TOP 10 PHARMA COMPANIES IN INDIA 2017?

TOP 10 PHARMA COMPANIES IN INDIA 2017?

✔Pharmaceutical sector is a swiftly growing industry in the country and India stand among the top 5 pharmaceutical markets in the world. For the past few years, the awareness regarding health and hygiene has increased, which has led to increase in the sale of pharmaceutical products in India.

✔The total revenue generated by pharmaceutical companies in India in the last financial year was more than $20 Billion, which is expected to cross the mark of $26 Billion by 2017. The pharmaceutical sector of India ranks third worldwide in terms of volume.

✔The pharma companies in India have been serving the Indian masses since time unbeknownst. And when it comes to best companies, there is a tiff between many firms. Here in this article we have focused solely on the parameter of markte capitalisation.

✔Pharmaceutical companies produces drugs and vaccines for various domains like cardiology, nephrology, neurology, diabetology, etc. This post describes about the Top 10 Pharma Companies in India 2017, here have a look! (Jan 2017)🤔

10. Torrent Pharma

Torrent Pharmaceuticals Ltd. is a flagship company of the torrent group which was started in the year 1969. It was later that the company got acquired by the Heumann GmbH, a Pfizer group.

The company operates in more than 50 countries and has been ranked as tenth in the list of Top 10 Pharma Companies in India 2017. It owns nearly 7 fully owned subsidiaries. The company is one of the dominant player in therapeutic, gynaecology and paediatric segments.

⏳💰Market Capitalization: Rs 22,742 Crore.

9. GlaxoSmithKline

GlaxoSmithKline (GSK) Pharmaceuticals Limited, a leading pharma company is the Indian subsidiary of GlaxoSmithKline, a British Pharmaceutical Giant.

Headquartered in Mumbai, GlaxoSmithKline Pharmaceuticals Limited was established in the year 1924 and stand among the oldest pharmaceutical companies in India. GSK India offer products for various therapeutic areas, which are Dermatology, Cardiology, Respiratory etc.

Market Capitalization: Rs 23,010 Crore

8. Glenmark

Winner of Best Pharma Company in Emerging Markets Award, Glenmark Pharmaceuticals is placed at eighth in the list of Top 10 Pharma Companies in India 2017. Glenmark came into existence in the year 1977 and presently operates in more than 90 countries across the globe.

⏳💰Market Capitalization: 25,302 Crore

7. Piramal Entreprises

Piramal Enterprises Limited which was previously known as Piramal Healthcare Limited, is a part of Piramal Group.

The company’s total income was accounted as of March 2016 was 4,056 crores. It has headquarters situated in Mumbai. The company also forays its presence in financial services and information management sectors.

Market Capitalization: Rs 30,975 Crore

6. Cadila Pharmaceuticals Limited

Cadila Pharmaceuticals Limited with a market capitalization of Rs 31,631 Crore is next on this list. Headquartered in Ahmedabad, Cadila Pharmaceuticals Limited was established in the year 1951 and presently operates in over 80 countries in the world.

Cardiology, Respiratory, Gastroenterology and Neurology are some of the therapeutic areas, of which the company offer products. The company has a large production capacity with a production capacity of more than3,500 Million Tables and over 120 Million Capsules per year.

Market Capitalization: Rs 31,631 Crore

5. Aurobindo Pharma Limited

Aurobindo Pharma Limited is ranked fifth in the list of Top 10 Pharma Companies in India 2017. Incorporated in the year 1986, Aurobindo Pharma Limited started operations in India in 1988-99 with the establishment of the first manufacturing unit in Pondicherry.

Aurobindo is a big pharmaceutical company with 6 manufacturing units in India and operations in more than 120 countries in the world. Neurology, Nephrology, Cardiology and Gastroenterology are some of the therapeutic areas, of which the company provide products.

Market Capitalization: Rs 41,283 Crore

4. Cipla

4th position on this list has been by Cipla, a leading pharmaceutical company incorporated in the year 1935 and presently has operations in more than 150 countries.

