Content about MUMBAI

April 10, 2014

Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths.

MUMBAI and BALTIMORE — Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths. The product is the generic version of Actos tablets from Takeda Pharmaceuticals.

The drug is used an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. Actos tablets had annual sales in the United States of approximately $236 million as of December 2013, according to IMS MAT data. 

 

April 7, 2014

Sun Pharma on Sunday announced it will acquire 100% of Ranbaxy in an all-stock transaction valued at $4 billion.

MUMBAI, India — Sun Pharma on Sunday announced it will acquire 100% of Ranbaxy in an all-stock transaction valued at $4 billion. 

The combination of Sun Pharma and Ranbaxy creates the fifth-largest specialty generics company in the world and the largest pharmaceutical company in India, Sun Pharma stated. The combined entity will have operations in 65 countries, 47 manufacturing facilities across five continents, and a significant platform of specialty and generic products marketed globally, including 629 abbreviated new drug applications. 

March 21, 2014

Pharma Major Lupin announced that Lupin Pharmaceuticals, its U.S. subsidiary, has launched niacin extended-release tablets USP in 500-mg, 750-mg and 1,000-mg strengths.

MUMBAI and BALTIMORE — Pharma Major Lupin announced that Lupin Pharmaceuticals, its U.S. subsidiary, has launched niacin extended-release tablets USP in 500-mg, 750-mg and 1,000-mg strengths.

The drug is the generic version of AbbVie’s Niaspan tablets. It's used to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia, the company said.

March 6, 2014

Lupin on Thursday announced that it received final approval from the Food and Drug Administration for both its doxycycline capsules and its ciprofloxacin for oral suspension.

MUMBAI and BALTIMORE — Lupin on Thursday announced that it received final approval from the Food and Drug Administration for its doxycycline capsules USP, 50 mg, 75 mg and 100 mg, which is the generic version of Aqua Pharmaceuticals' Monodox capsules. The drug is used to treat infections caused by various microorganisms and as an adjunctive therapy in severe acne, according to the company.

February 28, 2014

Lupin announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150-mg, a generic version of Pharmacia and Upjohn Company's Mycobutin capsules.

MUMBAI and BALTIMORE — Lupin on Wednesday announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150 mg — a generic version of Pharmacia and Upjohn Company's Mycobutin capsules. The company's U.S. subsidiary will begin marketing the product soon.

The drug is used for the prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection. Mycobutin capsules had annual sales of $18.6 million in the United States, according to IMS MAT.

 

February 18, 2014

Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

MUMBAI — Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

February 3, 2014

Mylan on Monday announced that its subsidiary has launched the world's first trastuzumab biosimilar in India, which will be marketed by Mylan as Hertraz.

MUMBAI and PITTSBURGH — Mylan on Monday announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched the world's first trastuzumab biosimilar in India. The product — which will be marketed by Mylan as Hertraz — is used for the treatment of HER2-positive metastatic breast cancer. Hertraz is a biosimilar to Roche's Herceptin and is available in two strengths:  440mg and 150mg.

January 31, 2014

Mylan announced that its India-based subsidiary, Mylan Pharmaceuticals Private Limited, has been named Gilead Sciences' branded medicines business partner for India.

PITTSBURGH and MUMBAI, India — Mylan announced that its India-based subsidiary, Mylan Pharmaceuticals Private Limited, has been named Gilead Sciences' branded medicines business partner for India.

Under this exclusive agreement, Mylan will market and distribute in India the following drugs from Gilead:

September 16, 2013

The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

MUMBAI, India — The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

Sun announced the approval of lansoprazole delayed-release capsules in the 15-mg and 30-mg strengths.

The drug is a generic version of Takeda's Prevacid delayed-release capsules, which are used for treatment lasting up to four weeks for healing and symptom relief of active duodenal ulcers.

Various versions of the drug have annual sales of about $430 million per year, according to Sun.

 

July 23, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Lupin, the company said.

MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Lupin, the company said.

Lupin, based in India, received approval for metformin hydrochloride extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Santarus' Glumetza.

Glumetza had sales of about $144 million during the 12-month period that ended in March, according to IMS Health. The drug is an extended-release formulation of metformin hydrochloride, a widely prescribed drug used for treating Type 2 diabetes.

 

July 12, 2013

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Sun Pharmaceutical Industries, Sun said Friday.

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

April 19, 2013

The Food and Drug Administration has given tentative approval to two generic diabetes drugs made by Sun Pharmaceutical Industries, the Indian drug maker said.

MUMBAI, India — The Food and Drug Administration has given tentative approval to two generic diabetes drugs made by Sun Pharmaceutical Industries, the Indian drug maker said.

Sun announced the tentative approvals for sitagliptin tablets in the 25 mg, 50 mg and 100 mg strengths and metformin hydrochloride extended-release tablets in the 500 mg and 1,000 mg strengths. The drugs are respectively generic versions of Merck's Januvia and Santarus' Glumetza.

April 12, 2013

The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

MUMBAI, India — The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

Lupin announced the approval of Daysee (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) in the 0.15-mg/0.03-mg and 0.01-mg strengths.

The drug is a generic version of Teva's Seasonique. Various versions of the drug had sales of $161 million in 2012, according to IMS Health.

 

October 18, 2012

The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

August 28, 2012

The Food and Drug Administration has determined that generic drug maker Caraco is in compliance with relevant paragraphs of the consent decree and may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Mich., Caraco's parent company Sun Pharmaceutical Industries said.

