Cipla Receives USFDA Approval for Generic Voltaren® Gel (Diclofenac Sodium Topical Gel, 1%)

Press Release

Cipla Limited (“Cipla”) announced that it has received final approval on August 3, 2018, for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 1% from the United States Food and Drug Administration (US FDA).

Cipla’s Diclofenac Sodium Topical Gel, 1% is AB-rated generic therapeutic equivalent to the reference listed drug (RLD), Voltaren® Gel, 1% of GlaxoSmithKline Consumer Health®. It is a non-steroidal anti-inflammatory drug
indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

According to IQVIA (IMS Health), Voltaren® Gel and its generic equivalents had US sales of approximately $353M for the 12-month period ending June 2018. The product will be available for shipping in the US in the upcoming week.

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We wish you a very happy 72nd Indian Independence Day!

Seven decades after our historic tryst with destiny, on 15 August 2018, India will celebrate 72 years of independence, democracy and sovereignty. Presenting some interesting snippets from the archives on this occasion.

“India was officially proclaimed independent on 15th August 1947 with much celebrations in Delhi and other towns. Cipla celebrated the first Independence Day by a flag hoisting ceremony where all workers and staff of Cipla were present.”

– Dr. Khwaja Abdul Hamied,
Founder, Cipla.
‘A Life To Remember – An Autobiography’ (1972)


This is how India’s first Independence Day was celebrated by Cipla. The tricoloured Indian national flag was proudly unfurled and hoisted and the venue was Cipla’s very first manufacturing site and headquarters in Mumbai Central.

Seen here, Cipla Founder, Dr. K.A. Hamied, with his two young sons Dr. Y.K. Hamied and Mr. M.K. Hamied along with the factory staff and workers.


Cipla’s celebration of Indian independence did not end there. As a nationalist and freedom fighter, Dr. K.A. Hamied ensured that Cipla as an employer played its part in making the occasion unforgettable for Ciplaites by announcing a generous Independence Bonus!

The late Dr. A.R. Kidwai was a multi-faceted personality – public servant, scholar, statesman extraordinaire of post-independence India. Dr. Kidwai was a Cipla chemist from 1941 to 1945 and was witness to early scientific projects of Cipla as well as the involvement of then Ciplaites in the independence movement. Here’s a snippet of his reflections from the Oral History collection of the archives.

This advertisement placed by Cipla in the 1948 edition of the journal, Marg is a strong reminder of how Cipla was a trail-blazer in pharma R&D, quality and manufacturing in India, and saw itself as second to none. Spend a minute or two to read it with its context in mind – a time of euphoria, great promise, unrealised potential. A time when the state of India would finally attain equality in status with others on the world stage. Cipla’s strides were a microcosm of India’s in so many ways.


On that note, we wish you a very happy 72nd Indian Independence Day!

Cipla Receives Final Approval for Generic Reyataz® (Atazanavir Caps 100mg, 150mg, 200mg, 300mg)

Press Release

Cipla Limited (“Cipla”) today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Atazanavir Caps 100mg, 150mg, 200mg, 300mg from the United States Food
and Drug Administration (US FDA).

Cipla’s Atazanavir Caps 100mg, 150mg, 200mg, 300mg is AB-rated generic therapeutic equivalent version of Bristol-Myers Squibb Pharma Company’s, Reyataz®. It is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients with minimum age of 6 years and older weighing at least 15 kg.

According to IQVIA (IMS Health), Reyataz® and its generic equivalents had US sales of approximately $324M for the 12-month period ending April 2018.

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Cipla partners with MSN Laboratories for marketing and distribution of generic Xeloda® (Capecitabine Tabs 150mg and 500mg)

Press Release

Cipla USA, Inc., (“Cipla”) a subsidiary of Cipla Limited, today announced that it has secured rights from MSN Laboratories Private Limited to market & distribute Capecitabine 150mg and 500mg tablets in the United States of America. The product is available immediately.

The Capecitabine 150mg and 500mg tablet is an AB-rated generic therapeutic equivalent version of Genentech’s Xeloda®. Capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred, and also indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

As per IQVIA (IMS Health), Xeloda® and its generic equivalents had sales of approximately $178M for the 12-month period ending June 2018 in the United States.

About MSN Group
Founded in 2003 with a mission to make health care affordable, the MSN Group based out of Hyderabad is one of the fastest growing research-based pharmaceutical company in India. MSN has 10 API (including Oncology) and
five finished dosage facilities out of which three in Hyderabad, one both in USA & Myanmar. MSN Labs has an integrated R&D Center for both API and product formulation under one roof. The company’s core strategy will be to focus on high barrier of entry & first to market paragraph 4 products. MSN customer base exceeds 250 customers with a global presence in 65 countries throughout US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. With more than 350 National & International patents filed, MSN’s product basket offers 300 APIs & 200 Formulations covering 35 major therapies.
http://www.msnlabs.com

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Belarusian specialists promised career enhancement at innovative Indian pharmaceutical enterprises

Belarusian specialists will be able to improve their skills at innovative Indian pharmaceutical enterprises. The statement was made by Yusuf Khwaja Hamied, Non-Executive Chairman of the Indian company Cipla Limited, before he met with Chairman of the Council of the Republic of the National Assembly of Belarus Mikhail Myasnikovich on 7 August, BelTA has learned. Mikhail Myasnikovich is in charge of overseeing cooperation with India.

Yusuf Khwaja Hamied outlined cooperation development plans. There are plans to allow Belarusian technical specialists to get trained in India. According to the source, Belarusian specialists will be able to improve their skills at cutting-edge enterprises that make pharmaceutical products. Besides, the meeting in the Council of the Republic of the National Assembly of Belarus also touched upon prospects of establishing an R&D center in Belarus and a manufacturing site after that.

On 6 August Yusuf Khwaja Hamied took part in the ceremony to open a landscape complex in honor of the construction of the pharmaceutical R&D center at premises of the state enterprise Academpharm. The Indian company will invest $1 million in the project initially. The project’s implementation was discussed during the meeting with Mikhail Myasnikovich. The head of the upper chamber of the Belarusian parliament noted that cooperation between Academpharm and Cipla Limited goes beyond making money. “I am talking about scientific and innovative cooperation. Because Academpharm and Cipla Limited have a joint innovative interest: science, experimental development, mass production,” said Mikhail Myasnikovich. “It is top class when a joint venture is established to make cutting-edge patented medications.” Mikhail Myasnikovich also underlined the high level of Belarusian science. The interest world companies show in Belarusian science confirms it.

A pharmaceutical enterprise will be established at Academpharm premises to make medications to treat HIV infection, hepatitis B and C among other things. The Indian company will provide modern technologies and techniques for the sake of the project’s implementation: micronization, dry granulation, and multilayered pills. The R&D center is expected to manufacture medications using a complete cycle – from a scientific idea to manufacturing. The facility is supposed to open in spring 2020.

Founded in 1935, Cipla Limited is focused on development, chemical synthesis, and production of over 1,500 ready-made medications. It offers antitumor medications, bronchodilators, corticosteroids, immunosuppressants, chemotherapeutic and antiretroviral agents, antibiotics, and antidepressants. Cipla Limited is present in 150 countries across the globe.

This article originally appeared in Belarus News

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