Headquartered in Mumbai, Cipla is a swiftly growing pharma company and employ more than 20,000 people.

Cipla produces more than 2,000 products and owns more than 30 manufacturing plants in different parts of the country. Some of the areas, of which Cipla offer products include Cardiology, Neurology, Nephrology and Diabetology.

Market Capitalization: Rs 47,319 Crore

3. Dr. Reddy’s Laboratories

With a market capitalization of Rs 49,293 Crore, Dr. Reddy’s Laboratories is the next pharmaceutical company in this list. Founded in the year 1984, Dr. Reddy’s Laboratories within a few decades has emerged as a leading pharmaceutical company in India.

The company produces more than 200 pharmaceutical products and operates in more than 20 countries across the globe. Dermatology, Cardiology, Gastroenterology and Pediatrics are some of the therapeutic areas, of which the company offers pharmaceutical products.

Market Capitalization: Rs 49,293 Crore

2. Lupin

 Lupin is another leading pharmaceutical company and stand at second in the list of Top 10 Pharma Companies in India 2017. Incorporated in the year 1968, Lupin is one of the fastest growing and best pharmaceutical companies in India.

The company produces more than 5,500 pharmaceutical products of premier quality. Some of the therapeutic areas, of which the company offer products are Neurology, Cardiology, Diabetology and Orthopedics.

Market Capitalization: Rs 68,031 Crore

 1. Sun Pharmaceutical Industries Ltd.

Among all pharmaceutical companies in India, Sun Pharmaceutical Industries Limited is the leader. Established in the year 1983 by Dilip Shanghvi, Sun Pharmaceuticals operates in more than 150 countries across the world.

In the year 2014, Sun Pharmaceuticals acquired Ranbaxy Laboratories Limited and became the largest pharmaceutical company in India and the fifth largest pharmaceutical company in the world.

Sun Pharmaceuticals has manufacturing units in many countries, that include India, USA, South Africa, Canada, Ireland, Malaysia and Mexico. It also has Research and Development (R&D) centres in India, USA, Israel and Canada.

The company offers various quality pharmaceutical products for different domains and some of the area are Diabetology, Neurology, Cardiology, Gastroenterology and Orthopedics

Market Capitalization: Rs 1,55,716 Crore

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GMP Violations @ FDA warning letter

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, USV Private Limited at H-17/H-18, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman from June 1 to 10, 2016.

 

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

 

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

 

We reviewed your July 1, 2016 response in detail and acknowledge receipt of your subsequent correspondence.

 

During our inspection, our investigators observed specific violations including, but not limited to, the following.

 

1.    Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

 

For example, during inspection of the QC microbiology testing laboratory, our investigators observed:

 

A.  No growth on the positive control plate for media used to test microbiological (b)(4) samples. When a positive control fails to yield growth, test results cannot be considered valid due to the potential for false negatives.

 

B.  Desiccation of a contact media plate used during environmental monitoring of the sterility testing area. Desiccated, cracked, or otherwise damaged (b)(4)  compromises microbial growth promotion and accurate enumeration, and can lead to artificially low microbiological counts and false negatives. Using deficient media compromises the validity of your microbiological test results.

 

Also, you did not appear to routinely identify (i.e., to species level) bacterial and fungal isolates recovered during environmental monitoring of your aseptic processing room.

 

C.  Air bubbles between filtration (b)(4)  and (b)(4)  plates in 13 out of (b)(4)  microbiological (b)(4)  system sampling plates. Inadequate contact between the filter (b)(4)  and the (b)(4)  plate may compromise recovery.

 

Your response indicates that you evaluated the impact of these laboratory deviations and believe they pose a low risk. The response lacks a commitment to perform a comprehensive evaluation of your microbiology laboratory controls and practices.

 

2.    Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

 

During review of your 2014 smoke studies, our investigators observed turbulent air flow in the ISO 5 area on the (b)(4)  vial filling and capping production line at approximately 09:53 and 10:39 minutes.

