impacted by the pandemic.

We are taking continuous efforts to help your business sustain and grow during COVID-19 pandemics. Based on our experience and expertise, we will offer you an impact analysis of coronavirus outbreak across industries to help you prepare for the future.

Role of Government towards API

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.

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.

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.

Related Videos: - Active Pharma Ingredients (API) - Global Market Estimated to Reach US$ 21.9 billion by 2023

Investment Opportunities in API Bulk Drugs & Intermediates Manufacturing Unit

Production of Paracetamol (Acetaminophen), bulk pharmaceutical active ingredient

Investment Opportunities in APIs KSMs Drug Intermediates Bulk Drug Industries

Manufacturing Business Ideas in Pharmaceutical Industry

Details:

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.

Key Players

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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