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Policy & Regulation

FDA approves Colorcon’s iron oxide petition to expand colour spectrum

FDA approves Colorcon’s iron oxide petition to expand colour spectrum

2018-11-07

Colorcon's petition for the use of iron oxide as a colour additive for use in dietary supplement tablets and capsules has now been approved

Global demand for biosurfactants set to be worth over $2.7-bn by 2024

Global demand for biosurfactants set to be worth over $2.7-bn by 2024

2018-11-07

Global demand for biosurfactants set to be worth over $2.7-bn by 2024

FDA approves Colorcon’s iron oxide petition to expand colour spectrum

FDA approves Colorcon’s iron oxide petition to expand colour spectrum

2018-11-05

FDA approves Colorcon’s iron oxide petition to expand colour spectrum

Alembic announces successful USFDA inspection at joint venture

Alembic announces successful USFDA inspection at joint venture

2018-11-05

Aleor was formed in April 2016 to develop, manufacture and commercialise dermatology products for worldwide markets. Till date the company has filed six ANDAs.

Global Bioenergies reaches 87% of yield target in bio-based isobutene process

Global Bioenergies reaches 87% of yield target in bio-based isobutene process

2018-11-01

Global Bioenergies reaches 87% of yield target in bio-based isobutene process

Alembic announces successful USFDA inspection at joint venture

Alembic announces successful USFDA inspection at joint venture

2018-11-01

Alembic announces successful USFDA inspection at joint venture

Middle East and Africa pharma economy to reach US$38.8 bn by 2021

Middle East and Africa pharma economy to reach US$38.8 bn by 2021

2018-10-29

“The Middle East and Africa market is evolving at a rapid pace, and opportunities are plentiful for regional and international pharma co...

Middle distillate prices on uptrend in Asia amid strong demand, tight supply

Middle distillate prices on uptrend in Asia amid strong demand, tight supply

2018-10-26

On paper, the prompt November/December Singapore jet fuel/kerosene timespread was assessed at 10 cents/b Tuesday, up 29 cents/b from Monday.

Strong policies needed to clean Delhi NCR air by 2025

Strong policies needed to clean Delhi NCR air by 2025

2018-10-25

A joint scientific study report by commissioned by the Ministry of Heavy Industries & Public Enterprises and conducted by The Energy Resources Institute (TERI) and the Automotive Research Association of India (ARAI) has said that strong policies are n

Asian benzene-naphtha spread tumbles on weak benzene demand, firmer naphtha valu

Asian benzene-naphtha spread tumbles on weak benzene demand, firmer naphtha valu

2018-10-22

Benzene's premium to feedstock naphtha in Asia has shrunk more than $100/mt over the past six weeks as growing length in the benzene market weighs on prices while naphtha cargo values have firmed on the back of the recent crude oil rally.

Sun Pharma gets regulatory observations from USFDA

Sun Pharma gets regulatory observations from USFDA

2018-10-19

The US regulator makes Form 483 observations when companies don’t adhere to procedures outlined in the current Good Manufacturing Practices (cGMP) norms. Companies are expected to revert with their remedial action. But the issue could escalate if the acti

Draft guidelines for online pharmacies raise over-regulation worries

Draft guidelines for online pharmacies raise over-regulation worries

2018-10-17

The recently released draft guidelines for the online pharmacy industry have raised several questions for players operating in the burgeoning space, including on a possible overlapping role of state governments. The gazette notification, released on Augus

Glenmark receives ANDA approval for steroidal drug from US FDA

Glenmark receives ANDA approval for steroidal drug from US FDA

2018-10-17

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the US FDA for Estradiol Vaginal Inserts USP, 10 mcg, the generic version of Vagifem1, 10 mcg, of Novo Nordisk Inc.According to IQVIA sales data for the 12-month period ending July 20

Fragrance ingredient market set to reach $18.5bn by 2024

Fragrance ingredient market set to reach $18.5bn by 2024

2018-10-16

Brazil’s fragrance ingredients sector is also forecast for strong growth due to its increased demand for luxury fragrance products.

Price control, ad-hoc regulatory changes and new policies may hamper pharma sect

Price control, ad-hoc regulatory changes and new policies may hamper pharma sect

2018-10-12

Leading pharma firm, Pfizer, fears that the pharma industry is expected to face challenges from price controls, ad-hoc regulatory changes and new policies that may impact sustainable growth.

Janssen submits MAA to EMA for esketamine nasal spray

Janssen submits MAA to EMA for esketamine nasal spray

2018-10-12

Johnson & Johnson’s Janssen Pharmaceutical Companies has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its esketamine nasal spray.

FDA Approves Stiolto Respimat sNDA to Add Data on COPD Exacerbation Reduction

FDA Approves Stiolto Respimat sNDA to Add Data on COPD Exacerbation Reduction

2018-10-12

Boehringer Ingelheim announced the U.S. Food and Drug Administration (FDA) approved new labeling for Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by

Rigel Receives EMA Validation for Fostamatinib

Rigel Receives EMA Validation for Fostamatinib

2018-10-12

"The EMA's validation of our MAA is an important milestone in the execution of our global commercial strategy for fostamatinib for the t...

Sun Pharma and SPARC announce US FDA nod for glaucoma drug

Sun Pharma and SPARC announce US FDA nod for glaucoma drug

2018-10-10

Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. (SPARC) have announced USFDA approval for the New Drug Application (NDA) of Xelpros (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressur

New Mineral Policy to set out royalty structure: Ministry of Mines

New Mineral Policy to set out royalty structure: Ministry of Mines

2018-09-03

Speaking at the ‘National Summit on Mineral Exploration and Sustainability’, organised by FICCI with the support of the International Institute of Corporate Sustainability and Responsibility (IICSR), Mr. Pathak said the new policy would be industry-friend

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