Friday, 21 March 2014

AXIS Clinicals announces successful completion of 13th US FDA Audit

AXIS Clinicals announces successful completion of 13th US FDA Audit
Friday, 21 March 2014

Hyderabad, INDIA – AXIS Clinicals Limited, the leading Clinical Research Organization (CRO), announces today that its Hyderabad, India based Clinical Pharmacology Units (CU-I and CU-II) successfully completed its 13th US FDA Audit without 483s / observations. US FDA Investigator audited the First-to-File studies for one of AXIS Clinicals’ sponsor. The audit covered the review of several studies, general processes and systems inspection.

The latest US FDA Audit with NO 483’s is a resounding success for AXIS Clinicals Team. Having a successful US FDA audit for the First-To-File product, along with the Brazilian ANVISA, UK MHRA, France-AFSSAPS, Turkey MOH and NABL certification, demonstrates that AXIS Clinicals has attained the Quality Standards laid by international regulatory bodies.

AXIS Clinicals continued successful audit track record confirms that the company's quality system meet the requirements established by the US, Canada, Europe, Brazil, Australia, South Africa, Turkey, Malaysia and other international regulatory authorities.

About AXIS Clinicals

AXIS Clinicals Limited is a Contract Research Organization headquartered in Hyderabad, India with the global footprint of operations in United States, Mexico and Thailand, committed to serving the biopharmaceutical industry with the global standards and most accurate results. AXIS Clinicals specializes in the conduct of Bioequivalence / Bioavailability studies, Phase / Clinical Trials and bioanalysis for innovative pharmaceutical, biotech and medical device companies. AXIS Clinicals has completed 1500+ studies for global regulatory submissions.

AXIS Clinicals has the world-class infrastructure with 292-bed clinical facility and a co-located bioanalytical laboratory in Hyderabad, India.

About First-To-File product:

The first-to-file status comes with 180-day marketing exclusivity (from the date of approval of the ANDA). During this exclusivity period, the first-to-file generic company can realize enormous profits on the sale of the generic drug before other generic product enter the market.

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Wednesday, 31 July 2013

AXIS Clinicals goes global

AXIS Clinicals goes global
v  Starts largest CRO facility in Mexico spread over 4000m2
v  100-bed facility with modern bio-analytical & reference labs

Hyderabad, Jan. 15, 2013: AXIS Clinicals Group, a leading Clinical Research Organization (CRO) announces the commencement of it’s operations at Mexico. With this facility, AXIS Clinicals Group now has three centers spread in India & overseas and can offer clinical research solutions to global clients.

This new center is the largest CRO facility in Mexico with bio-analytical and reference labs all housed in the same building that is spread over 4000 sq meters. The Mexico center is a 100-bed clinical facility that can grow to 160-beds and has over 50 employees with eight doctors all recruited from prestigious local universities. Over 300 methods have been developed on a global basis including hormonal, oncology and biotechnological products. Separate ambulatory area and sampling area with reclining reposers are also some of the key facilities at the centre.

It is the only CRO facility in Northern Mexico City with a database of 5000 healthy volunteers, thus minimizing risk of cross participation. It has received the COFEPRIS license approval in record time and has four LCMS machines in its bio-analytical division with a capacity to go up to 15 LCMS. The centre is equipped to handle phase II-IV studies and has a database of 2000 investigators. It has already been contracted for 75 studies from multinational, big pharma clientele as well as large local Mexican laboratories. It is an active member of AMETA - Mexican CRO Industry Association.

AXIS Clinicals Limited, one of India’s leading CRO is committed to serving the biopharmaceutical industry by leveraging two powerful trends impacting the world of Clinical Research - globalisation and full spectrum offering. Established in September 2004, the company has completed over 1500 clinical studies, 300 ANDA studies and received 50 product approvals from regulatory agencies. The company facilities have been accredited by DCGI (Drugs Controller General, India), NABL (National Accreditation Board for Testing and Calibration Laboratories - ISO 15189:2003) and inspected by US-FDA, UK-MHRA, Brazil-ANVISA and France AFSSAPS and conforms to ICH and CDSCO-GCP & GLP Guidelines. For further details, please visit –

Wednesday, 13 March 2013

Facts about Generic Drugs

Today, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent through 2015. Here are some facts about generic drugs:  

FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs.  
When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.  
Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product.   
The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured.  If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.  
Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.  
All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products. 

FACT:  Research shows that generics work just as well as brand name drugs.
A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand name heart drugs worked any better than generic heart drugs.[1]  

FACT:    FDA does not allow a 45 percent difference in the effectiveness of the generic drug product.  
FDA recently evaluated 2,070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was 3.5 percent[2]. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name drug. In fact, there have been studies in which brand name drugs were compared with themselves as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison. 
Any generic drug modeled after a single, brand name drug must perform approximately the same in the body as the brand name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product. 

FACT: When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85 percent lower than the brand name product. 
In 2010 alone, the use of FDA-approved generics saved $158 billion, an average of $3 billion every week.[3] 

FACT: Cheaper does not mean lower quality.  
Generic manufacturers are able to sell their products for lower prices because they are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. In addition, multiple generic companies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices. 

FACT: FDA monitors adverse events reports for generic drugs. 
The monitoring of adverse events for all drug products, including generic drugs, is one aspect of the overall FDA effort to evaluate the safety of drugs after approval. Many times, reports of adverse events describe a known reaction to the active drug ingredient.  
Reports are monitored and investigated, when appropriate. The investigations may lead to changes in how a product (brand name and generic counterparts) is used or manufactured.   

FACT:  FDA is actively engaged in making all regulated products – including generic drugs – safer.
FDA is aware that there are reports noting that some people may experience an undesired effect when switching from brand name drug to a generic formulation or from one generic drug to another generic drug. FDA wants to understand what may cause problems with certain formulations if, in fact, they are linked to specific generic products.   
FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur. The Agency does not have the resources to perform independent clinical studies and lacks the regulatory authority to require industry to conduct such studies. FDA will continue to investigate these reports to ensure that it has all the facts about these treatment failures and will make recommendations to healthcare professionals and the public if the need arises.  

[1] Kesselheim et al. Clinical equivalence of generic and brand name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21)2514-2526
[2] Davit et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009;43(10):1583-97.
[3] SAVINGS An Economic Analysis of Generic Drug Usage in the U.S., GPhA, September 2011, page 1.