 

In your response, you state that you have performed new smoke studies and that these new studies demonstrate unidirectional airflow during manual interventions. However, your response is inadequate because you did not assess past occurrences of deficient airflow in smoke studies or provide corrective actions to your process design to resolve these issues. You also did not provide copies of the recent dynamic smoke studies.

 

In response to this letter, include a thorough retrospective review of smoke studies and a CAPA plan to address all deficiencies.

 

3.    Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

 

For example, during inspection of the sterile manufacturing and QC microbiology areas, our investigators observed:

 

A.  Deletion of at least six (b)(4) and (b)(4) tests in the audit trails for two instruments used to test sterile (b)(4). Your systems allowed operators to delete files. You had no procedure to control this practice or to ensure a backup file was maintained. When you reviewed the audit trail data further, you identified a total of 25 deleted (b)(4) test results. In your response, you state that the production staff now only have “view and print” privileges. However, your response is inadequate because it lacks details of how appropriate oversight will be exercised over data backup to ensure it is appropriately retained.

 

B.  No restricted access to the microbial identification instrument. Further, you lacked restricted access to the external hard drive used for backup of this instrument. All users could delete or modify files. In your response, you commit to limit access to the system and external hard drive. However, your response is inadequate because you did not provide a retrospective risk assessment of the impact and scope of inadequate system controls at your firm.

 

4.    Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).

 

(b)(4) failed identity testing. You accepted a passing retest result without any investigation of the failed result.

 

In your response, you state that you attempted to conduct a retrospective investigation of the analysis which occurred more than a year earlier, and tentatively concluded that the out-of-specification (OOS) result might have been caused by analyst error. Also, your investigation recommends replacement of the polarimeter on which the OOS result was obtained.

 

Your response did not include a commitment to revisit the adequacy of your OOS procedures. When an OOS result is obtained, initiation of a prompt laboratory investigation is critical. In addition, you must provide all data obtained during testing to the quality unit for batch record review. If the laboratory invalidates an OOS result, it is essential that the batch record include the relevant investigation. Only a scientifically sound and conclusive investigation can justify the exclusion of an OOS result from the final certificate of analysis.

Source: FDA

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Dr.Reddy’s gets 13 observations from USFDA for Visakhapatnam plant

On Wednesday, shares of Dr.Reddy’s fell 0.04% to Rs2,851.40 on BSE, while the benchmark Sensex shed 0.34% to 28,901.94 points. 

Mumbai: The US Food and Drug Administration (FDA) has made 13 observations relating to deviation from good manufacturing practices at Dr.Reddy’s Laboratories Ltd’s cancer formulations facility at Duvvada in Visakhapatnam, the company said in a stock exchange filing on Wednesday.

“The audit of our formulation manufacturing plant at Duvvada, Visakhapatnam, by the USFDA, has been completed today (8 March, 2017). We have been issued a Form-483 with 13 observations, which we are addressing,” the company said.

Dr.Reddy’s did not give details on nature of the observations.

The FDA issues a Form-483 if its investigators spot any conditions that in their judgment may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.

“This is a negative development as the number of observations is high despite the remedial measures taken by Dr.Reddy’s after receiving the warning letter. Duvvada plant is newer but USFDA is very strict as far as injectables are concerned. I believe that remediation process will take at least one to one-and-a-half years and this will impact future product filings and approvals in the US,” said Surajit Pal, an analyst at Prabhudas Lilladher.

On 21 February, the company’s active pharmaceutical ingredients (API) manufacturing plant at Miryalaguda in Telangana was issued a Form-483 by the USFDA with three observations relating to violation of norms.

In November 2015, the Hyderabad-based drug maker had received warning letter from the USFDA for breach of norms at formulation plant at Duvvada, and API facilities at Miryalaguda and Srikakulam.

In mid-January, Dr.Reddy’s had said that “all the commitments as part of warning letter response have been completed and the three plants will be re-inspected by the US regulator by end of March.”

After receiving the warning letter, the pharmaceutical major submitted five responses to the USFDA at regular intervals, giving updates on the remedial work undertaken at the three plants. The company also hired an independent consultant to resolve the compliance issues at these units.

