API Production. Manufacturing of Active Pharma Ingredients (API)

Pharma Raw Material (APIBulk Drugs) Manufacturing

API Production. Manufacturing of Active Pharma Ingredients (API), Cephalexin, Ampicillin Trihydrate, Ibuprofen and Paracetamol.

API (Active Pharmaceutical Ingredient) means the active ingredient which is contained in medicine. For example, an active ingredient to relieve pain is included in a painkiller. This is called API. A small amount of the active ingredient has an effect, so only a tiny part of the active ingredient is contained in medicine.

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The API form that is used in a formulation is often the most thermodynamically stable crystalline form. As such, the phenomenon of hydrogen bonding in combination with there being many functional groups on the API usually results in the available crystalline form being a hydrate.

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Ampicillin is used to treat infections by many Gram-positive and Gram-negative bacteria. It was the first “broad spectrum” penicillin with activity against Gram-positive bacteria, including Streptococcus pneumonia, Streptococcus pyogenic, some isolates of Staphylococcus aureus (but not penicillin-resistant or methicillin-resistant strains), Trueperella, and some Enterococcus.

Paracetamol is used for the relief of mild to moderate pain. The use of the intravenous form for short-term pain in people in the emergency department is supported by limited evidence. In adults it appears to be useful for migraines, tension headaches, perineal pain after childbirth, and kidney stone pain.

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Ibuprofen is a medication in the nonsteroidal anti-inflammatory drug class that is used for treating pain, fever, and inflammation. This includes painful menstrual periods, migraines, and rheumatoid arthritis. It may also be used to close a patent ductus arteriosus in a premature baby.

Market Outlook

The production-linked incentive scheme – which accounts for INR0.9 billion of planned outlay – offers an incentive of up to 20% of sales for fermentation based products and up to 10% for chemical synthesis-based products for the next eight to nine years. This should help to bridge the price gap and make domestic production more competitive. The government has also allocated USD0.4 billion under the capex assistance scheme to fund up to 90% of the investment need to build common infrastructure facilities in three bulk drug parks. We believe this will aid the investment decisions of Indian pharma companies, particularly in the current environment where the focus in on conserving cash.

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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. Active pharmaceutical ingredients are an active ingredient of any drug or tablet, which possesses medicinal properties. Some drugs with combined therapy have many active ingredients to treat different disorders.

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

Higher Growth in the APAC Active Pharmaceutical Ingredients Market

Healthcare spending has witnessed continued growth for some time now. Even though the proportion of healthcare spending in the APAC region is comparatively low, the growth rate in this strategic region has outpaced that of mature markets in North America and Europe. Rising healthcare spending has led to quality healthcare becoming accessible along with a higher demand for pharmaceutical products across APAC. The pharmaceuticals consumed here are mostly produced in onshore manufacturing units. Furthermore, contract manufacturing organizations are key outsourcing allies for pharmaceutical companies that supply their wares to North America and Europe.

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Huge investment promises from different countries predict a bright future for India. It has a well-developed administration and an independent judicial system with an ever-growing consumer base. It has a huge pool of hard-working skilled workers in all fields. The government has set up tax and non-tax incentives to establish new industrial entities in specific sectors, which include energy, ports, highways, electronics, and software.

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The global active pharmaceutical ingredients market has been broadly segmented based on manufacturer, APIs, drug, therapeutic, and region. In terms of manufacturer, the global market has been classified into in-house API manufacturing and API contract manufacturing.

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.

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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.

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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.

Market Research Reports:- India Active Pharmaceutical Ingredient (API)

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.

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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.

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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 Projects:- Active Pharma Ingredients (api) (cephalexin, Ampicillin Trihydrate, Ibuprofen And Paracetamol)

 

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.

Related Projects: – Active Pharma Ingredients (API)

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.

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Key players

Alpha Remedies Ltd.

Ankur Drugs & Pharma Ltd.

Aurobindo Pharma Ltd.

Cian Healthcare Ltd

Cipla Ltd.

Dr. Reddy’S Laboratories Ltd.

Farmson Pharmaceutical Gujarat Pvt. Ltd.

Glaxosmithkline Pharmaceuticals Ltd.

Indoco Remedies Ltd.

Pan Drugs Ltd.

Piramal Enterprises Ltd.

Sanofi India Ltd.

Sri Krishna Pharmaceuticals Ltd.

Teva Pharmaceutical & Chemical Inds. India Pvt. Ltd.

Triton Laboratories Ltd.

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