An Update On the Generic Drug Approval Process

Hamrell, Michael R.

doi:10.3109/10601339709019635

Cited by 5 publications

(5 citation statements)

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“…The formula that passes the trial batch and scale up trial and passes to comply at least 3-month stability according to the ICH guideline can be called a lead formula. But it can be or need to change depending upon the situation arise as explained already [14].…”

Section: Lead Formula Identificationmentioning

confidence: 99%

“…These lawsuits can be costly and timeconsuming and can delay the availability of generic drugs. [23] Current Scenario of Generic Drugs: The current scenario of generic drugs is one of growth and opportunity, as the demand for affordable medications continues to increase. Generic drugs play an important role in providing patients with access to safe and effective treatments at a lower cost than their brand-name counterparts.…”

Section: Lead Formula Identificationmentioning

confidence: 99%

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Generic Drug Development and Current Scenario

2023

IJFMR

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Drugs or medicines are those which are used for treatment, diagnosis, mitigation and prevention of diseases. But it’s very expensive. Not or all but for lower- and middle-class people taking treatment is very difficult because of the cost of the medicines. Many deaths are caused because the patient cannot afford the cost of the medicines. The entry of generic medicines in market brought a revolutionary change in healthcare system and the market share is continuously increasing. In the present scenario generic drugs have an important role in pharmaceutical market. Generic drugs are bioequivalent to brand drugs and are much cheaper as compared to brand drugs because of no R&D cost and minimum marketing expenses.This review presents considerations which can be employed during the development of a semisolid topical generic product. This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial production.

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Section: Lead Formula Identificationmentioning

confidence: 99%

Section: Lead Formula Identificationmentioning

confidence: 99%

Generic Drug Development and Current Scenario

2023

IJFMR

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“…At the state level, state drug regulatory authority issues licences to manufacture approved drugs and to monitor the quality of drugs along with CDSCO. [2][3][4]…”

Section: Regulatory Environmentmentioning

confidence: 99%

EVALUATION OF PHARMACEUTICAL REGULATORY SYSTEM & PRESENT SCENARIO OF INDIAN PHARMACEUTICAL INDUSTRY

Mary¹

2017

WJPR

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Indian pharmaceutical industry evolved in true sense only after independence. India is the fourth largest generic pharmaceutical market in the world. Ranking fourth in terms of volume and thirteenth in terms of value in global pharmaceutical markets and is consistently growing. Proper regulatory system ensures the quality, safety and efficacy and standard of medicinal product for sales, importing and manufacturing. India's pharmaceutical industry is one of the most highly regulated industries in the country. Understanding the regulatory scenario is extremely crucial due to the rapid and ongoing changes and due to the burden on the regulatory bodies to ensure a healthy supply of quality drugs at affordable prices to the Indian masses.

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“…The detailed description how it is carried out is described in respective WHO document and national regulatory guidelines. Well resourced regulatory authorities require that a generic medicine must meet certain regulatory criteria [3,4]. The major regulatory requirement for generic drug is presented in Table 1.…”

Section: Pharma Regulations For Generic Product In India and Usmentioning

confidence: 99%

Pharma Regulations for Generic Drug Products in India and US: Case Studies and Future Prospectives

Swain¹,

Dey²,

Patra³

et al. 2014

Pharmaceut Reg Affairs

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Among the developing nations of the world, India has already carved out a special niche for itself in many business verticals of the pharmaceutical industry and is currently being recognized as the 'pharmacy of the world' for the generic drug products. The Indian generics market is growing day by day with Indian pharmaceutical companies seeking more Abbreviated New Drug Application approvals (ANDAs) in US. Generic medicines are formulated when patent and other exclusivity rights expire. To ensure the therapeutic efficacy of generic products, it must be pharmaceutically interchangeable and bioequivalent to the originator product. The contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world is very high i.e. about to 35%. To sustain competition from developed world Indian generic manufacturer should plan the market strategy and regulatory requirement needed, very quickly because for generics production large number of application will be filed and competition from domestic market will also be there. This review enlists the validated regulations for manufacturing of generic drugs in India and US. Implementation and regulation, of the pharmaceutical sector at the state level, rather than on simply introducing new regulations is call of the hour. Henceforth, the use of drugs needs to be emphasized significantly for cost savings to the government and customers, in addition to its optimistic impact on health.

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An Update On the Generic Drug Approval Process

Cited by 5 publications

References 0 publications

Generic Drug Development and Current Scenario

Generic Drug Development and Current Scenario

EVALUATION OF PHARMACEUTICAL REGULATORY SYSTEM & PRESENT SCENARIO OF INDIAN PHARMACEUTICAL INDUSTRY

Pharma Regulations for Generic Drug Products in India and US: Case Studies and Future Prospectives

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