The warning letter had an adverse impact on the company’s earnings as new product approvals in the US from these sites were put on hold. The US market accounted for nearly half of Dr.Reddy’s total revenue of Rs15,470 crore in the year ended March 2016.

On Wednesday, shares of Dr.Reddy’s fell 0.04% to Rs2,851.40 on BSE, while the benchmark Sensex shed 0.34% to 28,901.94 points.

Source: Livemint: Isha Trivedi

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GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.

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Divi’s Lab shares fall 20% after USFDA import alert for Visakhapatnam plant

Divi’s Lab shares fall after USFDA issued an import alert on company’s unit-II of the Visakhapatnam plant due to violation of good manufacturing practices.

The import alert for Divi’s Lab means products manufactured in the unit will not be allowed to be marketed in the US. The US drug regulator has, however, exempted 10 drugs from the import ban.

Mumbai: Shares of Divi’s Laboratories Ltd plunged 20% as the US Food and Drug Administration (USFDA) issued an import alert on the company’s unit-II of Visakhapatnam plant in Andhra Pradesh due to violation of good manufacturing practices.

At 11:05am, the stock was trading at Rs650 on the BSE, down 17.8% from the previous close, while the benchmark Sensex index was down 0.2% at 29,470.90 points.

The scrip closed down 19.77% at Rs634.35. The Divi’s Laboratories Ltd shares touched a high and a low of Rs711.65 and Rs628.45, respectively, on BSE.

The import alert means products manufactured in the unit will not be allowed to be marketed in the US. The US drug regulator has, however, exempted 10 drugs from the import ban, Divi’s Lab said in a stock exchange filing.

The company, along with third-party consultants, is currently working to address the concerns of the USFDA and making all efforts to fully meet the compliance requirements, Divi’s Lab said.

“It can take anywhere between two to three years to resolve import alert-related issues. So the company’s earnings will remain under pressure and their customer relationships will also be hurt,” Vishal Manchanda, analyst at Nirmal Bang Securities, said.

The US drug regulator inspected unit-II of the Visakhapatnam plant between 29 November and 6 December 2016 and issued a Form 483 to the unit with five observations relating to deviations from norms.

The five observations were: lack of proper controls over computer systems to ensure drug quality, improper maintenance of facility and equipment, R&D division allowing activities inconsistent with manufacturing norms, failure to investigate batches of products containing impurities and improper maintenance or falsification of records.

North America accounts for 30-32% of the revenue of the active pharmaceutical ingredients and intermediates manufacturing company. In the quarter ended December, Divi’s Lab’s sales were Rs973.44 crore, as against Rs858.65 crore a year ago.

Source: Livemint: Isha Trivedi

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GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.

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What is the Role of Quality Unit? What ICH guideline says?

Easy Learning ICH Q7-Part 3 by Anshu Yadav

Quality Unit-Role and Function

An independent Quality unit is an essential requirement of the ICH guidelines. Thus it is required to know the function of a Quality unit [Section 2.2 of ICH].

     

Handle	All quality related matters.
Review	Validation protocols & report, Quality related document, Batch             Production and laboratory control records before release of API.
Release	APIs, Intermediates, Raw material, Packaging material and labeling                 material.
Reject	APIs, Intermediates, Raw material, Packaging material and labeling             material.
Approve	Specification, Master production Instruction, All procedures          impacting quality of Intermediate/API, Validation protocols &          reports and approving intermediate and contract manufacturers.
Perform	Product Quality Review
Ensure	Critical deviation and quality related complaints are investigated &             resolved, Internal audit are performed
	Effective systems are used for maintaining and calibrating critical            equipment.
	Materials are appropriately tested and results are reported.
	Stability data is there to support retest or expiry dates and storage            condition

The Quality control is responsible for the laboratory control function [Section 11 of ICH].To conduct all the above activity, the quality unit should have an adequate laboratory facilities.