MUMBAI, India — The Food and Drug Administration has determined that generic drug maker Caraco is in compliance with relevant paragraphs of the consent decree and may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Mich., Caraco's parent company Sun Pharmaceutical Industries said.

During their inspection, the FDA reviewed the certification reports for heart failure treatment Carvedilol USP, as well as antibiotic Paramomycin USP, and determined Caraco may resume production of only these two drugs.

August 15, 2012

The Food and Drug Administration has approved a drug for enlarged prostate made by generic drug maker Wockhardt, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for enlarged prostate made by generic drug maker Wockhardt, the company said.

Wockhardt, based in Mumbai, India, announced the approval of alfuzosin hydrochloride extended-release tablets in the 10-mg strength, which is designed to treat enlarged prostate, also known as benign prostatic hyperplasia.

The drug is a generic version of Sanofi's Uroxatral. Various versions of the drug have sales of about $81.5 million, according to IMS Health.

August 13, 2012

Sun Pharmaceutical Industries will take Taro Pharmaceutical Industries private, under a merger agreement between the two companies announced Sunday.

MUMBAI, India — Sun Pharmaceutical Industries will take Taro Pharmaceutical Industries private, under a merger agreement between the two companies announced Sunday.

Sun, based in India, has sought to buy Israel-based Taro since 2007 and owns about 77.5% of the latter's shares.

After the merger is complete, Taro will become a privately held company and wholly owned subsidiary of Sun. Taro shareholders will receive $39.50 per share.

May 29, 2012

Generic drug maker Sun Pharmaceutical Industries appointed a new chairman as the company announced big jumps in fourth-quarter and fiscal year 2012 sales and profits.

MUMBAI, India — Generic drug maker Sun Pharmaceutical Industries appointed a new chairman as the company announced big jumps in fourth-quarter and fiscal year 2012 sales and profits.

The drug maker announced the appointment of former Teva Pharmaceutical Industries president and CEO Israel Makov as chairman. Makov, who began working for Teva in 1995, and led it as president and CEO from 2002 to 2007, is widely credited with that company becoming the world's largest generic drug maker and one of the world's largest drug makers overall.

April 25, 2012

Sun Pharmaceutical Industries has launched a generic version of a drug used to treat psychiatric disorders, the company said.

MUMBAI, India — Sun Pharmaceutical Industries has launched a generic version of a drug used to treat psychiatric disorders, the company said.

Sun announced the launch of olanzapine tablets in the 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg strengths.

The drug is a generic version of Eli Lilly's Zyprexa, used to treat schizophrenia and bipolar disorder. The branded drug and generic versions had sales of $3.28 billion during the 12-month period ended in January, according to IMS Health.

 

February 21, 2012

A division of Pfizer is asserting that it incurred nearly $1 billion in damages related to the launch of generic versions of one of its drugs.

MUMBAI, India — A division of Pfizer is asserting that it incurred nearly $1 billion in damages related to the launch of generic versions of one of its drugs.

In a lawsuit filed in the U.S. District Court for the District of New Jersey against Sun Pharmaceutical Industries and Teva Pharmaceutical Industries, Wyeth Pharmaceuticals said it estimated that it suffered damages of $960 million from Sun's and Teva's launches of generic versions of the gastroesophageal reflux disease drug Protonix (pantoprazole).

December 12, 2011

The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

MUMBAI, India — The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

Sun announced the approval of tramadol hydrochloride extended-release tablets, a generic version of Valeant International's Ultram ER. The drug is used to treat moderate to moderately severe chronic pain in adults who need constant treatment for an extended period of time.

Various versions of the drug have annual sales of $125 million, according to Sun.

October 4, 2011

A wave of patent expirations over the next several years will open up a broad swath of drugs to generic competition, and India's Lupin Pharmaceuticals is looking to benefit, according to published reports.

NEW YORK — A wave of patent expirations over the next several years will open up a broad swath of drugs to generic competition, and India's Lupin Pharmaceuticals is looking to benefit, according to published reports.

The Wall Street Journal reported that the Mumbai-based company planned to launch 25 to 30 new generic drugs each year over the next couple of years.

October 4, 2011

Sun Pharmaceutical Industries last month said that it has resolved issues cited in a warning letter sent to the company by the Food and Drug Administration pertaining to one of Sun Pharma's U.S.-based manufacturing facilities.

MUMBAI, India — Sun Pharmaceutical Industries last month said that it has resolved issues cited in a warning letter sent to the company by the Food and Drug Administration pertaining to one of Sun Pharma's U.S.-based manufacturing facilities.

September 15, 2011

LifeScan on Thursday kicked off the global launch of its new blood-glucose monitoring device specifically designed to make self-monitoring simple.

MUMBAI, India — LifeScan on Thursday kicked off the global launch of its new blood-glucose monitoring device specifically designed to make self-monitoring simple.

August 18, 2011

Generic drug maker Sun Pharmaceutical Industries has received regulatory approval for a drug designed to treat an enlarged prostate.

MUMBAI, India — Generic drug maker Sun Pharmaceutical Industries has received regulatory approval for a drug designed to treat an enlarged prostate.

According to the Food and Drug Administration's website, Sun Pharma's finasteride tablets in the 5-mg strength were approved on Aug. 16.

Finasteride is the generic equivalent of Proscar and Propecia, which are made by Merck.