Laboratory control [Section 11 of ICH]  

General Control

·        Documented procedure for all the relevant activities of the Quality Unit [Section 6.6]

·        Scientifically sound test procedure, specification and sampling plans.

·        Specifications which should include

o Appropriate specification in accordance with accepted standard and consistent with the manufacturing process

o Control of Impurity

o Microbiological purity (if applicable) –[Action limit for total microbial counts and objectionable organism should be established]

o Endotoxin(if applicable)

·        The activity should be recorded at the time of performance.

·        All the function mentioned in Section 2.2 of ICH should be followed.

Testing of Intermediate and APIs

Laboratory test are conducted to determine the requirement of specifications are fulfilled or not. The manufacturer should provide adequate laboratory facility to the quality unit. Appropriate microbiological test should be conducted on each batch of intermediate & API where microbial test is required. Impurity profile should be maintained

At regular interval the impurity profile should be challenged against regulatory submission or against historical data. This is required to detect if modification in RM/PM, equipment, operating procedure or the production process.

Exception: Not necessary for herbal/animal tissue origin.

Certificate of analysis:

Quality control should issue certificate of Analysis for an API or Intermediate at the time of releasing the batch. This COA should be shared with customer on request. 

Elements of COA

·        Name of Intermediate or API

·        Batch Number

·        Date of release

·        Expiry Date or Retest date as applicable

·        List of Test performed with acceptance criteria and the result obtained

·        Dated and signed by authorized personnel

·        Name address and telephone number of the original manufacturer

Note: If Analysis is done by repacker or reprocessor, name, address and telephone no. of repacker or reprocessor should be mentioned on COA with the reference to original manufacturer.

            If new certificate are issued by or on behalf of the repacker or reprocessor, agents or brokers, the certificate should mentioned name address and telephone no. of the laboratory that performed the analysis. Reference to the name and address of the original manufacturer and to the original batch certificate copy should be attached.

Validation of Analytical procedure

Analytical method should be validated unless the method used is included in relevant pharmacopeia or other recognized standard reference. The analytical method should be validated on the qualified equipment. However the suitability of all testing method used should be verified under the condition where the method is used and should be documented. In case there is any modification in the validated analytical it should be documented and complete record should be maintained.

Stability Monitoring of APIs

·     Stability Monitoring is required for API.

·     Stability Monitoring is an ongoing testing program to monitor the characteristic of the             API and to confirm appropriate storage condition and retest or expiry dates.

·     The procedure for stability testing should be validated and documented.

·      Stability Sample should be stored in container similar to the market container.

·   The first three commercial batches should be placed for stability to confirm retest and            expiry dates but if the data is available from previous studies that API is stable for at least    two years then fewer batches are acceptable for stability keeping.

Expiry/Retest date

If an intermediate is transferred outside the control of manufacturer’s material management system and an expiry or retest date is assigned can be in form of published data or test result.

The expiry or retest date of the API & intermediate should be based on evaluation of data derived from stability studies. Usually a retest data is used not an expiry date. When the commercial production is not initiated the expiry or retest dates can be based on the pilot scale production if:

·   The method and procedure simulates the final method and procedure of the commercial manufacturing scale.

·    The quality of the final product is equivalent to the material made on the commercial scale. 

Reserve/Retention sample:

Reserve/Retention sample are one and the same thing. These are kept for potential evaluation of the quality of batches of API. The sample should be kept either one year after the expiry date or for 3 years after the distribution of batches, whichever is longer. Similar packaging system should be used in which the API is dispatched or in packaging system which is more protective. The quantity stored should be equal to at least two full compendial analysis or two full specification analysis (in absence of pharmacopeia monograph)

Author – Anshu Yadav

Manager QA at Sharp Mint Limited.

Qualification: Masters in Industrial Biotechnology Management from Lille Catholic UniveersitySpecialization in QHSE in food and Pharmaceutical Industry.

Next Article Title:  Sampling

   

My Articles: ICH @ Change control, Complaints and contract manufacturing?

Any query or suggestions please write your comments at comments section..

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GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.

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